Drospil

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Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Drospil

Quick Facts

Property Description
Active Ingredients Drospirenone and Ethinyl Estradiol
Form Film-coated Oral Tablet
Pharmacological Class Combined hormonal contraceptive
Typical Use Prevention of pregnancy (Contraception)
Legal Status Prescription-only (-only)

What Type of Medicine is Drospil?

Drospil is a type of Combined Oral Contraceptive (COC), a prescription-only medication supplied as a film-coated tablet for oral administration. It belongs to the high-level pharmacological class of Sex Hormones and Modulators of the Genital System. Drospil is a synthetic medication that contains man-made versions of two female sex hormones, an estrogen and a progestin.

What is Drospil's Composition?

Drospil is a combination product containing the estrogen Ethinyl Estradiol and the progestin Drospirenone. This dual hormonal structure is responsible for its effectiveness in suppressing ovulation. The progestin component, Drospirenone, is characterized by its unique anti-mineralocorticoid activity. This property means the hormone may help counteract the tendency for fluid retention and bloating often associated with other hormonal contraceptives.

What is the General Purpose of Drospil?

The principal general purpose of taking Drospil is contraception, which reliably prevents pregnancy. The combined hormones work primarily by suppressing the hormonal signals that trigger ovulation. This method provides women with continuous control over their fertility planning.

Regulatory References

  1. NIH MedlinePlus

What side effects are possible with Drospil?

Possible Side Effects and Safety Information

The safety profile of Drospil, a combined hormonal contraceptive containing Drospirenone and Ethinyl Estradiol, is documented in official regulatory sources, addressing both common systemic effects and serious adverse reactions.

Documented Adverse Reactions and Frequency

Adverse reactions are classified by frequency, with the most commonly reported effects reflecting disruptions in the female reproductive system and central nervous system. Reactions classified as very common (ge 1 in 10) include headache. Effects categorized as common (ge 1 in 100 to < 1 in 10) typically involve depressive mood, migraine, nausea, breast tenderness, and menstrual cycle disturbances.

Less frequent adverse reactions classified as uncommon may include hypertension, dizziness, vomiting, and weight increase. The most significant safety considerations, such as Venous Thromboembolism (VTE) and Arterial Thromboembolism (ATE), are categorized as rare (le 1 in 1,000) but are considered serious adverse reactions in regulatory documentation.

Serious Adverse Reactions and Constraints

The use of combined oral contraceptives is associated with an increased risk of VTE and ATE (including stroke and myocardial infarction), with the risk generally highest during the first year of use. This vascular risk is specifically increased in women who smoke, particularly those aged over 35 years, which constitutes a major safety constraint in official labeling.

Due to the specific anti-mineralocorticoid activity of Drospirenone, there is a potential for hyperkalemia (elevated serum potassium). Consequently, the medicine is officially contraindicated in individuals with pre-existing conditions such as renal impairment, adrenal insufficiency, or severe hepatic disease, as documented in government prescribing information.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory documentation for Drospil (Drospirenone and Ethinyl Estradiol) defines the manifestations and required response for acute over-ingestion of the hormone-containing tablets. Based on general experience with combined oral contraceptives, the documented presentation of overdose is typically characterized by generally mild, transient effects.

Documented Overdose Manifestations

Clinical Signs Population-Specific Notes
Nausea None documented for adults
Vomiting None documented for adults
Withdrawal bleeding (Vaginal bleeding) May occur in girls before their menarche (pre-pubertal females)

Required Emergency Actions

The primary trigger for seeking medical attention in the event of an overdose is to secure appropriate management for the documented manifestations. No explicitly severe or life-threatening outcomes are documented as consequences of an acute overdosage. Management of Drospil overdose must be symptomatic and supportive. No specific chemical antidote is known or documented in the official prescribing information.

Medical assistance is required to manage the documented symptoms and to ensure proper care, particularly in cases involving accidental ingestion by a pre-pubertal female, due to the documented potential for withdrawal bleeding.

