Reginon

Quick links to important sections

Reginon

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 Reginon

Quick Facts

Property Description
Active ingredient Ethinyl Estradiol, Gestodene
Form Oral Contraceptive Tablet
Pharmacological class Combined Hormonal Contraceptive (CHC)
Common use Pregnancy Prevention
Origin Synthetic Hormonal Compound

Reginon is a prescription-only medicinal product, distinguished as a Combined Oral Contraceptive (COC) designed for highly reliable Pregnancy Prevention in Women of Reproductive Age. It is a Synthetic Hormonal Compound delivered as an Oral Contraceptive Tablet, officially categorized as a Combined Hormonal Contraceptive (CHC). This class is clinically recognized for providing systemic hormonal management.

Composition and Classification of Reginon

Reginon is a Combination Product containing two key synthetic hormonal components: the estrogen Ethinyl Estradiol and the progestin Gestodene. Gestodene is specifically identified as a potent, synthetic Third-Generation Progestin, a feature that differentiates this formulation from older COCs containing first or second-generation progestins. The combination product utilizes a modern progestin alongside the standardized estrogen, offering a contemporary approach to contraception. The drug is manufactured into a Tablet for Oral administration. This specific blend is frequently utilized, with similar formulations marketed under brands like Femoden.

The Monophasic Approach to Contraceptive Efficacy

Reginon is formally a Monophasic Oral Contraceptive, meaning the daily concentration of Ethinyl Estradiol and Gestodene remains consistent throughout every active tablet. This fixed-dose delivery is integral to its function as an Anti-ovulatory Agent. By consistently providing this hormonal signal, the drug creates a stable hormonal environment, which contributes to achieving high Contraceptive Efficacy. This structured approach is typically employed by women seeking reliable, predictable Regulation of Menstrual Cycle patterns alongside their primary goal of preventing pregnancy.

What side effects are possible with Reginon?

Possible Side Effects and Safety Information

Official regulatory documentation classifies the possible side effects of Ethinyl Estradiol/Gestodene (Reginon) by frequency and the body system affected. The overall safety profile is structured around the assessment of rare, serious risks and more common, expected adverse reactions.

Serious Adverse Reactions

Government regulatory agencies specify that the most significant documented risks relate to Thromboembolic Events, encompassing both Venous Thromboembolism (VTE), such as Deep Venous Thrombosis (DVT) and Pulmonary Embolism (PE), and Arterial Thromboembolism (ATE), which includes Myocardial Infarction and Stroke. Additionally, the development of Liver Tumours (benign or malignant) and severe Jaundice are documented serious safety considerations. The risk of VTE is specifically noted to be highest during the first year of use or upon restarting treatment after a break of four or more weeks.

Common and System-Based Adverse Reactions

Adverse effects listed as frequently observed or categorized by System-Organ Class (SOC) include:

  • Gastrointestinal Disorders: Nausea and Vomiting.
  • Reproductive and Breast Disorders: Breast tenderness (Mastodynia), along with Breakthrough Bleeding or Spotting, which are more commonly experienced during the initial treatment cycles.
  • Nervous System Disorders: Headache and Migraine.
  • Other: Fluid retention (Edema) and skin discoloration (Chloasma).

Safety Constraints and Considerations

Regulatory labeling notes specific safety restrictions. The medicine is generally not recommended for smokers over 35 years of age due to increased cardiovascular risk. It is contraindicated in patients with a history of or predisposition to thromboembolism, severe hepatic disease, or known estrogen-dependent malignancies, such as Breast Cancer. The onset of significant Hypertension or Jaundice requires regulatory discontinuation of the medicine.

Overdose and Emergency Response

Overdose and When to Seek Help

Regulatory documentation indicates that overdose with combined oral contraceptives, such as Reginon (Ethinyl Estradiol/Gestodene), is not likely to be life-threatening and is generally associated with a low risk of serious harmful effects. Due to this low acute toxicity profile, no specific antidote is known.

