Cryselle 28

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Cryselle 28

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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 Cryselle 28

Quick Facts

Property Description
Active ingredients Norgestrel and Ethinyl Estradiol
Form Monophasic Tablet (28-day regimen)
Pharmacological class Estrogen/Progestin Combined Contraceptive
Common use Prevention of pregnancy (Contraception)
Origin Synthetic (synthetic steroidal hormones)

What Type of Medicine is Cryselle 28?

Cryselle 28 is a prescription-only medication that functions as a Combined Hormonal Contraceptive (CHC), which belongs to the larger pharmacological class of Estrogen/Progestin combined contraceptives. This preparation is administered via the oral route as a daily tablet and is designated for the prevention of pregnancy in women of reproductive potential.

The product is supplied as a monophasic regimen within a 28-day pack, a specific structure that includes 21 active tablets containing hormones followed by seven inert tablets (placebo pills) to maintain a continuous daily dosing schedule. The use of a monophasic approach, where the hormone levels remain constant across all active tablets, is a distinguishing factor designed to provide predictable hormonal balance.

Synthetic Hormones: Composition and Differentiation

The drug's foundation rests on two synthetic active components: Norgestrel, which serves as a synthetic progestogen, and Ethinyl Estradiol, which functions as a synthetic estrogenic compound. As a combination product, Cryselle is the generic equivalent of the formerly branded product Lo/Ovral, utilizing this widely-studied hormonal formulation. This combination is often clinically recognized for reliably achieving its therapeutic purpose of contraception.

The Overall Purpose of Cryselle 28

The established, overriding purpose of using Cryselle 28 is to achieve reliable, daily contraception. The combination of synthetic estrogen and progestin creates a hormonal state that interrupts the necessary conditions for conception. This system is designed to provide females of reproductive potential with the core benefit of effectively reducing the risk of an unintended pregnancy, offering a non-invasive, daily option for family planning.

Regulatory References

  1. Ethinyl Estradiol and Norgestrel (Oral Contraceptives) - MedlinePlus
  2. CRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL TABLETS) - DailyMed
  3. Cryselle FDA Prescribing Information - DailyMed (Official Label)

What side effects are possible with Cryselle 28?

Possible Side Effects and Safety Information

This section outlines the officially documented adverse reactions and safety-related restrictions for Cryselle 28, based strictly on government regulatory documents.


Serious and Clinically Significant Risks

Use of this medicine is associated with an increased risk of serious thromboembolic events, including deep vein thrombosis (DVT), pulmonary embolism (PE), stroke (ischemic and hemorrhagic), and myocardial infarction (heart attack). The risk of venous thromboembolism (VTE) is highest during the first year of use and when restarting after a four-week or longer hiatus.

Regulatory documents also detail potential for serious issues involving the hepatic system (e.g., rare liver tumors, jaundice) and the ocular system (e.g., retinal vein thrombosis, unexplained loss of vision). These serious events require immediate medical attention and may necessitate discontinuation of the medicine.

Common Adverse Reactions

Adverse reactions that have been commonly reported in association with combined oral contraceptive use include nausea, headache, irregular uterine bleeding, breast tenderness, weight gain, and nervousness.


Safety Restrictions and Contraindications

Use is contraindicated in women with a history of arterial or venous thrombotic diseases, certain cancers (such as known or suspected breast cancer or liver tumors), uncontrolled hypertension, or undiagnosed abnormal uterine bleeding.

Population-Specific Restrictions: The medicine is strictly contraindicated in women over 35 years of age who smoke due to a significantly elevated risk of serious cardiovascular side effects. Additionally, it should not be initiated within four weeks following delivery in non-breastfeeding women.

Interactions: The efficacy of this medicine may be reduced when taken with certain other drugs, such as some anticonvulsants or antibiotics like rifampin. The medicine is also contraindicated for use with specific drug regimens for Hepatitis C.

Overdose and Emergency Response

Overdose and When to Seek Help

This section describes the officially documented manifestations of overdosage and the mandatory emergency actions required by regulatory authorities for Cryselle 28 (Norgestrel and Ethinyl Estradiol).


Documented Overdose Manifestations

Official regulatory labeling indicates that overdosage with combined oral contraceptives, including Cryselle 28, is not associated with documented serious ill effects or life-threatening outcomes. The expected clinical presentation in an overdose situation is generally limited to transient, non-severe symptoms affecting the gastrointestinal and reproductive systems.