Therapeutic Uses of Drospil

What Drospil Treats: Main Uses and Benefits

Drospil is applied in clinical contexts primarily to provide support for the prevention of pregnancy and is used for managing two specific, approved non-contraceptive conditions. These uses are considered relevant in situations where patients seek long-term fertility control alongside symptom management for certain conditions. The combination is relevant for contraception, severe premenstrual dysphoric disorder (PMDD), and moderate acne vulgaris.


Treatment of Specific Conditions and Symptom Clusters

Drospil is used for managing symptoms related to PMDD, a condition characterized by a severe, cyclical pattern of emotional and physical symptoms that clusters specifically during the premenstrual phase. This symptomatic relief may assist with maintaining functional stability, offering support that helps patients cope more steadily with these difficult, recurrent episodes. The medication is also commonly used for managing symptoms related to moderate acne vulgaris in women seeking contraception. This may assist with maintaining day-to-day comfort and managing symptoms related to inflammatory states, and may help ease symptoms related to cyclical bloating and physical discomfort.


Quick Fact: Relief for PMDD
Symptom Cluster Severe mood swings, irritability, anxiety, and depressed mood.
Benefit Assists with maintaining functional stability during the premenstrual phase.
Quick Fact: Relief for Acne and Bloating
Symptom Cluster Inflammatory skin lesions and cyclical fluid retention/bloating.
Benefit May contribute to enhanced day-to-day comfort and supports managing symptoms related to skin appearance.

Regulatory References

  1. NIH DailyMed/FDA Label

Eligibility and Restrictions for Use

Who can and cannot use Drospil?

The use of Drospil (a combination of drospirenone and ethinyl estradiol) is restricted to females of reproductive potential and is not indicated for use after menopause or before the start of menstruation.

Populations for Whom Use is Contraindicated

Drospil must not be used by individuals with certain pre-existing conditions, as outlined in official regulatory documents. These contraindications are primarily related to major health risks and include:

  • Vascular/Thrombotic Risk: A high risk of arterial or venous thrombotic diseases, such as a history of deep vein thrombosis, pulmonary embolism, stroke, or heart attack.
  • Specific Risk Group: Females over 35 years old who smoke, due to a significantly increased risk of serious cardiovascular events.
  • Renal/Adrenal Impairment: The presence of renal impairment or adrenal insufficiency, which increases the risk of hyperkalemia (high potassium levels) due to the drospirenone component.
  • Liver Disease/Tumors: The presence of liver tumors (benign or malignant) or active, acute, or chronic liver disease, or hepatic impairment.
  • Hormone-Sensitive Malignancy: A current or history of breast cancer or any other cancer known to be sensitive to female hormones.
  • Undiagnosed Bleeding: Undiagnosed abnormal uterine bleeding.
  • Pregnancy: Use is strictly contraindicated during known or suspected pregnancy. Use is also not recommended in the immediate postpartum period, particularly while breastfeeding, due to cardiovascular risk and potential effects on milk production.

What should I know about interactions with other medicines?

Drospil (containing drospirenone) has documented drug interactions that fall into three main regulatory categories: agents that affect its metabolism, drugs that may increase serum potassium, and specific antiviral combinations.

Documented Interaction Categories

Interaction Type Examples of Interacting Medicines/Classes Regulatory Constraint
Increased Systemic Exposure Strong CYP3A4 Inhibitors (e.g., ketoconazole, strong HIV/HCV protease inhibitors) Risk of hyperkalemia; Serum potassium concentration monitoring is required in high-risk patients on long-term co-administration.
Reduced Effectiveness CYP3A4 Inducers (e.g., carbamazepine, rifampicin, St. John's Wort) Alternative or back-up contraceptive method must be used during and for 28 days after discontinuation of the inducer.
Hyperkalemia Risk Potassium-sparing diuretics, ACE inhibitors, ARBs, NSAIDs, Potassium supplements Monitoring of serum potassium concentration is required during the first treatment cycle when co-administered long-term.
Contraindicated Combination Hepatitis C combinations containing ombitasvir/paritaprevir/ritonavir (with or without dasabuvir) Use is contraindicated due to risk of liver enzyme elevations.

