PROGIRON

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Medically reviewed

Laura Arias

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 PROGIRON

Property Description
Active ingredient Progesterone (Natural Micronized)
Form Softgel Capsule and Solution Injectable
Pharmacological class Progestogen / Female Sex Hormone
General Purpose Hormone replacement / Physiological Balancing
Origin Bioidentical
Status Prescription-only (Rx)

What Type of Medicine is PROGIRON?

PROGIRON is classified as a Progestogen medication, whose active ingredient is Progesterone; it functions as a hormone replenisher. It belongs to the high-level pharmacological class of Female Sex Hormones and is universally a single-ingredient product. The medication is clinically recognized for supporting Physiological Balancing in women where progesterone levels are deficient. This Prescription-only pharmaceutical entity acts as a direct agonist on the progesterone receptor (PR) to initiate natural hormonal functions, a mechanism central to its established efficacy.

Is PROGIRON Natural or Synthetic?

The Progesterone within PROGIRON is considered bioidentical and Natural Micronized Progesterone, meaning its molecular structure is chemically identical to the hormone produced endogenously by the human body, a key distinguishing factor from synthetic progestins. The manufacturing process involves micronization, which is supported by pharmacological studies for its ability to overcome the hormone's poor absorption characteristics. The product is supplied in different dosage form(s), including the Softgel Capsule and the Solution Injectable, where the active ingredient is typically suspended in an oil or lipid base/vehicle to maximize systemic absorption. The flexibility across these forms—oral, vaginal, and parenteral routes—is a differentiating feature of this presentation.

What is the General Purpose of PROGIRON?

The general purpose of PROGIRON is to provide foundational hormone replacement, directly supplying the body with necessary progesterone to compensate for low or deficient endogenous levels. By ensuring sufficient hormone availability and receptor activation, the medication helps to establish the appropriate hormonal conditions required for maintaining key bodily functions. This primary goal focuses on delivering the essential physiological support associated with the natural hormone, contributing to overall hormonal balance.

Regulatory References

  1. European Medicines Agency (EMA)
  2. Female Sex Hormone
  3. hormone replacement
  4. Physiological Balancing
  5. agonist

What side effects are possible with PROGIRON?

Possible Side Effects and Safety Information

The safety profile for this medicine is established in regulatory documents, which formally classify potential adverse reactions by the frequency of their occurrence and the body system affected. This provides a structured overview of the documented risks.


Officially Documented Adverse Reactions

Adverse reactions are officially categorized by frequency. Those classified as common (affecting 1 to 10 users in 100) often involve headache, fatigue or lassitude, nausea, abdominal pain, and breast tenderness or pain. The official safety documentation groups these effects into System-Organ Classes such as Nervous System Disorders and Gastrointestinal Disorders.

Reactions categorized as uncommon (affecting 1 to 10 users in 1,000) include dizziness, somnolence (drowsiness), vomiting, and certain skin and subcutaneous tissue disorders like rash or pruritus. The documentation notes that effects like drowsiness and dizziness may be observed more frequently shortly after the administration of the oral capsule form.

Serious Adverse Reactions and Safety Restrictions

Regulatory information lists the risk of serious adverse reactions, including thromboembolic events such as deep vein thrombosis and pulmonary embolism, and the potential for liver dysfunction, specifically cholestatic jaundice.

Safety is formally restricted by official contraindications. The medicine should not be used in individuals with severe hepatic disease, an active history of thromboembolic disorders, or a known or suspected hormone-sensitive malignancy. Additionally, the presence of undiagnosed abnormal genital bleeding represents a safety limitation for its use.

Overdose and Emergency Response

Overdose and When to Seek Help

PROGIRON (progesterone) is administered under the guidance of a healthcare professional, which makes accidental overdose unlikely in a clinical setting. Progesterone has a wide safety margin, and reports of serious complications from overdose are rare. However, exceeding the prescribed dosage may increase the severity or frequency of common side effects, such as drowsiness, dizziness, or localized injection site reactions.