Clinical Manifestation System Affected
Nausea Gastrointestinal
Vomiting Gastrointestinal
Vaginal bleeding Reproductive (often withdrawal bleeding)

No specific antidote is explicitly documented for the management of overdosage. Due to the lack of evidence for severe toxicity, treatment is typically supportive and based on the symptoms presented.


Official Emergency Actions Required

Immediate medical attention is officially required upon suspicion of overdosage. Regulatory documents specify that individuals experiencing overdosage must seek emergency medical attention and utilize specific resources for guidance.

Required Action Contact Information
Seek emergency medical attention Contact emergency services immediately.
Call the Poison Help line 1-800-222-1222

These actions are mandatory for all cases of suspected overdosage, ensuring that the required regulatory procedure is followed to assess the individual's condition.

Therapeutic Uses of Cryselle 28

What Cryselle 28 Treats: Main Uses and Benefits

The primary therapeutic application for Cryselle 28 is to provide effective, daily contraception, which is relevant in contexts involving long-term family planning. The medication is generally applied in contexts where continuous symptomatic support is considered relevant.

Managing Menstrual Cycle Symptoms

The medication is commonly used in situations involving certain distressing symptoms across several therapeutic areas. It is generally applied in addressing symptoms related to irregular or unpredictable periods, easing the distressing manifestations of dysmenorrhea (severe, painful cramping), and contributing to easing the overall symptom load of menorrhagia (abnormally heavy menstrual bleeding). Furthermore, it may assist with managing symptoms related to mild-to-moderate acne.


Quick Fact: Relief for Symptom Burden

Symptom Category Therapeutic Benefit
Heavy Bleeding Contributes to easing the overall symptom load.
Painful Cramping Supports patients by easing distressing manifestations.
Cycle Irregularity Assists with maintaining functional stability and predictability.

Regulatory References

  1. NIH DailyMed Drug Information

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Cryselle 28 — Official Regulatory Information

The eligibility profile for Cryselle 28 is defined by strict regulatory criteria, primarily targeting the reduction of serious cardiovascular and thromboembolic risks. The medication is indicated only for females of reproductive potential.


Populations for whom use is Contraindicated

The medicine must not be used by females who are over 35 and smoke. Use is also strictly prohibited in the presence of:

  • A high risk of arterial or venous thrombotic diseases, including a history of deep-vein thrombosis, pulmonary embolism, stroke, or coronary artery disease.
  • Active liver disease (including tumors) or uncontrolled hypertension.
  • Diabetes mellitus with vascular disease or specific types of migraine headaches (e.g., migraine with aura).
  • Current diagnosis of, or history of, breast cancer.
  • Pregnancy or undiagnosed abnormal uterine bleeding.

Age and Condition-Based Restrictions

Age-related eligibility rules specify that the product is not indicated for use before menarche or in elderly women. Postpartum use is restricted, with initiation advised no earlier than 4 weeks after delivery in non-breastfeeding women. The medicine is not recommended for females who are breastfeeding, as it may decrease milk production. Use requires careful monitoring in females with well-controlled hypertension or uncontrolled dyslipidemias.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documents define specific interaction patterns for Cryselle 28 (Norgestrel and Ethinyl Estradiol), primarily concerning altered plasma concentrations and contraindicated combinations.

Contraindicated Combinations

Co-administration with Hepatitis C Virus (HCV) regimens containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, is strictly prohibited due to the potential for significant Alanine Transaminase (ALT) liver enzyme elevations. Oral Tranexamic Acid is also listed as a combination with a severe interaction risk.


Interactions Altering Hormone Exposure

Interaction Type Interacting Substance Examples Official Outcome Description
Decreased Exposure (Risk to Efficacy) Rifampin, certain Anticonvulsants (e.g., Carbamazepine, Phenytoin), St. John's wort These substances are documented to be hepatic enzyme inducers, which accelerates the clearance and decreases the plasma concentration of the contraceptive hormones.
Increased Exposure of Other Drugs Tizanidine, Caffeine Ethinyl Estradiol may inhibit the metabolism of these substances, potentially leading to an increase in their blood levels.