Documented Manifestations

The most frequently cited clinical manifestations of overdose are generally mild and transient:

Manifestation Category Documented Presentation
Gastrointestinal Nausea and Vomiting
Genitourinary Withdrawal bleeding (Vaginal bleeding)
General Breast tenderness, Headache, Drowsiness

In young girls (before puberty), the manifestation may specifically involve slight vaginal bleeding. Treatment for overdose is strictly symptomatic and supportive.

Required Emergency Actions

Immediate medical attention is necessary for any known or suspected overdose. Regulators mandate that individuals must seek immediate medical help and contact a Poison Control center for guidance. Urgent medical attention is also required if severe symptoms develop (e.g., signs of a thromboembolic event) or if the overdose was deliberate. Medical personnel will measure and monitor the person’s vital signs as part of the supportive management.

Therapeutic Uses of Reginon

What Reginon Treats: Main Uses and Benefits

Reginon (Ethinyl Estradiol/Gestodene) is commonly used for providing reliable birth control, while also offering relevant support for managing specific hormone-related conditions and symptoms in women of reproductive age.

The primary therapeutic areas include pregnancy prevention, as well as providing supportive relief in conditions involving disruptive menstrual cycles, painful menstruation (Dysmenorrhea), and hormone-related acne. The core benefit is providing consistent hormonal stability, which assists patients with maintaining a sense of stability in their reproductive planning.

The medication is applied in addressing symptoms that interfere with daily functioning, particularly those related to heightened physiological activity. For patients managing these issues, it is considered relevant for easing symptoms like heavy bleeding, intense cramping, and premenstrual distress.

“The primary goal of the medication is reliable conception prevention, but it may be part of symptomatic management that helps patients cope more steadily with symptom fluctuations related to their monthly cycle.”


Quick Fact: Relief for Cyclical Discomfort
Symptom Clusters Addressed Irregular timing, painful cramping, excessive bleeding, and hormone-related skin issues.
Patient Benefit Contributes to easing the overall symptom load and establishing a more predictable monthly pattern.

Stabilizing Irregular and Painful Cycles

The treatment may assist with maintaining a more predictable, generally lighter, and less painful monthly pattern. This contributes to easing the overall symptom load and supports general well-being during symptomatic periods. The medication is also commonly used to help with improvement of persistent hormonal acne, which assists with maintaining functional stability.

Regulatory References

  1. NIH MedlinePlus overview of Oral Contraceptives

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Reginon

The following rules for Reginon (Ethinyl Estradiol/Gestodene), a Combined Oral Contraceptive, are based strictly on official government regulatory documents.

Eligibility scope
Populations for whom use is allowed: Women of reproductive age (post-menarcheal adolescents and adults) seeking pregnancy prevention.
Populations for whom use is not recommended: Lactating women (breastfeeding); use should be deferred until the child is weaned.

Contraindications and Restrictions
Contraindicated Populations: Patients with a current or history of Venous or Arterial Thromboembolism (VTE/ATE, e.g., DVT, PE, stroke, or heart attack). This includes those with known thrombophilias.
Hormone/Disease Restrictions: Contraindicated in cases of known or suspected breast cancer or other estrogen-dependent neoplasia, and in patients with severe active hepatic disease or liver tumours.
Age and Comorbidity Rules: Contraindicated in women over 35 years of age who smoke heavily (over 15 cigarettes per day). Also contraindicated in cases of severe hypertension or diabetes with vascular symptoms.
Other Prohibitions: Contraindicated during known or suspected pregnancy, with a history of migraine with aura, and if undiagnosed abnormal uterine bleeding is present.

Connection to the overall eligibility profile: Official regulatory documents strictly define the eligible population as women of reproductive age and establish mandatory contraindications that prohibit its use based on high vascular risk, the presence of specific hormone-sensitive cancers, or severe hepatic disease. Use is also restricted by combining lifestyle factors like heavy smoking with advanced age.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official regulatory profile for Reginon defines specific interaction patterns with other medicinal products, primarily based on pharmacokinetic changes and formal restrictions.

Prohibited Combinations and Exposure Risks

Co-administration with Hepatitis C combination products containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, is a formal contraindication. This restriction is documented due to the risk of significant elevations in liver enzymes.

Interaction with hepatic enzyme-inducing drugs is a central feature of the profile. Substances such as Rifampin, Griseofulvin, and the herbal product St. John's Wort are documented to reduce the contraceptive hormones’ plasma exposure. This results from accelerated metabolism via enzyme induction, which creates a documented risk of decreased contraceptive efficacy.

Effects on Other Medicines

Reginon is also documented to alter the systemic exposure of certain co-administered medicines. The medicine can increase the clearance of specific drugs metabolized through glucuronidation (e.g., Lamotrigine), leading to a reduction in their plasma concentration.

Additionally, Reginon increases the serum concentration of proteins like Thyroid-Binding Globulin. This effect is formally documented to alter the results of certain laboratory tests and may influence the required dosage of co-administered Thyroid Hormone replacement therapy. The official interaction profile does not typically specify timing-based separation rules.

Mechanism of Action

Reginon acts as a mixed serotonin and dopamine receptor modulator, exerting both central and peripheral effects. Its primary biological targets are Dopamine D2 receptors and Serotonin 5-HT4 receptors.

Molecular Interactions

It functions as a competitive antagonist at central and peripheral dopamine D2 receptors and an agonist at peripheral serotonin 5-HT4 receptors. At higher concentrations, it also displays antagonist activity at serotonin 5-HT3 receptors.

Intracellular and Systemic Cascades

Central D2 receptor antagonism occurs selectively in the chemoreceptor trigger zone of the area postrema, inhibiting dopaminergic signaling that triggers the emetic reflex. Peripherally, 5-HT4 agonism on enteric cholinergic neurons enhances the presynaptic release of acetylcholine within the myenteric plexus. This cholinergic enhancement increases the resting tone of the lower esophageal sphincter and promotes coordinated smooth muscle contractions across the stomach and small intestine. The resulting system-level physiological modulation is an acceleration of gastric emptying and increased transit time through the upper gastrointestinal tract, alongside inhibition of the central vomiting pathway.

Dosage and Administration Information

Reginon (Ethinyl Estradiol/Gestodene) is administered orally as a monophasic tablet containing a fixed daily dose of Gestodene 75 mcg and Ethinyl Estradiol 30 mcg. The medicine is used in a cyclic regimen where one active tablet is taken once daily, ideally at approximately the same time every day. This consistent daily timing is part of the standard usage pattern.

A standard course consists of 21 consecutive days of active tablets, followed by a 7-day tablet-free interval or the use of 7 inactive/placebo tablets. The tablets must be swallowed whole with a little liquid and taken sequentially as indicated on the pack. To begin treatment, the first active tablet is typically taken on the first day of menstrual bleeding. If started later than Day 1, a non-hormonal back-up method is used for the first seven consecutive days of active tablet intake.

Administration Constraints and Missing a Tablet

The approach for a missed active tablet depends on the time elapsed. If the tablet is missed by less than 12 hours from the usual time, it is taken immediately, and the regular schedule resumed. If the tablet is missed by more than 12 hours, protection may be reduced; the last forgotten tablet is taken immediately, and a barrier method is used for the following seven days. In terms of specific populations, the medicine is not recommended for use in lactating women. For non-lactating women post-delivery, the regimen is generally commenced 21 to 28 days postpartum.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Reginon


Evidence for Use in Pregnancy Prevention (Contraception)

Research has explored the role of Ethinyl Estradiol/Gestodene in conception prevention. Randomized controlled trials (RCTs) have been used in research exploring outcomes over defined periods, typically spanning six to twelve monthly cycles. These trials primarily monitored the occurrence of pregnancy, measured using standardized tools like the Pearl Index, and research examined physiological outcomes related to ovarian activity, which is monitored for its role in conception.

Studies included healthy women of reproductive age who were new to hormonal contraception or who were switching from a different product. Findings describe patterns observed in the studies, providing data used in the regulatory assessment of this class of medication.


Evidence for Symptomatic Management of Menstrual Cycles

Research explored the pattern of menstrual symptoms, including pain and bleeding, through trials that applied in studies examining patient-reported experiences. Painful menstruation (Dysmenorrhea) was evaluated in research that studied women of reproductive age experiencing this condition. Study reports describe measurements collected during the study period related to the severity of pain.

Research monitored short-term changes in the requirement for additional pain medication. However, follow-up durations were limited in many interventional trials for symptom patterns, often spanning only three to six months, meaning there is limited information on the long-term pattern of symptoms.


Evidence for Symptomatic Management of Hormone-Related Acne

This specific hormonal combination was studied for its relation to outcomes in women with mild to moderate Acne Vulgaris. Researchers monitored changes in the number of acne lesions over defined time intervals, often up to 12 cycles. Study reports describe the patterns of symptom measurement in observed populations, including global severity ratings as assessed by clinicians.


Evidence Gaps and Areas of Uncertainty

While studies for contraception were intermediate-term, long-term effects are not fully established through randomized trials alone. Evidence quality varies across studies, particularly those focused on subjective symptomatic endpoints where smaller sample sizes were common. Research describes group patterns, but study results reflect the specific conditions under which they were conducted, and findings do not determine whether an individual will respond similarly.

Key Studies & References MedlinePlus: Ethinyl Estradiol and Gestodene

Frequently Asked Questions (FAQ)

Common questions about Reginon (FAQ)


Q: How soon should I expect Reginon to start working?

According to the official product information, contraceptive protection begins to apply immediately if the first active tablet is started on the very first day of the menstrual cycle. If the medicine is started later than Day 1, regulatory documents indicate that protection begins after the first seven consecutive days of correctly taking the active tablets.


Q: Is Reginon safe for people over the age of 65?

The official prescribing information states the medicine is intended for use by women of reproductive age. Use in elderly women is generally not within the scope of its primary indication for pregnancy prevention.


Q: How is Reginon different from other similar medicines?

Reginon is classified as a Combined Oral Contraceptive (COC). It contains two synthetic hormones: Ethinyl Estradiol and the progestin component, which is specifically a Third-Generation Progestin called Gestodene. The medicine contains this specific combination of hormones.


Q: Do the side effects of Reginon usually lessen over time?

Official information indicates that common adverse reactions like breakthrough bleeding (spotting) and breast tenderness are typically observed more often during the initial treatment cycles, usually the first three months. This pattern suggests that these particular symptoms may become less frequent or severe after the initial adjustment period.


Q: Is Reginon meant to be a short-term or long-term treatment?

The medicine is intended for ongoing use for the purpose of contraception. While studies for this purpose have spanned intermediate periods (up to 12 cycles), official documents note that long-term evidence for some symptomatic effects is limited by follow-up duration.


Q: Is Reginon used to cure the condition or just manage the symptoms?

Regulatory documents define the medicine's role as Pregnancy Prevention and the symptomatic management of conditions like Dysmenorrhea. It functions to regulate physiological processes or manage symptoms, and is not indicated as a cure for underlying conditions.


Q: Does taking Reginon make people feel better or just stop the condition from getting worse?

In its use for symptomatic management (such as for Acne or painful menstruation), studies examined patient-reported severity, which focused on the positive change and improvement of symptoms. Research focused on demonstrating that symptomatic outcomes were better than those achieved without the medicine.


Q: Does Reginon interact with alcohol or wine?

Official regulatory summaries for the estrogen component (Ethinyl Estradiol) of this class of medicine may indicate a minor interaction with alcohol (ethanol). Official documentation should be consulted for the most accurate guidance on consumption.


Q: Are there any specific foods that should be avoided while taking Reginon?

Regulatory information for the hormonal component of this medicine often advises monitoring or avoiding the consumption of grapefruit or grapefruit juice. This recommendation is based on the possibility that grapefruit may influence the concentration of hormones in the body.


Q: Does Reginon have a generic or cheaper version available?

Formulations containing the active ingredients Gestodene and Ethinyl Estradiol are marketed globally under several different brand names. This global availability implies that generic equivalents may exist in the markets where these specific formulations are approved.


Q: Is Reginon known to cause unexpected weight changes?

Weight Gain is listed in the official regulatory documents as a commonly reported adverse reaction associated with this class of medicine. This effect is tracked as part of the overall safety profile.


Q: Is Reginon considered a controlled substance or addictive?

Reginon is a prescription-only medicine that contains synthetic hormones. It is not designated as a controlled substance by government regulatory bodies.


Q: Can Reginon cause problems with insomnia or drowsiness?

While official documents list central nervous system-related effects like headache, migraine, and nervousness, insomnia or drowsiness are not specifically listed as common adverse reactions for Reginon.


Q: Where can I find the official patient information leaflet for Reginon?

The official patient information leaflet (PIL) or patient counseling information is generally made available to the public. This authorized document is typically made available through governmental drug information databases, such as those maintained by the FDA or the EMA.


Q: What are the typical signs or symptoms of taking too much Reginon?

Official regulatory documents indicate that the symptoms reported following overdosage of oral contraceptives typically include general issues like Nausea and Vomiting. Withdrawal bleeding (a type of bleeding that is not menstrual) may also occur in females.


Q: What medical monitoring or tests might be required before starting Reginon?

Official guidelines advise that a Blood Pressure Check should be conducted before starting Reginon, and checked periodically during treatment. Furthermore, reviewing a patient's medical history, especially for risk factors related to blood clots (thromboembolism), is included as a required step in regulatory documents.


Q: Can Reginon cause changes in my mood or anxiety levels?

Regulatory documents for this class of medicine list Mood Changes, Mood Disorders, and Nervousness as reported adverse reactions. These effects are part of the known psychiatric adverse reactions associated with the use of the medicine.


Q: How long does it take for Reginon to be fully eliminated from the body?

The official pharmacokinetic data indicates the elimination half-life of the Gestodene component is reported to be approximately 12 to 15 hours.


Q: Are there specific warnings about Reginon for people with severe kidney issues?

While warnings primarily focus on the liver, official documents note that this class of medicine can cause Fluid Retention (Edema). Due to this potential effect, patients with conditions like renal (kidney) dysfunction require special consideration.


Q: Is it normal to feel a bit dizzy when first starting Reginon?

Dizziness is a listed symptom associated with central nervous system side effects, as described in regulatory documents. This symptom is a known effect that is tracked, particularly due to the medicine's established relation to blood pressure changes.

How should Reginon be stored and disposed of?

All prescription medications, including Reginon, must be stored according to the specific instructions provided on the official product label to maintain the drug's quality, strength, and purity. If no specific conditions are stated, the medication should be kept at controlled room temperature.

Storage & Handling Guidelines

  • Temperature & Protection: Store Reginon as instructed, generally away from excessive heat, cold, and moisture. If the label requires it, the product must be stored in the original packaging or carton to protect it from light.
  • Children: Keep all medicines, including Reginon, out of the sight and reach of children to prevent accidental ingestion.
  • Stability: Observe the expiration date on the packaging. Once a sealed container is opened or a product is reconstituted (if applicable), follow the official in-use stability period specified by the manufacturer.

Disposal

To dispose of expired or unwanted Reginon, follow the official guidelines from the FDA or your national health agency. The preferred method for most drugs is a drug take-back program or mail-back envelope. If these options are not readily available and the drug is not on a specific 'flush list,' you should dispose of it in your household trash by mixing it with an undesirable substance (like coffee grounds or kitty litter) and sealing it in a container.

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

Available in countries:

Equivalent of Reginon found in:

A-Z Index: