Azurette

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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 Azurette

Property Description
Active ingredients Desogestrel and Ethinyl Estradiol
Form Oral contraceptive tablets
Pharmacological class Combined hormonal contraceptive (Progestins and Estrogens)
Common use Birth control (Contraception)
Origin Synthetic

What Type of Contraceptive Pill is Azurette?

Azurette is a prescription medicine classified as a Combined Hormonal Contraceptive (CHC), provided as oral contraceptive tablets. This product is a combination of two distinct types of synthetic hormones, which are administered via the oral route in a structured regimen. Drugs containing Desogestrel and Ethinyl Estradiol are primarily identified for their use in preventing pregnancy. Azurette belongs to the established pharmacological class of Progestins and Estrogens, and its formulation uses a monophasic regimen, which is clinically recognized for providing consistent hormonal support throughout the active pill phase.


Azurette’s Composition: Synthetic Estrogen and Progestin

The active ingredients in Azurette are Desogestrel and Ethinyl Estradiol, which are chemical compounds engineered to mimic the activity of the body’s natural reproductive hormones. Desogestrel serves as the progestin component, while Ethinyl Estradiol provides the estrogen component. The mechanism relies on delivering synthetic versions of hormones to inhibit fertility. These are entirely synthetic hormones, specifically a third-generation progestin combined with a synthetic estrogen. This newer generation of progestin is a key differentiating feature of the formulation. The drug is manufactured as an oral solid dosage form (tablets) using pharmaceutical excipients to ensure stable and precise delivery of the two active ingredients.


What Is the General Purpose of Taking Azurette?

The overall purpose of Azurette is to provide reliable and effective contraception for women of reproductive age. As a daily oral contraceptive tablet, its function is to prevent pregnancy through its primary antiovulatory action—the consistent supply of the synthetic hormones suppresses the release of the egg from the ovary. A typical use scenario involves a patient starting the medication to establish routine, predictable control over her fertility. The high-level benefit of Azurette is to offer a non-surgical, user-controlled method of birth control that is highly effective when used consistently.

Regulatory References

  1. U.S. National Library of Medicine
  2. NIH, National Institute of Child Health and Human Development

What side effects are possible with Azurette?

Possible Side Effects and Safety Information for Azurette

Serious Adverse Reactions and Safety Considerations

The most significant safety warning associated with combined oral contraceptives, including Azurette, relates to the increased risk of thromboembolic disorders (blood clots). These serious events include deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, and myocardial infarction. The risk is substantially higher in women over age 35 who smoke.

Azurette is contraindicated in individuals with a history of or high risk for arterial or venous thrombotic diseases, uncontrolled hypertension, liver tumors or active liver disease, known or suspected estrogen- or progestin-sensitive cancer (e.g., breast cancer), or undiagnosed abnormal uterine bleeding. Use is also restricted with certain Hepatitis C drug combinations (containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir) due to the risk of liver enzyme elevation.

Safety monitoring notes include the requirement to stop the medication if a thrombotic event occurs or at least four weeks before and two weeks after major surgery. Patients with well-controlled hypertension or diabetes require close blood pressure and glucose monitoring.


Common and Less Frequent Adverse Reactions

Commonly reported side effects (occurring in 1% to 10% of users) primarily affect the gastrointestinal and nervous systems and include nausea, headache, abdominal pain, dizziness, and changes in mood or weight. These effects often diminish after the first few cycles of use.

Less common side effects (0.1% to 1%) may involve the skin (rash, acne), gastrointestinal system (vomiting, diarrhea), and psychiatric health (decreased libido, nervousness, fluid retention). Rare reactions include retinal thrombosis, contact lens intolerance, and specific skin conditions like erythema nodosum/multiforme.

Safety data indicate the highest risk of blood clots occurs during the first year of use or when restarting the medication after a break of four weeks or longer.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory profile for an acute overdose of Azurette (Desogestrel/Ethinyl Estradiol) is defined by its documented manifestations and regulator-mandated emergency actions, with a classification based on low acute toxicity.