The regulatory profile notes a specific population-based restriction: the combination of Tobacco smoking and age over 35 years is a regulatory contraindication due to significantly increased cardiovascular event risk. Furthermore, severe diarrhea or vomiting are documented non-drug factors that may reduce the absorption of the active ingredients.

Mechanism of Action

Cryselle 28 is a combined hormonal contraceptive consisting of norgestrel (a progestin) and ethinyl estradiol (an estrogen). Its primary pharmacodynamic action targets the hypothalamic-pituitary-ovarian (HPO) axis via negative feedback inhibition.

Ethinyl estradiol and norgestrel function as agonists at their respective intracellular steroid hormone receptors in the pituitary gland and hypothalamus. This agonism modifies gene transcription and subsequent protein synthesis, resulting in decreased secretion of gonadotropin-releasing hormone (GnRH) from the hypothalamus. The reduced GnRH pulsatility leads to a diminished release of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) from the anterior pituitary gland.

The system-level consequence of lowered circulating LH and FSH concentrations is the suppression of ovarian folliculogenesis and ovulation. Furthermore, the progestin component, norgestrel, induces structural and biochemical alterations in the endometrium, resulting in an environment that is unreceptive to implantation. Norgestrel also modulates cervical mucus consistency, increasing its viscosity and impeding sperm transit through the cervical canal.

Dosage and Administration Information

Administration Scope

Route of administration: Oral (taken by mouth), as a daily tablet.

Dosing schedule: The regimen follows a continuous, cyclic 28-day schedule. This sequence involves taking 21 active tablets containing 0.3 mg Norgestrel and 0.03 mg Ethinyl Estradiol, followed immediately by 7 inactive (inert) tablets. One tablet is administered once daily.

Timing in relation to meals (if applicable): Dosing may be taken with or after the evening meal or at bedtime as a measure to minimize the occurrence of nausea.

Preparation requirements (if applicable): None stated; the medication is used as a whole tablet.

Age-group administration rules: Adolescents are administered the same oral daily regimen as adults. Postpartum patients should wait at least 3 to 6 weeks after delivery before initiation, depending on the risk assessment for venous thromboembolism.

Missed-dose rules: If an active tablet is missed, the specific procedural steps detailed in the package insert must be followed, which may include taking two tablets in one day and using a non-hormonal back-up method for at least 7 days to maintain regimen effectiveness.

Special procedural conditions: The tablet must be taken at the same time each day, with intervals not exceeding 24 hours. Initiation can follow a Day 1 Start or Sunday Start protocol, the latter requiring a non-hormonal back-up method for the first seven days. If vomiting or diarrhea occurs within three to four hours of taking an active tablet, another active tablet should be taken immediately.

Instruction Classifications (High-Level)

Administration method type: Oral

Frequency pattern: Daily (Continuous, 28-day cyclic regimen)

Use-context constraints: Requires strict adherence to daily timing and a specific procedural protocol for handling any missed or disrupted doses.

Resulting Procedural Structure

Step sequence:

  • The entire 28-day regimen requires one tablet to be taken orally once a day at the same time every day.
  • The cycle consists of 21 active hormone tablets followed immediately by 7 inactive tablets, with the cycle repeating upon completion of the last tablet in the pack.
  • The first pack is started either on the first day of the menstrual cycle (Day 1 Start) or on the first Sunday after the menstrual cycle begins (Sunday Start).

Connection to the overall use protocol: The instructions establish a standardized, continuous, 28-day cyclic administration for Cryselle 28, where the daily oral intake of a single tablet must adhere to strict timing constraints. This protocol details the required daily dosage, the sequence of active and inactive tablets, and the procedural actions necessary to maintain the integrity of the regimen when doses are disrupted or missed.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Evidence for Use in Contraception (Prevention of Pregnancy)

Research has examined how the use of this product was studied for preventing pregnancy. These studies are typically applied in observational settings evaluating daily-life functioning and often involve large populations to gather data. The research describes the number of pregnancies that was observed in the studied groups over defined time intervals. When used precisely and consistently, the findings describe measured results related to pregnancy prevention in the studies. This evidence contributes to the broader evidence landscape related to planned, ongoing use.

However, certainty remains low if the product is not used exactly as directed, and data show patterns related to changes in observed pregnancy rates in cases of inconsistent use. The results apply only to the populations studied, and it is important to remember that findings describe group patterns, not personal outcomes. Research highlights what is known—that the product was observed under specific, consistent conditions—and what is still uncertain, namely how individual variations in use may influence the measured results.

Research on Menstrual Cycle Symptom Management

Studies also explored how this product can influence the menstrual cycle, particularly in conditions characterized by fluctuating or episodic manifestations. This research was evaluated in trials assessing short-term or episodic symptom patterns and focused on outcomes reflecting daily functioning or activity level, as well as patient-reported outcomes describing perceived discomfort. Clinical research highlights changes measured during the study period related to cycle predictability. Studies monitored how symptoms evolved in the observed populations, and findings indicate patterns related to cycle patterns that were monitored.

What Remains Uncertain About the Research Record

The evidence base highlights several areas where research is ongoing or data are still emerging. For example, the calculated difference between perfect use and typical use results, while observed in some studies, introduces a level of uncertainty that reflects real-world compliance factors. Comparative evidence is lacking for many head-to-head comparisons against the newest hormonal formulations, and sample sizes were modest in some studies focusing on specific non-contraceptive outcomes. This means the evidence quality varies across studies, and the findings help contextualize what is known—and what is still uncertain.

Key Studies & References

  1. DailyMed: Cryselle (norgestrel and ethinyl estradiol) tablet. NIH National Library of Medicine.

Frequently Asked Questions (FAQ)

Common questions about Cryselle 28 (FAQ)


Q: Is Cryselle 28 used for anything other than birth control?

Official regulatory information lists the primary purpose of this medication as the prevention of pregnancy. However, studies that were conducted also examined the product's influence on the menstrual cycle. This included monitoring patterns related to cycle predictability and the management of certain cycle symptoms.


Q: Does Cryselle 28 have a generic version?

Cryselle 28 is itself a generic formulation containing the hormones norgestrel and ethinyl estradiol. Regulatory documentation lists other products containing the same active ingredients and strengths, which are designated as generic equivalents.


Q: How quickly does Cryselle 28 begin to work?

Official administration instructions address the need for regimen integrity when starting. When using the specific 'Sunday Start' protocol, the documentation states that a non-hormonal back-up method is required for the first seven days of use. This is documented to help maintain the regimen's integrity during the initial part of the first cycle.


Q: Can vitamins or supplements interfere with Cryselle 28?

Official regulatory warnings specifically list the herbal supplement St. John's wort as a substance that may accelerate the clearance of the hormones, potentially reducing the contraceptive effectiveness. Information regarding all supplements and potential effects on drug metabolism is best reviewed with a healthcare provider.


Q: Is Cryselle 28 considered a low-dose oral contraceptive?

The active tablets contain a specific dose of ethinyl estradiol. Regulatory classification generally places oral contraceptives containing 35 mu g or less of ethinyl estradiol into the 'low dose' category, and this product falls within that range.


Q: Where can I find the official regulatory information about Cryselle 28?

Authoritative information, including the full prescribing details, can be found on government resources. You can search databases such as the FDA DailyMed and the National Institutes of Health (NIH) MedlinePlus.


Q: Are there studies available about long-term use of Cryselle 28?

Regulatory documents discuss the association between the long-term use of combined oral contraceptives and potential health risks. For example, there is noted information regarding an increased risk of liver cancers in long-term users, often defined as those who have used combined oral contraceptives for more than eight years.


Q: Can Cryselle 28 be used while breastfeeding, according to official information?

The official regulatory profile states that the medication is not recommended for use in females who are breastfeeding. This is because hormonal contraceptives have been documented to potentially decrease milk production and alter its quality.


Q: Is it normal to have spotting during the first few months on Cryselle 28?

The official product labeling lists irregular uterine bleeding as a commonly reported adverse reaction. Regulatory documentation notes that this irregular bleeding, which can include spotting or breakthrough bleeding, tends to be more common during the initial cycles of use as the body adjusts to the hormones.


Q: Why do some patients use Cryselle 28 if they are not sexually active?

While the overarching purpose is pregnancy prevention, clinical research has also evaluated this product's influence on the menstrual cycle. The research includes monitoring patterns related to cycle predictability and changes in the severity of menstrual symptoms for those who need cycle management.


Q: Is Cryselle 28 monophasic?

Cryselle 28 is classified as a monophasic oral contraceptive. This designation means that each of the 21 active tablets contains the exact same constant amount of both the synthetic estrogen and the synthetic progestin hormones.


Q: What does the '28' in Cryselle 28 refer to?

The '28' in the name refers to the structure of the 28-day continuous cyclic regimen. The pack is structured to contain 21 active tablets and 7 inactive (placebo) tablets, which are all taken once daily over the 28-day period.


Q: Is it necessary to use a backup method when starting Cryselle 28?

Official instructions specify that if a patient starts the medication using the Sunday Start protocol, they must use a non-hormonal back-up method for the first seven days. This is a procedural step required to maintain the regimen's integrity during the initial part of the first cycle.


Q: Are there specific dietary restrictions mentioned for people taking Cryselle 28?

Regulatory interaction data indicates that consuming grapefruit juice may lead to an increase in the plasma hormone concentrations. This is due to the juice’s potential effect on the way the body processes the medication.


Q: Can Cryselle 28 affect future fertility?

Regulatory documents generally note that the medication is reversible. However, some women may experience amenorrhea (absence of periods) or oligomenorrhea after discontinuation, particularly if such conditions were present before starting use. The risk of blood clots associated with the product gradually disappears after use is stopped.


Q: Does grapefruit interact with Cryselle 28?

Regulatory interaction data indicates that consuming grapefruit juice may lead to an increase in the plasma hormone concentrations. This is due to the juice’s potential effect on the way the body processes the medication.


Q: Is it common for Cryselle 28 to affect existing skin conditions?

Regulatory documents list acne as an adverse reaction that has been reported. Changes in existing skin conditions or the development of new ones are reported in post-marketing experience and may vary between individuals.


Q: What happens when the placebo pills in Cryselle 28 are taken?

The seven inactive (placebo) tablets are included in the 28-day regimen to help maintain a continuous daily dosing schedule. The withdrawal bleeding (which is similar to a period) typically occurs while these inactive tablets are being taken.


Q: How long does the primary use of Cryselle 28 typically last after discontinuation?

Official warnings note that the increased risk of blood clots and other thromboembolic disease associated with the use of combined oral contraceptives gradually disappears after the use of the product is discontinued.


Q: Are there special considerations for Cryselle 28 use in patients with diabetes?

Regulatory documents state that use is contraindicated in females who have diabetes mellitus with vascular disease. For women with prediabetes or well-controlled diabetes, regulatory warnings mention that careful monitoring of glucose may be required due to the medication’s potential metabolic effects.


Q: Is Cryselle 28 associated with changes in hair growth?

Official adverse reaction reports include patterns of both increased hair growth (hirsutism), especially on the face, and also patterns of loss of hair on the scalp (alopecia) among the documented reactions.


Q: What does regulatory information say about Cryselle 28 and vision changes?

Official warnings describe conditions where the medication may need to be stopped, such as an unexplained loss of vision or a sudden change in vision. Patients are advised to be evaluated immediately for serious conditions like retinal vein thrombosis.


Q: Is Cryselle 28 available without a prescription?

According to official regulatory labeling, this medication is classified as a prescription-only drug. It is only legally available through a valid prescription from a licensed healthcare provider.


Q: Can Cryselle 28 be used by patients with a history of depression?

Regulatory documentation notes that women with a history of depression may require careful observation. The labeling describes that discontinuation may be considered if depression recurs to a serious degree.


Q: Do any herbal remedies commonly interact with Cryselle 28?

Regulatory warnings specifically list the herbal supplement St. John's wort as a substance that may interact. This interaction could accelerate the clearance of the contraceptive hormones, potentially reducing the effectiveness of the product.

How should Cryselle 28 be stored and disposed of?

How to Store and Dispose of Cryselle 28

Storage and disposal requirements for Cryselle (norgestrel and ethinyl estradiol tablets) are officially defined to maintain the stability of the medication and ensure public safety.


Storage Conditions

Cryselle 28 must be stored at a Controlled Room Temperature, specifically between 20 C and 25 C (68 F and 77 F). The product must be stored away from light and moisture. To maintain product integrity, brief exposures between 15 C to 30 C (59 F to 86 F) are permitted. The medicine must also be kept out of the reach of children.

Disposal Instructions

Patients should consult a healthcare professional or pharmacist for instructions on how to properly dispose of any unused or expired Cryselle 28. This ensures the medicine is discarded according to local pharmaceutical waste handling regulations.

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

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