The regulatory documentation emphasizes that drospirenone’s anti-mineralocorticoid activity creates a pharmacodynamic risk of hyperkalemia when co-administered with other potassium-increasing drugs. In this context, use is contraindicated in females with underlying conditions that predispose to hyperkalemia, such as renal or adrenal insufficiency. These constraints define the required management protocol for concurrent medication use.

Mechanism of Action

Drospil, containing drospirenone, modulates systemic physiology through multiple receptor interactions. Drospirenone functions as an agonist at the progesterone receptor (PR), primarily located in the hypothalamus, pituitary gland, and reproductive tissues. PR activation suppresses the pulsatile release of gonadotropin-releasing hormone (GnRH) from the hypothalamus, leading to a subsequent systemic reduction in the secretion of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) from the anterior pituitary.

Simultaneously, drospirenone acts as a high-affinity antagonist at the mineralocorticoid receptor (MR) in the kidney tubules. By blocking MR, drospirenone prevents the transcriptional effects of aldosterone, specifically inhibiting the expression and activity of the epithelial sodium channel (ENaC). This leads to decreased renal reabsorption of sodium ions and an associated increase in water excretion, causing systemic fluid and electrolyte modulation. Furthermore, drospirenone exhibits antagonist activity at the androgen receptor (AR), blocking the nuclear translocation and transcriptional activity of endogenous androgens.

Dosage and Administration Information

Drospil is a prescription oral medication containing drospirenone, dispensed in blister packs intended for a continuous 28-day administration cycle. Use of the medicine must strictly adhere to the dosing and sequence detailed in the official product labeling.

Administration Requirements

Guideline Official Instruction
Route of Administration Oral (Swallow whole or chew, as applicable to the tablet formulation).
Dosing Schedule Take one tablet daily for 28 consecutive days. The interval between two tablets must always be 24 hours.
Timing & Food Take the tablet at about the same time each day; may be taken with or without food.

Procedural Sequence

Tablets must be taken in the exact order directed on the blister pack. Each cycle includes a specific number of active tablets (typically 21 or 24 days) followed by inactive (placebo) tablets (typically 4 or 7 days).

  1. Starting the First Pack: Begin with the first active tablet on Day 1 of the menstrual cycle (the first day of menstrual bleeding). If started later than Day 1, a non-hormonal barrier method is required for the first 7 consecutive days of active tablet use.
  2. Subsequent Packs: Begin the next 28-day pack on the day immediately following the last tablet of the previous pack, regardless of whether a withdrawal bleed is occurring.

Missed Dose Instructions

Official instructions detail actions for missed tablets, which may vary depending on the product formulation and the week the tablet was missed. In general:

  • Missed Active Tablet: Take the missed active tablet as soon as possible, even if it means taking two tablets in one day, and continue the pack at the regular time. If multiple active tablets are missed, a non-hormonal barrier method is required until 7 consecutive active tablets have been taken.
  • Missed Inactive Tablet: Skip the missed inactive tablet and continue with the remaining tablets in the pack at the usual time.

If severe vomiting or diarrhea occurs within 3–4 hours of taking an active tablet, absorption may be incomplete, and the procedure for a missed tablet must be followed.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Drospil


Evidence for Use in Preventing Pregnancy (Contraception)

The primary body of research related to the use of the combined hormones in Drospil for preventing pregnancy comes from large-scale, non-comparative Phase III clinical trials. These studies assessed the rate of unintended pregnancy, frequently using the Pearl Index measurement. The findings describe patterns observed in the studies that consistently tracked low rates of unintended pregnancy when the medication was observed in the study populations. This evidence is also complemented by years of observational research conducted in real-world settings.

However, limited information exists for long-term outcomes from controlled studies directly comparing this specific combination to all other available hormonal contraceptives solely on the basis of pregnancy prevention rates. The long-term assessment of health outcomes may rely on large-scale observational studies.


Evidence for Use in Premenstrual Dysphoric Disorder (PMDD)

Research related to the evaluation of Drospil for severe PMDD primarily utilized randomized, placebo-controlled clinical trials (RCTs). These studies were evaluated in women meeting strict diagnostic criteria for PMDD. The trials tracked changes in symptom intensity using validated patient-reported tools over three treatment cycles (about three months).

The trials focused on tracking patterns observed in the study groups and how patient-reported mood, behavioral, and functional outcomes evolved compared to the placebo group. Because the main body of evidence focused on short-term symptom changes, long-term effects are not fully established, and follow-up durations were limited in these core studies. Comparative evidence remains sparse against other treatments studied for PMDD.


Evidence for Use in Moderate Acne Vulgaris

Research related to moderate acne vulgaris was evaluated in females who required oral contraception. The primary evidence is based on randomized, placebo-controlled trials conducted over six treatment cycles (about six months). The studies explored outcomes linked to skin appearance by monitoring changes in inflammatory and non-inflammatory lesions and assessing the overall appearance of the skin.

The findings describe patterns observed only in the populations studied—women who simultaneously sought contraception. Data for certain groups remain insufficient, such as men, women who do not require contraception, or individuals with severe cystic acne. There is also limited information for long-term outcomes on how the monitored outcomes are maintained once the six-month observation period is complete.

Key Studies & References YAZ (drospirenone and ethinyl estradiol) Tablets U.S. Prescribing Information (DailyMed/NIH)

Frequently Asked Questions (FAQ)

Common questions about Drospil (FAQ)


Q: What is the main difference between Drospil and other similar medicines?

Drospil contains a progestin called drospirenone. Official documents state that this progestin is described as having anti-mineralocorticoid activity (which can relate to fluid retention) and anti-androgenic activity (which can relate to certain skin conditions), based on its pharmacological profile. These specific activities distinguish it from some other progestins used in combined hormonal medicines.


Q: How long does it usually take to notice the effects of Drospil?

For the purpose of contraception, regulatory documents state that a non-hormonal barrier method is required for the first seven consecutive days of active tablet use if the medicine is started outside of the recommended time. Full therapeutic benefit for conditions like PMDD or acne was generally evaluated over several cycles (e.g., three to six months) in clinical studies.


Q: Why is Drospil prescribed for conditions other than its main use?

Official regulatory documents indicate that, in addition to preventing pregnancy, the medicine is also approved for treating symptoms of Premenstrual Dysphoric Disorder (PMDD) and moderate acne vulgaris in women who also desire oral contraception. These are established regulatory indications supported by clinical evidence.


Q: Does Drospil have long-term side effects that official documents mention?

Official safety documents indicate that the risk of serious side effects, such as Venous Thromboembolism (VTE) or blood clots, is described as being highest during the first year of use or when restarting the medicine after a break of four weeks or more. The need for continued use is often subject to periodic re-evaluation.


Q: Are there any specific supplements or vitamins that should not be taken with Drospil?

Official prescribing information notes that supplements containing Potassium or the herbal product St. John's Wort are examples of agents that may interact and require monitoring or caution. Potassium supplements may increase the risk of high potassium levels, while St. John's Wort may potentially reduce the medicine's effectiveness.


Q: Is Drospil considered a high-risk medication in official safety classifications?

Official prescribing information for this class of medicine notes an association with an increased risk of serious cardiovascular events, including blood clots, stroke, and heart attack. Official labeling highlights this risk, especially for women who are over 35 and who smoke.


Q: Are there common reasons why people stop taking Drospil?

Clinical trial data lists various side effects as reasons for discontinuation. Commonly reported adverse reactions that may lead to stopping the medicine include headache, nausea, breast tenderness, and changes in menstrual bleeding patterns.


Q: Is Drospil a medicine that needs to be taken indefinitely?

There is no set maximum duration for using the medicine as long as contraception is desired or while the condition being treated requires management. However, the need for continued use is often subject to periodic re-evaluation, based on treatment goals.


Q: What are the possible interactions between Drospil and commonly used pain relievers?

Official information explicitly lists Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), a class of common pain relievers, as a medicine that can interact. When co-administered long-term, NSAIDs may increase the risk of hyperkalemia (high potassium levels) due to the drospirenone component.


Q: Do food or drink affect how Drospil works in the body?

Official regulatory documents state that the tablet may be taken with or without food. However, some regulatory sources note that consuming grapefruit or grapefruit juice may potentially interfere with how the body processes the medicine.


Q: Can Drospil affect the results of common laboratory tests?

Official prescribing information notes that oral contraceptives may influence the results of certain laboratory tests. These include tests for parameters of liver, thyroid, adrenal, and renal function, as well as protein and lipid binding.


Q: Is it true that Drospil can affect my mood or energy levels?

Official safety information lists depressive mood and migraine as commonly reported side effects. These central nervous system effects are described in regulatory documents. Changes in mood and energy are also noted as features of PMDD, which the drug is indicated to treat.


Q: Is there a generic version of Drospil available, and is it considered the same?

Once patent protection expires, generic versions of the medicine are typically approved by government agencies. These approved generics are considered bioequivalent and therapeutically interchangeable with the brand-name version, meaning they are expected to work in the same way.


Q: What is the 'half-life' of Drospil, and what does that mean?

The half-life refers to the time it takes for the concentration of the medicine in the bloodstream to be reduced by half. For the active ingredient drospirenone, the terminal half-life is approximately 30 hours after multiple dosing.


Q: Are there specific diet restrictions mentioned in official documents for Drospil?

Official regulatory information does not list broad dietary restrictions. The main food-related caution noted in some sources is to avoid grapefruit or grapefruit juice, as this fruit may interfere with how the body processes the medicine.


Q: Can Drospil affect fertility in men or women?

The medicine functions to prevent pregnancy. Regulatory documents state that its use is not associated with long-term effects on future fertility, and normal fertility is generally observed to return after discontinuation of the medicine.


Q: Is Drospil considered a controlled substance in any regions?

In most jurisdictions, Drospil is classified as a prescription-only medicine. It is generally not categorized as a federally controlled substance, which applies to medicines with a high potential for abuse or dependency.


Q: Do lifestyle factors like smoking or exercise impact Drospil's effectiveness?

Official warnings note that cigarette smoking is associated with a significantly increased risk of serious cardiovascular events, especially in women over 35. The documents emphasize this safety concern but do not state that smoking or exercise directly reduces the contraceptive effectiveness.


Q: What kind of monitoring might be necessary while taking Drospil?

Regulatory guidance describes that periodic monitoring of blood pressure may be performed. Additionally, monitoring of serum potassium concentration is required when co-administering certain interacting drugs.


Q: Why are people with kidney problems sometimes advised caution with Drospil?

The medicine is officially contraindicated (must not be used) in patients with renal impairment or adrenal insufficiency. This is because the drospirenone component can affect potassium levels, and these conditions increase the risk of developing dangerously high potassium levels (hyperkalemia).


Q: What are the ingredients in Drospil besides the active substance?

Official product information lists the excipients (inactive ingredients) in the tablet, which help form the pill and provide the coating. These typically include substances such as lactose, magnesium stearate, and microcrystalline cellulose.


Q: Is there a possibility of an allergic reaction to Drospil ingredients?

As with all medicines, there is a possibility of experiencing a serious allergic reaction (hypersensitivity) to either the active hormones or any of the inactive ingredients. Official labeling categorizes this as a rare adverse reaction.


Q: What is known about the maximum time Drospil can be taken?

Official documents state there is no specific maximum duration of use for contraception. However, the continuation of the medicine is subject to periodic re-evaluation based on the patient's treatment goals.


Q: Does Drospil cause weight changes, according to the research evidence?

Clinical trial data lists weight increase as an uncommon side effect. Additionally, the official documents note that weight gain is a symptom of Premenstrual Dysphoric Disorder (PMDD), a condition the medicine is indicated to treat.

How should Drospil be stored and disposed of?

Storage and Disposal of Drospil

Drospil (drospirenone and ethinyl estradiol) tablets must be stored according to official regulatory specifications to maintain chemical stability. The required storage environment is Controlled Room Temperature, defined as 20 C to 25 C (68 F to 77 F). The medication must be protected from excess heat and moisture and should remain in the container it came in, tightly closed, until ready for use.

As a mandatory safety measure, the tablets must be stored out of the reach of children. Unused or expired tablets must be discarded in compliance with local regulations. Patients are instructed to dispose of unused product according to their local regulatory protocols, and to throw away medication after its expiration date.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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