Symptoms of Potential Overdose

While specific progesterone overdose symptoms are generally not well-defined, excessive levels may be linked to intensified side effects. Symptoms that may indicate very high levels or accidental excessive administration include significant drowsiness, marked dizziness or lightheadedness, and excessive fatigue.

When to Seek Immediate Medical Attention

Regardless of the administered dose, certain severe or immediate symptoms warrant emergency medical attention (call your local emergency number or equivalent) as they may indicate a serious adverse reaction or another underlying condition. These include:

Symptom Category Signs to Watch For
Cardiovascular/Neurological Sudden severe headache, slurred speech, sudden partial or complete loss of vision, chest pain, or symptoms of a blood clot (e.g., pain and swelling in an arm or leg).
Allergic Reaction Swelling of the face, tongue, or throat; severe rash, hives, or difficulty breathing.

If you believe you have administered more than the prescribed dose of PROGIRON, contact your doctor, pharmacist, or a poison control center immediately for advice, even if you do not feel unwell. Do not wait for symptoms to develop.

Therapeutic Uses of PROGIRON

Quick Facts

  • Supports the maintenance of pregnancy in specific patient groups.
  • Assists in preparing the lining of the uterus for potential pregnancy.
  • Used as part of certain hormone replacement therapies.
  • May help address menstrual issues related to hormonal balance.

Therapeutic Domains and Actions

PROGIRON is a treatment option that provides support for several gynecological and reproductive conditions. Its primary use involves support for early pregnancy in women who may require additional assistance. This medication helps to prepare the endometrium, which is the lining of the uterus, for the successful establishment of pregnancy.

It is also indicated in managing certain instances of amenorrhea (absence of menstrual periods) in women who have not yet reached menopause, where the condition is linked to a lack of natural hormone production. Additionally, PROGIRON may be used in combination with other agents as part of menopausal hormone therapy to help manage associated symptoms and prevent conditions like endometrial thickening.

Patients should always follow the prescribing healthcare provider's advice. For a detailed review of the approved indications, please consult a healthcare professional.

Regulatory References

  1. NIH MedlinePlus guidance on Progesterone

Eligibility and Restrictions for Use

Eligibility scope

Category Official Regulatory Statement
Populations for whom use is allowed (as stated in label) Adult women indicated for luteal phase support in Assisted Reproductive Technology (ART), or those with hormonal imbalance leading to secondary amenorrhea or abnormal uterine bleeding.
Populations for whom use is not recommended (if applicable) Women who are breastfeeding. Use is also restricted for patients with conditions potentially aggravated by fluid retention, such as epilepsy or cardiac dysfunction.
Populations for whom use is contraindicated Patients with a history of thromboembolic disorders (e.g., DVT, stroke), severe hepatic impairment, undiagnosed vaginal bleeding, or known/suspected breast malignancy. Contraindication also applies to those with known hypersensitivity to any component (e.g., peanut oil).
Age-related eligibility rules Safety and effectiveness have not been established for pediatric or geriatric women (65 years and older); use is not intended for these age groups.
Condition-specific eligibility rules Use in renal dysfunction requires caution and careful monitoring. Use is contraindicated in severe liver disease.
Pregnancy and lactation eligibility status (if explicitly documented) Permitted for early pregnancy support in ART. Not recommended during breastfeeding.
Eligibility-related restrictions Patients with a history of psychic depression or diabetes mellitus should be closely observed.

Eligibility classifications (high-level)

Classification Official Regulatory Wording/Basis
Eligibility severity classification (as defined in official documents) Contraindicated, Not Established, Not Recommended, Caution/Monitoring Required.
Regulatory basis (EMA / FDA / etc.) Official governmental Prescribing Information and Summary of Product Characteristics (SmPC).
Eligibility-context constraints (as defined in official documents) Eligibility is contingent on the absence of severe organ dysfunction and thromboembolic/malignant disease history.

Resulting eligibility structure

  • Use is contraindicated for patients with a history of blood clots, severe liver disease, or hormone-dependent malignancy.
  • The drug is not established for use in pediatric or geriatric populations due to lack of data.
  • Use is permitted only for the specific indication of luteal phase support in ART treatment programs.

Connection to the overall eligibility profile: Regulatory documents define who can and cannot use PROGIRON by formally excluding populations with the highest risk of serious complications, primarily related to cardiovascular events and malignancy. Furthermore, eligibility is limited to adult women in specific clinical contexts where the safety and efficacy profile has been documented and established by government authorities.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile of this progesterone product is primarily defined by the drug's metabolism and its potential for physical interference with specific dosage forms.

Pharmacokinetic Interactions

Progesterone is metabolized in the liver, primarily through the cytochrome P450 3A4 (CYP3A4) enzyme system. Co-administration with other medicines that affect this enzyme can alter the level of progesterone in the body. Close monitoring is advised when using these combinations.

Interacting Substance Category Practical Implication
CYP3A4 Inducers (e.g., Rifampin, Carbamazepine) May increase the elimination of progesterone, potentially decreasing its systemic exposure.
CYP3A4 Inhibitors (e.g., Ketoconazole) May decrease the metabolism of progesterone, potentially leading to an increase in its systemic exposure.

Local Product Interactions

When using the vaginal dosage form, specific constraints are in place to prevent interference with drug release and absorption. Co-administration with other vaginal products is not recommended. This includes products such as antifungal medicines, lubricants, and barrier contraceptives (diaphragms, condoms) that are designed for vaginal use. Patients with renal insufficiency should also be monitored carefully, as progesterone metabolites are mainly eliminated by the kidneys.

Mechanism of Action

The activity is driven by the hormone Progesterone, which operates via a dual-mechanism that influences several physiological systems.

Endometrial Gene Regulation

The primary mechanism involves Progesterone acting as an agonist on intracellular Nuclear Progesterone Receptors ( PR-A and PR-B). This binding initiates the Genomic Pathway by regulating gene transcription within the nucleus. This slow, sustained action mediates the conversion of the uterine lining from a proliferative state into a secretory state through the synthesis of specific proteins and glandular changes.


Central Neurotransmitter Modulation

A second distinct mechanism occurs rapidly in the central nervous system ( CNS) where Progesterone's metabolites act as positive allosteric modulators of the GABA A receptor. This non-genomic action enhances the effect of the inhibitory neurotransmitter GABA, leading to neuronal hyperpolarization and the resulting CNS depressant effect.


Systemic Fluid Balance Influence

The molecule also exhibits a systemic effect by acting as an antagonist at the Mineralocorticoid Receptor ( MR), primarily in the kidneys. By blocking the effects of aldosterone, this mechanism leads to a reduction in sodium and water reabsorption, resulting in natriuresis (increased sodium excretion) and alteration of systemic fluid and electrolyte homeostasis.


Mechanistic Constraints

The core uterine mechanism is constrained by the necessity of prior Estrogen (Estradiol) presence, which is required to upregulate the PRs and make the tissue responsive to Progesterone. The balance between PR-A and PR-B isoforms also dictates the final cellular response.

Dosage and Administration Information

How to use PROGIRON: Official Administration Guidelines

PROGIRON (Progesterone) is administered according to specific routes and cyclic schedules. The medicine is available in both an oral capsule and an injectable solution, which dictate the method of use.


Administration Scope and Regimens

Route of Administration Dosing Schedule Frequency and Duration
Oral Capsule (100 mg, 200 mg) 200 mg once daily for HRT prophylaxis Cyclic: 12 consecutive days per 28-day cycle.
Oral Capsule (400 mg dose) 400 mg once daily for secondary amenorrhea Fixed Course: Daily for 10 days.
Intramuscular (IM) Injection (50 mg/mL solution) 5 mg to 10 mg administered daily Fixed Course: Daily for 6 to 8 consecutive days.