Documented Overdose Manifestations

Acute ingestion of large doses is associated with specific clinical signs that affect the gastrointestinal and reproductive systems. The documented overdose presentations include nausea and vomiting. Additionally, withdrawal bleeding, or slight vaginal bleeding, is an officially noted manifestation that may occur in females following overdosage. Regulatory documentation specifically notes that no serious ill effects have been reported following the acute ingestion of large doses, including those instances involving young children.

Emergency Actions and Management

Immediate action is required upon suspicion of overdosage. Official guidance mandates that individuals must seek emergency medical attention or contact a Poison Help Line immediately. The management approach is defined as symptomatic and supportive because regulatory information confirms that no specific antidote is known for Azurette overdose. Treatment will be provided based on the patient's individual clinical presentation.

Therapeutic Uses of Azurette

Azurette is a prescription combination oral contraceptive indicated for the prevention of pregnancy in women who choose this method of contraception. It provides a reliable therapeutic option for birth control.

This medication is also utilized to manage certain menstrual-related symptoms in specific clinical scenarios. It can support the regulation of the menstrual cycle, which often helps in managing blood loss and discomfort, potentially contributing to a more predictable experience. Common applications include addressing menstrual cycle irregularity and supporting the reduction of dysmenorrhea (painful menstruation).

For females of reproductive potential, Azurette serves as an established pathway for managing their health goals.


Quick Fact: Symptom Management Support
Azurette may support the control of menstrual discomfort and contribute to increased menstrual cycle regularity.

Regulatory References

  1. FDA prescribing information guidance

Eligibility and Restrictions for Use

Azurette is officially indicated for use by females of reproductive potential who are post-menarche for the prevention of pregnancy. The regulatory profile defines specific, absolute constraints for eligibility.

Eligibility Status Official Rule Highlights
Contraindicated Females over 35 years old who smoke; current or history of thromboembolic disorders or cerebral/coronary artery disease.
Contraindicated Known or suspected breast carcinoma or other estrogen-dependent cancers; pregnancy (known or suspected); or severe liver disease (including tumors).
Contraindicated Females with uncontrolled hypertension or diabetes with vascular involvement.

Age and Physiological Limitations

The medicine is not recommended for use in females pre-menarche (before the start of menstruation). Use is not indicated for older adults, as specific studies have not been performed in the geriatric population. Furthermore, Azurette is not recommended during breastfeeding due to potential effects on milk production and is restricted to initiation no earlier than four weeks after delivery for non-nursing mothers.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Contraindicated Combinations

The co-administration of Azurette is formally contraindicated with certain Hepatitis C Virus (HCV) drug regimens, specifically those containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. This prohibition is due to the potential for significant liver enzyme elevations (ALT) documented in regulatory information. Co-administration with glecaprevir/pibrentasvir is also strongly cautioned against.

Interactions Reducing Effectiveness

Many medicines, particularly certain Anticonvulsants (e.g., phenytoin, carbamazepine, phenobarbital) and antibiotics like Rifampin, are enzyme inducers. Their concurrent use with Azurette can trigger a pharmacokinetic interaction that reduces the plasma concentrations of the contraceptive hormones (Desogestrel and Ethinyl Estradiol), potentially diminishing its effectiveness. The herbal supplement St. John's wort is also cited as causing this effect.

Altered Exposure of Other Drugs

Azurette may alter the clearance of other co-administered medicinal products. For example, the use of combined hormonal contraceptives substantially reduces the plasma concentration of lamotrigine due to enhanced glucuronidation, an outcome that is officially described as clinically significant.

Procedural and Timing Restrictions

Regulatory documentation requires the mandatory discontinuation of Azurette at least four weeks prior to and for two weeks following major elective surgery or during prolonged periods of immobilization. Furthermore, to prevent reduced absorption of the hormonal components, Azurette must be administered at least 4 hours before the dose of the bile acid sequestrant Colesevelam.

