Stezza

Quick links to important sections

Stezza

Treatment option:

Medically reviewed

Marina Burgos

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 Stezza

What is Stezza?

Stezza is a combined oral contraceptive pill used primarily for the prevention of pregnancy. It is categorized as a monophasic hormone replacement or contraceptive treatment, meaning each active tablet in a blister pack contains the same dose of hormones.

Composition and Mechanism

This medication contains two different types of active hormones:

  • Nomegestrol acetate: A progestogen, which is a synthetic form of the natural hormone progesterone.
  • Estradiol: An estrogen that is chemically identical to the hormone naturally produced by the ovaries.

Stezza works to prevent pregnancy through several physiological mechanisms. The primary action is the inhibition of ovulation, which is the release of an egg from the ovaries. Additionally, the hormones alter the consistency of the cervical mucus, making it more difficult for sperm to reach an egg, and change the lining of the uterus to reduce the likelihood of a fertilized egg attaching itself.

Tablet Cycles

A typical blister pack of Stezza consists of 28 tablets. This includes 24 active tablets containing the hormones and 4 inactive or placebo tablets. The inclusion of placebo tablets is intended to maintain a daily habit and facilitate a regular withdrawal bleed, which mimics a menstrual period.

What side effects are possible with Stezza?

Stezza is a medication that carries risks and potential side effects, as documented in regulatory health information. Users should be aware of serious adverse events and common reactions reported in clinical data and post-marketing surveillance.

Serious Safety Considerations

The most significant risks associated with the use of this type of medication include blood clots, which may lead to life-threatening events such as deep vein thrombosis (DVT), pulmonary embolism, stroke, or heart attack. The risk of these cardiovascular events is markedly increased in individuals who smoke, particularly those over the age of 35.

Other clinically important warnings involve the potential for increased blood pressure (hypertension), development or worsening of migraine headaches, and the risk of liver damage or gallbladder problems. There is also a risk of high potassium levels (hyperkalemia), especially when taken with other medicines that increase serum potassium.

Common Adverse Reactions

The most frequently reported side effects in clinical trials typically involve systemic and reproductive system changes. These common reactions may include:

  • Changes in menstrual bleeding (irregular periods, spotting)
  • Nausea or vomiting
  • Headache or migraine
  • Breast tenderness or discomfort
  • Mood changes, including depression
  • Weight increase

Required Safety Monitoring

Due to the risk of serious complications, health authorities emphasize the importance of monitoring. Blood pressure should be periodically checked, and patients must be assessed for symptoms of blood clots or liver injury. Continued use requires consultation, especially if new or worsening medical conditions occur.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory documentation for Stezza (Nomegestrol acetate and Estradiol) defines the potential consequences and required actions for overexposure based on clinical data. The documented overdose manifestations reported in regulatory summaries are generally limited to non-serious effects. These presentations include gastrointestinal symptoms such as nausea and vomiting.

Official prescribing information confirms that there have been no reports of serious or life-threatening adverse effects specifically attributed to an overdose of this product in clinical trials. This regulatory classification defines the severity of the overdose profile. A population-specific manifestation is documented regarding the effect on the genital system: slight vaginal bleeding is noted as a potential consequence of overexposure, particularly in young girls (pre-menarcheal patients).

Regarding emergency management, the regulatory sources explicitly state that there is no specific antidote known for an overdose of this combined oral contraceptive. The mandated response is that further treatment must be symptomatic and supportive only. Urgent medical consultation is required when overexposure is suspected to ensure appropriate assessment and symptomatic care. This action, dictated by the lack of an antidote, is the official procedural instruction for managing an overdose.

Therapeutic Uses of Stezza

What Stezza Treats: Main Uses and Benefits

The primary therapeutic role of Stezza (nomegestrol acetate and estradiol) is to provide Oral Contraception for women of childbearing age, primarily used to help provide reliable and continuous pregnancy prevention. Its core purpose is fertility control. This use also contributes to a more stable hormonal environment, relevant in contexts where additional symptomatic support is needed. The medication is commonly used across conditions presenting with episodic or fluctuating manifestations, notably managing pronounced symptoms like painful menstruation (dysmenorrhea), heavy menstrual bleeding (menorrhagia), hormone-driven acne, and severe, cyclically recurring premenstrual mood changes.

“This formulation provides support that helps ease the overall symptom load during periods of heightened discomfort.”

This supportive benefit helps ease the overall symptom load and supports improved day-to-day comfort. By supporting the patient during these difficult episodes, the medication may assist with maintaining functional stability and helps patients cope more steadily with symptom fluctuations that interfere with daily functioning.