Administration Details

The oral capsule is administered as a single dose, typically at bedtime, for administration consistency. The capsule must be swallowed whole with liquid; if swallowing difficulty is encountered, it should be taken while standing. The solution is strictly for Intramuscular Use Only.

Procedural Rules

Administration is not established for pediatric or geriatric patients, and use requires observation in individuals with hepatic or renal function concerns due to the drug's metabolic and elimination pathways. If a dose is missed, it should be taken as soon as possible, but a double dose must never be taken. For IM regimens used for functional uterine bleeding, treatment must be discontinued if menstrual flow begins during the course. These protocols define the standardized procedural use.

Recent Clinical Evidence

Research evidence / Overview of studies for PROGIRON

Evidence for Use in Assisted Reproductive Technology (ART) and Luteal Support

Research was conducted for this medicine in studies exploring how symptoms change over time for women undergoing treatments like in vitro fertilization (IVF). These efforts primarily involved Randomized Controlled Trials (RCTs) examining infertile women undergoing both fresh and frozen embryo transfer cycles. The outcomes monitored included measurements of live birth rate and clinical pregnancy rate.

Studies reported measurements of these outcomes. Research explored different routes of administration (vaginal, injectable), and the data show patterns related to these approaches. However, research is ongoing regarding the optimal comparison between all available administration routes and specific dosing schedules. Existing studies provide limited insight into the medicine's application across every single modern ovarian stimulation and trigger protocol today, and the results apply only to the populations studied.

Evidence for Use in Managing Pregnancy Risks

Research was evaluated in studies focusing on pregnant women who may face higher risks for certain outcomes, concentrating on conditions involving periods of heightened symptoms. This includes large-scale clinical trials that looked at the incidence of birth before full term and studies involving women who have experienced recurrent pregnancy loss.

Research Focus on Preterm Birth Prevention

This research was evaluated in studies focusing on pregnant women with specific risk factors, such as a prior history of spontaneous preterm birth or a measurable short cervix. Outcomes monitored included the gestational age at delivery, specifically looking at births before 37 and 34 weeks. Some analyses described patterns of lower occurrence of birth before 37 or 34 weeks of gestation in specific subgroups of high-risk women studied, findings that help contextualize how patients reported their experience.

Research Focus on Preventing Pregnancy Loss

Studies for this indication involved large, multicenter Randomized Controlled Trials focusing on women with a history of recurrent pregnancy loss or who presented with vaginal bleeding in the first trimester. Research examined outcomes like the live birth rate. Studies report more consistent patterns in research examining women with specific risk factors, such as those who had experienced three or more previous losses.

The evidence quality varies across studies, and findings were mixed when looking at the overall group of women enrolled. Furthermore, the certainty remains low, and research is ongoing to fully establish the potential long-term effects on the child following exposure during the first trimester.

Key Studies & References Progesterone (NIH MedlinePlus Drug Information)

Frequently Asked Questions (FAQ)

Common questions about PROGIRON (FAQ)


Q: What should I do if I forget to use a scheduled dose of PROGIRON?

The official procedure for a missed oral dose is that the regulatory procedure describes taking the dose as soon as it is remembered. However, if it is almost time for your next scheduled dose, the instruction is that the missed dose is skipped entirely. Regulatory documents state that a double dose must never be taken to make up for a missed dose.


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

Official labeling indicates that progesterone medications can be associated with changes in the results of certain common laboratory tests. This interference may involve analyses such as those that measure blood lipids, coagulation factors (related to clotting), and how the body handles glucose (sugar). Regulatory labeling includes a recommendation that the laboratory or healthcare provider be informed that PROGIRON is being used before any tests are performed.


Q: Can PROGIRON be used by people with a history of liver issues?

The use of PROGIRON is formally contraindicated (officially restricted from use) in individuals who have known or active severe liver disease or dysfunction. For patients with a less severe history of hepatic (liver) function concerns, regulatory information states that the use requires careful observation and monitoring.


Q: Is PROGIRON safe to use while breastfeeding?

Official labeling indicates that the use of PROGIRON is not recommended while breastfeeding. While some studies suggest that the medication may pose minimal risk to an infant, the product's official classification remains cautious for women who are breastfeeding.


Q: Are there any reported long-term effects of using PROGIRON for many years?

Regulatory warnings for this class of hormones are often informed by large, long-term studies exploring risks associated with menopausal hormone therapy (MHT) over several years of use. These studies examined potential risks such as blood clots and breast cancer. The relevance of these findings is noted in official documentation, and official documentation includes warnings regarding the potential risks for the hormone class.


Q: Does PROGIRON need to be refrigerated?

PROGIRON is officially required to be stored at a controlled room temperature, typically specified to be between 15 C and 30 C (59 F and 86 F). Official requirements explicitly state that the product must not be refrigerated or frozen, as this may compromise its stability.


Q: Is PROGIRON a type of antibiotic?

No. PROGIRON is classified as a Progestogen, a type of medication that acts as a Female Sex Hormone. Its active ingredient is Progesterone, and it is used for hormone replacement or physiological balancing, not for treating bacterial infections.


Q: How long does it usually take for PROGIRON to start having an effect?

Following oral administration, pharmacokinetic data show that the level of progesterone in the blood typically reaches its maximum concentration within approximately 2 to 4 hours. The full intended clinical effect on the uterine lining is a slower biological process that develops over the planned course of treatment.


Q: What happens if I stop using PROGIRON suddenly?

Official patient information contains a precaution against stopping the use of PROGIRON suddenly without consultation. For patients using the intramuscular regimen for conditions like secondary amenorrhea (lack of menstruation), a consequence of stopping treatment is expected withdrawal bleeding, which generally begins 48 to 72 hours after the final dose.


Q: Why is PROGIRON sometimes given as an injection instead of a tablet?

PROGIRON is offered in multiple forms to address the poor and rapid metabolism of the oral form. Regulatory documents indicate that the injectable route is used to achieve specific, higher concentrations of the hormone in the bloodstream. This may be required to support certain treatment goals, such as those required for luteal phase support.


Q: Is it common to feel tired when starting PROGIRON?

Fatigue and lassitude (tiredness) are listed in official safety documents as a common side effect, meaning they are reported to affect 1 to 10 users in every 100. Other related effects, such as dizziness and somnolence (drowsiness), are also documented in the product information.


Q: If PROGIRON is described as having 'limited research', what does that mean?

Phrases like 'limited research' or 'low certainty' in official drug reviews mean the available studies may not provide a high level of confidence in the outcome across all possible patient groups, or that more research is needed to determine the best approach. The findings are considered only applicable to the specific population that was studied in the clinical trials.


Q: What is the risk of an allergic reaction to PROGIRON?

Hypersensitivity (a severe allergic reaction) to any component is a formal contraindication for using the medication. Official labeling notes the presence of peanut oil in some formulations of the oral capsule, which is a major allergen and represents a formal contraindication for patients with a known peanut allergy.


Q: Does PROGIRON affect blood pressure?

While blood pressure changes are not listed as common side effects, postmarketing reports in official documentation have included instances of both high blood pressure (hypertension) and low blood pressure (hypotension). Additionally, the use of PROGIRON in patients with pre-existing high blood pressure requires careful observation.

How should PROGIRON be stored and disposed of?

How to Store and Dispose of PROGIRON: Official Requirements

Official regulatory information defines the specific conditions required to maintain the stability and effectiveness of PROGIRON. Storage must be conducted at a temperature below 30 C (or 25 C, depending on the specific regulatory document). It is explicitly stated or implied that the product must not be refrigerated or frozen.

The unopened product has a stated shelf-life of up to 4 years when stored correctly. PROGIRON is supplied in its original PVC/PVDC/Aluminium blister packaging, which provides necessary protection.

For disposal, any expired or unused PROGIRON must be discarded in strict accordance with local requirements for pharmaceutical waste. This ensures proper handling and environmental protection, requiring adherence to national or local collection programs rather than disposal in household trash.

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

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