Mechanism of Action

Central Control of Reproductive Hormones

The mechanism of Azurette is primarily defined by the actions of its components, etonogestrel (progestin) and ethinyl estradiol (estrogen), as agonists on their respective nuclear receptors. The steady presence of these steroids triggers a sustained negative feedback signal directed toward the Hypothalamic-Pituitary-Ovarian (HPO) axis . This centrally suppresses the release of pituitary FSH and LH, resulting in the physiological consequence of anovulation (the failure to release an egg).


Peripheral Structural and Systemic Modulation

Secondary mechanisms include local changes mediated by the progestin component, which cause the endometrium to become thin and undeveloped, altering its state of receptivity. Concurrently, it increases the viscosity and quantity of cervical mucus, producing a thickened substance with increased resistance to sperm passage. Additionally, the ethinyl estradiol component induces hepatic protein synthesis, significantly raising the systemic level of Sex Hormone-Binding Globulin (SHBG), which modulates the amount of free circulating sex hormones.

Dosage and Administration Information

How Azurette is Used: Administration Guidelines

Azurette is a prescription medication administered exclusively by the oral route. Its usage follows a continuous, sequential, 28-day cycle that requires strict adherence to a daily schedule. The fundamental instruction is to take one tablet daily at approximately the same time each day to ensure the interval between doses does not exceed 24 hours.


Dosing Structure and Schedule

The full regimen is supplied in a dispenser pack containing tablets of three distinct types that must be taken in sequential order. The pack includes 21 active combination tablets (with 0.15 mg desogestrel and 0.02 mg ethinyl estradiol), followed by 2 inactive tablets, and then 5 low-dose active tablets (with 0.01 mg ethinyl estradiol).

The guidelines for starting the regimen permit two primary protocols:

  • Day 1 Start: The first active tablet is taken on the first day of the patient’s menstrual flow.
  • Sunday Start: The first active tablet is taken on the first Sunday after the start of the menstrual flow.

Procedural Constraints

If the Sunday Start method is chosen for initiation, the use of a nonhormonal back-up method of contraception is required for the first seven consecutive days of active tablet intake.

Administration continues uninterrupted; upon finishing the last tablet of a 28-day pack, a new pack must be started immediately the following day. The same standard adult dosing schedule (one tablet daily) is used for postpubertal adolescents. Specific procedural guidance exists for managing situations where active tablets are missed.

Recent Clinical Evidence

Azurette: Recent Clinical Evidence

This section provides a summary of the clinical research conducted on Azurette (Desogestrel and Ethinyl Estradiol), focusing on the types of studies performed and the outcomes researchers chose to measure. This is a descriptive overview and does not offer clinical advice or personal treatment recommendations.


Evidence for use in Contraception (Prevention of Pregnancy)

Pivotal Phase 3 clinical trials were studied for contraceptive efficacy in healthy women of reproductive age, generally spanning 18 to 40 years old. Research examined standardized metrics such as the Pearl Index and Life Table Pregnancy Rate, along with monitoring of Cycle Control and Bleeding Patterns. Findings describe patterns observed under conditions of “typical use,” where the observed outcome is highly dependent on a patient’s consistent adherence to the daily regimen.


Evidence for use in Managing Menstrual-Related Symptoms

Research has explored the use of this formulation in patients with primary dysmenorrhea (painful menstruation). Studies utilized Randomized, Double-Blind, Placebo-Controlled Exploratory designs in younger women. The research examined outcomes related to physical discomfort, including measurements of Menstrual Pain Severity and Cramping scores, typically over four consecutive 28-day cycles. Findings describe patterns observed in pain score measurements, and this research contributes to the broader evidence landscape for combined hormonal contraceptives.


Research Gaps and Areas of Uncertainty

The evidence supporting contraception is primarily derived from clinical trials of high methodological rigor. However, data are still emerging for symptom management, as these studies were often exploratory and had modest sample sizes. Long-term outcomes and multi-year patterns rely heavily on epidemiological research and post-marketing surveillance, as initial randomized trials utilized short-to-intermediate-term follow-up (up to 18 cycles). Data for certain groups remain insufficient, and subgroup findings are uncertain for specialized populations such as those with specific comorbidities.