Quick Fact

Property Description
Relief for Painful menstruation (dysmenorrhea) and heavy menstrual bleeding (menorrhagia)
Symptom Focus Gynecological discomfort and hormone-sensitive manifestations (e.g., acne, mood changes)
Primary Context Continuous fertility control and cycle stabilization
Patient Benefit Supports maintenance of functional stability and coping with symptom fluctuations

Eligibility and Restrictions for Use

Who Can and Cannot Use Stezza?

This section summarizes the population eligibility rules for Stezza (Nomegestrol acetate and Estradiol) as defined by official regulatory labeling, detailing who is permitted to use the medicine and the conditions that strictly prohibit its use.


Approved and Restricted Populations

Category Eligibility Status
Target Age Group Indicated for women of childbearing age [Source: FDA, EMA].
Pediatric Use Contraindicated in pre-pubertal females; use is not established [Source: EMA].
Geriatric Use Not indicated for use in postmenopausal women [Source: FDA, EMA].
Breastfeeding Not recommended during lactation, as hormonal components pass into breast milk [Source: EMA].

Absolute Contraindications

Stezza is contraindicated and must not be used by patients with:

  • A current or history of venous thromboembolism (VTE) or arterial thromboembolism (ATE) (e.g., DVT, stroke, myocardial infarction).
  • Known thrombogenic mutations (e.g., Factor V Leiden).
  • Severe hepatic disease with impaired function or liver tumors.
  • Known or suspected breast cancer or other hormone-sensitive cancers.
  • Diabetes mellitus with vascular involvement or undiagnosed abnormal uterine bleeding [Source: FDA, EMA].

What should I know about interactions with other medicines?

Interactions with other medicines and products

The regulatory profile for this combination medicine focuses on the potential for other substances to alter the plasma levels of the hormonal components, which is described as a risk of reduced contraceptive effectiveness. The official documentation identifies several classes of interacting medicines based on their effect on metabolism or transport.

Documented Interaction Patterns

Classification Interacting Substances/Classes
Contraindicated Combinations Specific regimens for treating Hepatitis C, including Ombitasvir/Paritaprevir/Ritonavir pm Dasabuvir and Glecaprevir/Pibrentasvir, are formally prohibited for co-administration due to the documented risk of severe liver enzyme elevation.
Reduced Exposure/Efficacy Medicines classified as Enzyme Inducers (e.g., Rifampicin, certain Antiepileptics like Phenytoin and Carbamazepine) and herbal products containing St John’s Wort may reduce the therapeutic effect due to decreased hormonal plasma concentrations.
Increased Exposure Strong enzyme inhibitors, such as Ketoconazole, are documented to increase the serum concentration of Nomegestrol acetate.
Impact on Other Drugs The medicine may decrease the therapeutic efficacy of co-administered Anticoagulants and is documented to increase the serum concentration of Corticosteroids.

Absorption and Timing Constraints

Substances like Cholestyramine may reduce Nomegestrol acetate concentrations due to impaired absorption. The official regulatory text indicates that no interaction is expected with alcohol; however, no mandatory time-separation requirements are explicitly detailed for co-administered medicines.

Mechanism of Action

Stezza is a combination pharmacological agent containing a progestogen, Nomegestrol acetate (NOMAC), and an estrogen, 17beta-Estradiol ( E2). The mechanism involves the combined actions of both compounds primarily on the hypothalamic-pituitary-ovarian (HPO) axis.

Nomegestrol acetate, a synthetic progestin derivative, functions as a high-affinity agonist of the progesterone receptor (PR). This PR activation mediates a potent anti-gonadotropic effect at the level of the hypothalamus and pituitary gland, leading to the suppression of Luteinizing Hormone (LH) and Follicle-Stimulating Hormone (FSH) secretion. This suppression prevents the ovarian follicular development and subsequent release of the oocyte, thereby inhibiting ovulation.

The NOMAC component also induces a physicochemical change in the cervical mucus, increasing its viscosity to impede sperm migration. Concurrently, it modulates the endometrium, prompting a conversion to a secretory phase that is less proliferative. The 17beta-Estradiol component complements the gonadotropin suppression to enhance follicular inhibition and contribute to the overall physiological consequences.

Dosage and Administration Information

How to Use Stezza

The administration of Stezza (nomegestrol acetate and estradiol) is based on a structured, continuous 28-day oral regimen. The medication is delivered exclusively via the oral route using film-coated tablets.


Official Dosing and Cycle Structure

The standard regimen consists of taking one tablet daily for 28 consecutive days. This cycle is precisely divided into 24 white active tablets and 4 yellow placebo tablets. Each white tablet delivers the fixed dose of 2.5 mg nomegestrol acetate and 1.5 mg estradiol. A new pack must be started immediately upon completion of the preceding 28-day pack, ensuring no tablet-free interval occurs.