Key Studies & References

  1. Azurette Prescribing Information (DailyMed)
  2. Desogestrel and Ethinyl Estradiol Drug Information (MedlinePlus/NLM)

Frequently Asked Questions (FAQ)

Common questions about Azurette (FAQ)


Q: What conditions besides preventing pregnancy might Azurette be prescribed for?

Azurette is primarily indicated for the prevention of pregnancy. Official regulatory information specifies this primary indication. Studies have explored its use in managing painful menstruation (primary dysmenorrhea), but this is not listed as an official indication.


Q: How does the hormone dose in Azurette compare to other common birth control pills?

The ethinyl estradiol component is considered a low dose compared to other combined oral contraceptives. The official labeling describes the specific dose amounts of the two hormones: the progestin desogestrel and the estrogen ethinyl estradiol.


Q: Is Azurette considered a 'low-dose' birth control pill?

The official product information lists the specific dose of ethinyl estradiol, which is often clinically regarded as a low dose. The formulation is primarily designed for effective contraception.


Q: What is the typical timeframe before Azurette is fully effective?

Official prescribing information states that if the regimen is started using the Sunday Start method, a nonhormonal back-up method of contraception is required for the first seven consecutive days of active tablet use. This back-up method is necessary to provide protection during the initial time period.


Q: Is it normal to experience spotting or breakthrough bleeding while taking Azurette?

Yes, breakthrough bleeding and spotting are commonly reported adverse reactions, especially during the first few months. This occurs as the body adjusts to the medication. These effects often lessen within the first few cycles of use, but may persist for some individuals.


Q: Why might a person's period become lighter or stop completely on Azurette?

According to regulatory documentation, the consistent use of the medication may be associated with a change in menstrual flow, often resulting in lighter periods. Some users may also experience absent or missed menstrual periods (amenorrhea). This should be discussed with a healthcare provider to confirm correct use and exclude other causes.


Q: How long does it typically take for a regular menstrual cycle to return after discontinuing Azurette?

Regulatory information notes that temporary infertility (a delay in returning to a regular cycle) is a possible effect upon discontinuation. The return of a regular menstrual cycle varies by individual.


Q: Is there a link between taking Azurette and developing gallbladder problems?

Official warnings indicate that using combined hormonal contraceptives may increase the risk for gallbladder disease. This risk should be considered before starting the medication.


Q: Can Azurette increase the risk of developing migraine headaches?

Official product information lists headache as a common side effect and migraine as an uncommon adverse reaction. Patients should discuss any new or worsening migraines with a healthcare provider, as certain types of migraines are contraindications to combined hormonal contraceptives.


Q: Are changes in mood or libido common side effects of Azurette?

Official data classifies changes in mood as a common side effect (1% to 10% of users). Decreased libido (sex drive) is listed as a less common side effect, affecting between 0.1% and 1% of users.


Q: Does Azurette cause weight gain, or is that a common misconception?

Official regulatory documents list increased weight as a common side effect, affecting 1% to 10% of users. Fluid retention is also listed as a potential, less common, metabolic side effect.


Q: Is it possible for Azurette to cause an increase in acne or help clear it up?

Acne is listed as a less common adverse reaction, affecting less than 1% of users, in official product information. Regulatory documents do not address a benefit regarding the clearing of existing acne.


Q: Is the brand name Mircette the same drug as Azurette?

Azurette and Mircette are different brand names for products that contain the same generic active ingredients: desogestrel and ethinyl estradiol in a sequential regimen. They contain the same active ingredients in the same doses.


Q: How does Azurette compare to other generic versions like Kariva?

Azurette is a brand name for a product containing the generic combination of desogestrel and ethinyl estradiol. Regulatory bodies recognize it as chemically equivalent to other versions, such as Kariva, meaning they contain the same active ingredients in the same doses.


Q: Can Azurette worsen existing conditions like fluid retention or high blood pressure?

The medication is contraindicated in individuals with uncontrolled high blood pressure. Official warnings state that patients with well-controlled hypertension or those with a history of fluid retention may require close monitoring, as the medication could potentially affect these conditions.


Q: Why do some Azurette packs include 'reminder' or inactive pills?

The 28-day dispenser pack includes inactive tablets and low-dose active tablets at the end of the cycle. This structured schedule is designed for continuous, sequential daily administration, which helps establish and maintain the routine necessary for effective contraception.


Q: How long does it usually take for common side effects like breast tenderness to subside?

Official safety data indicates that common side effects, such as breast tenderness, often lessen after the first few cycles of use. This is the typical adjustment period for the body to respond to the new hormonal levels.


Q: Can Azurette cause dark patches on the skin (melasma), and how can this be managed?

Melasma (dark patches on the skin) is a possible side effect that may persist even after the medication is stopped. Regulatory documents suggest that patients should limit their exposure to the sun and artificial UV light while using Azurette.


Q: Is it normal to have a small amount of bleeding during the week of the inactive pills?

Yes, the bleeding that typically occurs during the week of the inactive or low-dose tablets is the expected 'withdrawal bleeding.' This event is a normal part of the regimen and indicates that the hormonal cycle is proceeding as intended.


Q: Can alcohol consumption affect the safety or effectiveness of Azurette?

Although not a formal contraindication, official information suggests that oral contraceptives may increase the central nervous system effects and blood levels of ethanol (alcohol). Patients should use caution when combining the two.


Q: Are there any special considerations for people with diabetes when taking Azurette?

Yes, official warnings advise that patients with diabetes (including those with vascular involvement) require close glucose monitoring. The medication may interfere with blood glucose control.


Q: What happens if a woman has a personal or family history of blood clots; can she still use Azurette?

Azurette is formally contraindicated in individuals with a current or history of arterial or venous thromboembolic disorders (blood clots). The prescribing information advises healthcare providers to consider risk factors, which include certain family history factors.


Q: How does the biphasic nature of Azurette influence its mechanism of action?

Regulatory documents classify Azurette as a monophasic regimen for the first 21 days of active hormone tablets, meaning the active dose remains consistent. Therefore, it is not classified as a true biphasic pill, as the only dose change occurs in the last 7 tablets of the 28-day cycle.


Q: Can Azurette affect a person's ability to wear contact lenses comfortably?

Contact lens intolerance is listed as a rare adverse reaction in official safety data. This involves difficulty or discomfort when wearing contact lenses. If this occurs, it should be discussed with a healthcare provider.


Q: If side effects like nausea persist after the first few months, is that considered normal?

Common side effects, including nausea, often lessen after the first few cycles. If symptoms persist or worsen beyond the initial months, it is important to have the symptoms evaluated by a healthcare provider.


Q: Does Azurette affect the outcome if a person accidentally takes it while already pregnant?

Azurette is contraindicated in known or suspected pregnancy. However, official information notes that studies have failed to reveal an increased risk of birth defects in infants whose mothers inadvertently used oral contraceptives early in pregnancy.


Q: What happens to fertility after a person stops taking Azurette?

Regulatory information notes that temporary infertility (a delay in returning to a regular cycle) is a possible effect following discontinuation. The return of a person's ability to become pregnant after stopping the medication is subject to individual variability.

How should Azurette be stored and disposed of?

How to Store and Dispose of Azurette?

The storage and disposal of Azurette must strictly adhere to regulatory guidelines to maintain its stability and ensure public safety.

Storage/Handling Requirement Official Constraint
Temperature Range Store at Controlled Room Temperature, 20 C to 25 C (68 F to 77 F). Brief excursions are permitted between 15 C and 30 C.
Protection Protect the tablets from excess heat and moisture; do not freeze the product.
Packaging Rule Keep the medicine in its original container and ensure the container is tightly closed.
Child Safety Must be stored out of the sight and reach of children.

Disposal Instructions:

Unused or expired Azurette should be disposed of through an established drug take-back program. To minimize environmental release of the hormonal compounds, do not flush the tablets down a toilet or pour them into a drain. Disposal must comply with official environmental protection requirements.

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

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