Instruction Category Official Guidelines
Route of administration Oral use via film-coated tablets.
Dosing schedule One tablet taken daily in a 24 active / 4 placebo sequence.
Frequency and Timing Once daily, at about the same time every day.

Administration Requirements

Tablets must be taken in the exact order directed on the blister and swallowed whole with some liquid. Intake is not dependent on meals and can occur irrespective of food consumption. Strict adherence to the daily timing is required; if a white active tablet is delayed by less than 12 hours, it should be taken immediately to maintain the prescribed use pattern. If the delay exceeds 12 hours, specific actions are required based on the timing within the cycle. The safety and effectiveness of the regimen have not been established in adolescents under 18 years of age.

Recent Clinical Evidence

Research evidence / Overview of studies for Stezza

Evidence for Use in Contraception and Pregnancy Prevention

The evidence base includes several large, international Randomized Controlled Trials (RCTs). These main studies enrolled healthy, sexually active women of childbearing age and focused on outcomes related to preventing pregnancy. Researchers also examined key metrics related to fertility control and monitored the Pearl Index, which is a way to calculate the rate of unintended pregnancies observed during the study.

Extended observational surveillance studies monitored outcomes over periods lasting up to seven years. These studies reported how patients reported their experience during the observation period. It is important to understand the context of this research: the main RCTs used an active hormonal contraceptive as a comparator, rather than a placebo, due to ethical constraints related to pregnancy prevention trials. This means comparative evidence is lacking for a direct assessment against placebo.

Evidence for Use in Managing Menstrual Symptoms

Research was evaluated in studies examining patient-reported experiences related to physical discomfort. This research primarily involved comparative studies and post-hoc analyses of data collected during the main contraceptive trials. Studies explored how symptoms changed in the observed populations, particularly for painful menstruation (dysmenorrhea).

Research examined changes in patient-reported menstrual pain scores and monitored the reported need for supplementary pain-relieving medication among study participants. The evidence quality varies across studies because a significant portion of the data is drawn from these secondary or post-hoc analyses, where symptom reporting was not the primary focus.

Current Gaps and Areas of Research Uncertainty

Scientific reviews highlight several areas where evidence is still emerging or where the level of certainty remains low. For the secondary uses, such as symptom management and mood-related outcomes, evidence quality varies across studies and much of the data comes from smaller, less definitive studies. Specifically, future research is indicated to examine outcomes related to mood or affective conditions, as findings in these areas are still emerging.

Frequently Asked Questions (FAQ)

Common questions about Stezza (FAQ)

Q: How quickly does Stezza usually start to work?

Official product information indicates that the full contraceptive benefit of Stezza is considered established after taking the white active tablets for seven consecutive days. If the medication is started later than directed in the cycle, regulatory documents indicate the need for using an additional barrier method of contraception until this seven-day period is complete.

Q: Is Stezza a long-term treatment or just for short periods?

The official regimen for Stezza consists of taking one tablet daily for 28 consecutive days, continuing without a break between packs. Regulatory labeling does not specify a maximum time period for use, which is consistent with the drug being prescribed for ongoing, long-term contraception.

Q: Does Stezza interact with common pain relievers like ibuprofen or acetaminophen?

According to regulatory documents, common over-the-counter pain relievers such as ibuprofen and acetaminophen are generally not listed as interacting drugs that affect the contraceptive effectiveness of Stezza. A review of the full regulatory information is advised if there are any concerns about combining medications.

Q: Are there any foods or drinks that should be avoided when taking Stezza?

Official product information indicates that Stezza tablets must be taken without regard to meals. There are no specific food or drink restrictions noted in regulatory labeling.

Q: How long does the effect of a Stezza dose last in the body?

The official product information includes data on pharmacokinetics, which describes how the body handles the medicine. The active ingredient nomegestrol acetate has an elimination half-life of approximately 46 hours, which supports the drug’s once-daily dosing schedule.

Q: What happens if I miss a dose of Stezza?

The specific approach to managing a missed tablet is detailed in the patient information leaflet. Official guidelines state that the action needed depends on whether the pill was missed by more than 12 hours and where the missed dose falls within the 28-day cycle.

Q: Is it true that Stezza has a specific warning from the FDA or other regulatory body?

Yes. Stezza is a combined hormonal contraceptive and, according to official regulatory warnings, is associated with a risk of serious adverse events. These include the potential for blood clots, which can lead to Venous Thromboembolism (VTE), stroke, or heart attack.

Q: Does Stezza interact with hormonal birth control pills?

Official regulatory guidance provides instructions for switching from other hormonal contraceptives. However, Stezza is not intended to be taken concurrently with other combined hormonal contraceptive pills, patches, or similar hormonal methods.

Q: What if I take supplements or vitamins with Stezza?

Regulatory labels specifically indicate that some herbal medicines, such as St. John's Wort, can interfere with the effectiveness of Stezza. The official product information points to the necessity of reviewing the full list of potential interactions with a healthcare provider.

Q: Is Stezza an option for people with mild liver impairment?

Regulatory documentation formally prohibits the use of Stezza for individuals who have severe liver disease or liver tumors. Official product information emphasizes consultation for any patient with a form of liver disease.

Q: What does the research say about the long-term safety of Stezza?

Long-term safety is monitored through clinical trials and post-marketing surveillance data. Regulatory warnings indicate that risks associated with all Combined Hormonal Contraceptives, such as the potential for Venous Thromboembolism (VTE), must be considered throughout the period of use.

Q: How is Stezza different from a generic version of the same active ingredient?

Stezza is the brand name given by the manufacturer, while the generic name refers to the combination of the active ingredients: nomegestrol acetate and estradiol. Regulatory standards ensure that both the brand-name and generic versions contain the same active medicinal components.

Q: Is it okay to stop taking Stezza suddenly?

Regulatory information provides specific guidance on when and how to discontinue the medication, such as prior to certain surgical procedures. Regulatory guidance specifies that if the medication is stopped with the intent to become pregnant, confirmation of the absence of pregnancy may be warranted before starting the next cycle.

Q: Where can I find the official prescribing information for Stezza?

The official prescribing information, including the Summary of Product Characteristics (SmPC) or the full Package Insert, is publicly available on government-run websites. These include the FDA DailyMed or the European Medicines Agency (EMA) website under the medication's approved name.

Q: Does Stezza require a dose adjustment for people with kidney problems?

Official regulatory information notes that while specific clinical data in patients with kidney problems is limited, kidney impairment is considered unlikely to affect how the body eliminates the active ingredients. No specific dose adjustment is typically mentioned in the labeling for this population.

Q: What is the expected timeline to notice the full benefits of Stezza?

The full contraceptive benefit is established after taking the white active tablets for seven consecutive days. This timeline is based on data provided in official regulatory documents.

Q: Are there any limitations on driving or operating machinery while taking Stezza?

Official regulatory documents state that this medication has no or negligible influence on a person’s ability to drive or use machinery safely.

Q: Has Stezza been approved for use in countries outside the United States?

Yes. The active ingredients in Stezza (nomegestrol acetate and estradiol) are approved and marketed as a Combined Hormonal Contraceptive in numerous countries and regulatory regions, including the European Union.

Q: Can Stezza affect the results of common lab tests?

Yes. Official regulatory labeling indicates that the hormonal components of Stezza can influence the results of some laboratory tests. These include specific tests for adrenal and thyroid function, as well as markers related to lipid and glucose metabolism.

Q: What is the possibility of becoming dependent on Stezza?

The medication is not classified as a controlled substance in regulatory schedules. Official documents therefore do not indicate a potential for physical dependence or abuse related to the use of Stezza.

Q: What should a patient do if the benefits of Stezza seem to lessen over time?

Regulatory guidance describes the necessity of a clinical re-evaluation with a healthcare provider if risk factors associated with use worsen or if new medical conditions appear during the course of treatment. This ensures the continued appropriateness of the medication.

Q: Is Stezza considered safe to use during pregnancy or while breastfeeding?

Official regulatory documentation states this medication is formally contraindicated (must not be used) during pregnancy. Furthermore, use is generally not recommended during breastfeeding because the hormonal components may reduce the quantity and change the composition of breast milk.

How should Stezza be stored and disposed of?

Storage Requirements (Official Labeling)

Scope Item Official Regulatory Requirement
Storage Temperature Store below 30 C (86 F).
Environmental Protection Must be protected from light and moisture.
Prohibited Environments Do not freeze the medicine.
Packaging Keep in the original blister pack until use.
Child Safety Keep out of the sight and reach of children.

Disposal Instructions

Official regulatory documents specify procedures for discarding unused or expired Nomegestrol acetate/Estradiol tablets to prevent environmental contamination.

  • Environmental Restriction: The medication must not be disposed of via wastewater or household refuse because the hormonal active ingredients may have harmful effects on the aquatic environment.
  • Required Procedure: Unused or expired tablets should be returned to a pharmacist or disposed of in another safe way that complies with local requirements for pharmaceutical waste.

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

Equivalent of Stezza found in:

A-Z Index: