Кломифен

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Кломифен

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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 Кломифен

Quick Facts

Property Description
Active ingredient Clomifene citrate
Form Oral tablets
Pharmacological class Selective Estrogen Receptor Modulator (SERM)
Common purpose Ovulation induction for anovulatory infertility
Origin Synthetic nonsteroidal derivative

What Type of Medicine is Кломифен?

Кломифен (Clomifene) is a synthetic nonsteroidal medication classified primarily as a Selective Estrogen Receptor Modulator (SERM). The active substance is Clomifene citrate, which is consistently administered as an oral tablet.

This compound is chemically derived from triphenyl ethylene stilbene, confirming its synthetic origin. The pharmacological classification as a SERM is clinically recognized for its ability to modulate the body's existing hormonal signals by binding to estrogen receptors in various tissues. Clomifene citrate is a single-ingredient product composed of two distinct isomers, Enclomiphene and Zuclomiphene, which contribute to its overall mixed estrogenic and antiestrogenic profile throughout the body. The original formulation established Clomifene as a first-generation pharmaceutical approach for this specific therapeutic goal.

What is the Purpose of Clomifene?

The general purpose of Clomifene is to serve as an ovulation stimulant, addressing hormonal imbalances that interfere with the regular release of an egg. Its use is focused on establishing the natural reproductive cycle in individuals experiencing anovulatory or oligo-ovulatory infertility.

Clomifene achieves this general therapeutic goal by indirectly influencing the hypothalamus, causing the body to perceive a state of low estrogen. This action encourages the pituitary gland to increase the release of natural gonadotropins, specifically Follicle-Stimulating Hormone (FSH) and Luteinizing Hormone (LH). This medication is integral to the initial treatment of infertility by promoting the development and maturation of ovarian follicles. Its role in supporting the gonadotropin surge makes it a recognized standard for patients seeking to restore ovulatory function.

Regulatory References

  1. Clomiphene: MedlinePlus Drug Information

What side effects are possible with Кломифен?

Possible Side Effects and Safety Information

The official safety profile of Clomifene Citrate is structured around adverse reactions classified by frequency and effect on specific body systems, as documented by regulatory agencies like the FDA and EMA.

Frequency-Classified Adverse Reactions

The most Common adverse reactions (ge 1/100 to <1/10) include vasomotor flushing (hot flashes), headache, nausea, vomiting, and dose-related ovarian enlargement or abdominal discomfort.

Uncommon reactions (ge 1/1,000 to <1/100) include visual symptoms such as blurred vision, spots, or flashes, as well as dizziness and insomnia. These visual symptoms are noted to be dose-related and typically lead to discontinuation of treatment.

Serious Adverse Reactions and Safety Constraints

Serious adverse reactions documented in regulatory sources include the risk of Ovarian Hyperstimulation Syndrome (OHSS), which can be severe but is rare. The possibility of significant visual loss, while typically reversible, has been reported and may require immediate cessation of use. The medication also carries a documented increased risk of multiple pregnancy and ectopic pregnancy.

Safety constraints and contraindications limit use in individuals with certain pre-existing conditions, including liver disease or a history of liver dysfunction, undiagnosed abnormal uterine bleeding, and specific types of ovarian cysts.

Official labeling indicates that the risk of ovarian cancer is associated with prolonged use (one year or more). This categorization by frequency and specific system involvement provides a standardized, objective overview of the medication’s risk profile.

Overdose and Emergency Response

Overdose and When to Seek Help

Regulatory documents define the Clomifene overdose profile based on documented physical signs observed following exposure to doses higher than recommended. Official labeling states that toxic effects accompanying acute overdosage have not been reported.

Documented Overdose Manifestations

System Affected Signs and Symptoms
Gastrointestinal Nausea, vomiting, abdominal and pelvic pain/discomfort.
Ocular/Visual Visual blurring, visual spots or flashes (scintillating scotomata).
Vascular Vasomotor flushes (hot flashes).
Reproductive Ovarian enlargement.

Emergency Action and Management

Official guidance mandates specific actions in cases of suspected overexposure:

  • Immediate Action Required: Seek emergency medical attention if overexposure is suspected. Urgent medical services must be called immediately if severe manifestations, such as collapse, seizure, trouble breathing, or unresponsiveness, are present.
  • Management: Treatment is defined as being symptomatic and supportive. Regulatory documentation specifies that no known antidote exists for overdosage. Supportive procedures, which may include gastric lavage, are used to manage the clinical presentation.
  • Note on Complications: Severe complications, such as Ovarian Hyperstimulation Syndrome (OHSS), are regulator-documented risks of higher exposure that may present with severe abdominal pain and distension.

Therapeutic Uses of Кломифен

What Кломифен Treats: Main Uses and Benefits

Кломифен is generally used to help address certain symptoms related to systemic imbalance affecting reproductive health. This medication is generally used in situations involving certain distressing symptoms. The application is relevant for managing symptom clusters that may become intense or disruptive, such as those related to irregular or absent egg release or low sperm production.

The therapeutic application is relevant for managing symptom clusters that may become intense or disruptive, such as those related to irregular or absent egg release (anovulation) in women and, in some cases, certain issues related to low sperm production in men. It is commonly used when reproductive function is affected and may assist with general functional support.

“ Кломифен helps maintain a sense of stability when symptoms are more noticeable, supporting the patient during difficult episodes by easing distress related to functional strain.”

The overall benefit is that it helps improve day-to-day comfort during symptomatic periods by addressing organ-specific functional stress.

Quick Fact: Support for Reproductive Functional Strain Кломифен is applied in clinical settings that involve recurrent or episodic manifestations of hormonal imbalance impacting fertility, supporting patients during episodes of heightened discomfort.

Regulatory References

  1. NIH MedlinePlus Drug Information

Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Кломифен — Official Regulatory Information

The eligibility profile for Clomifene is strictly defined by regulatory authorities and is generally limited to adult women with demonstrated ovulatory dysfunction who are seeking pregnancy. Use is not established in the pediatric population.


Contraindicated Populations (Must Not Use)

Clomifene is contraindicated in several specific populations and conditions, as mandated by official labeling (FDA, EMA). Individuals must not use the medicine if they are pregnant or have:

  • Active liver disease or a history of liver dysfunction.
  • Abnormal uterine bleeding of undetermined origin.
  • Ovarian cysts or enlargement not caused by polycystic ovary syndrome (PCOS).
  • An organic intracranial lesion (e.g., pituitary tumor).
  • Uncontrolled thyroid or adrenal dysfunction.

Restrictions and Conditional Use

Use is ineffective and therefore not recommended for patients with primary pituitary or ovarian failure. Caution is required for patients with uterine fibroids due to the potential for enlargement. For lactation/breastfeeding, caution is advised as Clomifene may potentially reduce milk supply.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile of Кломифен (Clomifene citrate) is defined primarily by potential pharmacodynamic overlap with other hormonal agents, as documented by official regulatory sources.

Documented Interaction Patterns

Interaction Type Interacting Agent or Condition Constraint Stated in Regulatory Labels
Therapeutic Duplication Ospemifene (another SERM) Combination is generally restricted or contraindicated due to pharmacodynamic synergism and heightened risk of combined effects.
Additive Risk Gonadotropins (other ovulation agents) Co-administration introduces a documented additive risk for Ovarian Hyperstimulation Syndrome (OHSS).
Population-Specific Risk Preexisting/Family History of Hyperlipidemia This condition is a documented risk factor associated with an elevated risk of hypertriglyceridemia during treatment.

Summary of Regulatory Constraints

The official labeling restricts combining Кломифен with other Selective Estrogen Receptor Modulators (SERMs) due to potential additive effects on estrogen receptors. When used alongside Gonadotropins, the overall ovarian stimulation effect is increased, necessitating caution due to the severe, documented risk of OHSS. Furthermore, patients with a history of high lipid levels are identified as a population requiring specific monitoring due to the risk of developing hypertriglyceridemia. No specific timing requirements or pharmacokinetic interactions involving CYP enzymes or transporters are explicitly stated in the regulatory summaries.

Mechanism of Action

How Clomiphene Works: Mechanism of Action

Clomiphene citrate functions as a Selective Estrogen Receptor Modulator (SERM). The primary mechanism involves the competitive antagonism of Estrogen Receptors (ERs), predominantly in the hypothalamus and pituitary gland, by the Enclomiphene isomer. This central blockade prevents endogenous estrogen ( 17beta-Estradiol) from binding to its physiological target sites, functionally overriding the normal estrogen-mediated negative feedback loop.

This disinhibition leads the central system to perceive a state of functional hypoestrogenism, which triggers a compensatory cascade. The hypothalamus responds by increasing the pulsatile secretion of Gonadotropin-Releasing Hormone (GnRH). This surge then stimulates the anterior pituitary to heighten the output of Follicle-Stimulating Hormone (FSH) and Luteinizing Hormone (LH) into the systemic circulation.

The resulting elevated levels of FSH and LH stimulate the ovaries to initiate the growth and maturation of follicles, which is the main physiological consequence of this mechanism. Clomiphene also involves binding to ERs in peripheral tissues, leading to modulation of endometrial thickness and alteration of cervical mucus quality, which represents a mechanistic trade-off.

Dosage and Administration Information

Clomiphene citrate is an oral, nonsteroidal fertility medication used to stimulate ovulation in women who are not ovulating regularly on their own, often due to conditions like Polycystic Ovary Syndrome (PCOS). This medication should only be used under the direct supervision of a healthcare professional after a thorough medical evaluation, including a pelvic examination, to rule out pregnancy, ovarian cysts, or other contraindications prior to each treatment course.

Dosage and Administration

Clomiphene is typically available as a 50 mg tablet. The standard initial dosage for ovulation induction is 50 mg once daily for 5 days.

Course of Treatment Dosage Duration Starting Day of Cycle
First 50 mg daily 5 days On or about Day 5 of the menstrual cycle*
Subsequent May be increased to 100 mg daily 5 days On or about Day 5 of the menstrual cycle*

*If you experience spontaneous bleeding, the first day of full menstrual flow is counted as Day 1. If menstruation is absent, your doctor may induce a period with progestin therapy, and treatment can begin on any day.

If ovulation does not occur after the initial course, the treatment may be repeated as early as 30 days after the prior therapy, but only after excluding the presence of pregnancy. The dosage may be increased to 100 mg daily for 5 days in subsequent cycles for non-responders, up to a maximum dose of 250 mg daily, using the lowest effective dose.

Duration of Use: Long-term cyclic therapy is not recommended beyond a total of about six cycles, including three ovulatory cycles, due to a small, potential long-term risk of ovarian cancer. Ovulation is most likely to occur 5 to 10 days after the last dose.

Recent Clinical Evidence

Overview of Studies for Кломифен

Research into Кломифен has primarily focused on its use in certain conditions characterized by fluctuating or episodic manifestations related to the menstrual cycle. Most of the evidence comes from clinical trials, where the medication was studied for its ability to influence specific outcomes related to systemic or functional imbalance in women who were not ovulating regularly. Research often examined the medication in controlled settings to explore changes compared to a placebo or no treatment. These trials often involved observing short-term symptom changes over defined time intervals.


Evidence for use in Ovulation Induction in Polycystic Ovary Syndrome (PCOS)

A significant portion of the research for Кломифен was studied for its use in women diagnosed with Polycystic Ovary Syndrome (PCOS). This condition is often marked by functional limitations related to irregular or absent ovulation. Studies examined whether the medication was associated with changes in ovarian function, such as the release of an egg. Findings generally show patterns related to an increase in the number of women who ovulated during the study period. However, not all women in the study populations experienced the measured outcomes; in fact, observed changes were observed in some studies to vary significantly.


Long-term Studies and Follow-up

Research focusing on the extended impact of Кломифен is generally much more limited. The follow-up durations were limited in the vast majority of studies, which focused predominantly on the immediate observation of ovulation. This means that long-term effects are not fully established because the medication was studied for short, defined cycles. There is limited information for long-term outcomes or the durability of the response after treatment is stopped.


What is Still Uncertain about Кломифен

Research provides insight into short-term changes, but there are clear evidence gaps. One area of uncertainty is why some individuals in the studies did not experience the measured outcome (did not ovulate). Additionally, while trials report how symptoms evolved in the observed populations, comparative evidence is lacking to definitively show how Кломифен compares to every other newer medication or treatment approach. These findings describe group patterns, not personal outcomes, and highlight where more focused, higher-quality research is needed.

Key Studies & References

  1. Evidence-based treatments for couples with unexplained infertility: A Guideline - ASRM Practice Committee Document (2020)

Frequently Asked Questions (FAQ)

Common questions about Кломифен (FAQ)

Q: How quickly should someone expect Кломифен to start working?

Clomiphene is intended to stimulate the ovulation process. Official information indicates that the resulting ovulation is generally expected to occur between 5 and 10 days after a person takes the final dose of the medication in a given treatment cycle.

Q: Does Кломифен always cause weight gain?

Weight gain is not listed as a common side effect of the medication itself. However, official safety documentation notes that weight gain is a possible symptom that may be associated with ovarian enlargement or, in rare cases, Ovarian Hyperstimulation Syndrome (OHSS).

Q: Can Кломифен affect vision or cause blurry sight?

Yes, visual symptoms such as blurred vision, spots, or flashes are listed in the official safety profile as a possible adverse reaction. Regulatory information indicates that the medication may be immediately discontinued if these symptoms occur. While these changes are often reversible, official reports also state that cases of prolonged and potentially irreversible visual changes have been reported.

Q: Can older women still use Кломифен?

Official labeling restricts the use of Clomiphene to adult women with ovulatory dysfunction. The medication is not recommended for patients who have primary ovarian failure, as its use is generally considered ineffective in this condition, which can be associated with age.

Q: Can I take vitamins or supplements along with Кломифен?

Official regulatory documents detail specific drug-drug interactions, such as those with other Selective Estrogen Receptor Modulators or Gonadotropins. However, these documents do not explicitly address interactions with general supplements or vitamins.

Q: Does Кломифен cause hot flashes in everyone who takes it?

No, it does not happen to everyone. Vasomotor flushing (commonly known as hot flashes) is listed in the official safety profile as one of the most Common adverse reactions, meaning it occurs in a significant number of people who take the medicine.

Q: Can someone stop taking Кломифен suddenly?

Regulatory information specifically states that the medication should be immediately discontinued if a person experiences visual symptoms. For cessation in other circumstances, a healthcare provider should be consulted.

Q: Does taking Кломифен make ovulation painful?

Abdominal discomfort or pelvic pain is listed as a common adverse reaction in the official product information. This discomfort is often related to ovarian changes, which may include ovarian enlargement or, potentially, the process of ovulation.

Q: Can Кломифен affect my mood or mental health?

Official safety data lists Insomnia as an Uncommon adverse reaction. Other reported effects in official documentation include mood swings and irritability.

Q: Does taking Кломифен increase the risk of twins?

Yes, the official safety information carries a documented increased risk of multiple pregnancy. This risk includes both twins and higher-order multiples.

Q: Can Кломифен be used for issues other than infertility?

The general purpose of the medication is officially documented as serving as an ovulation stimulant. Its indicated use is restricted to individuals experiencing anovulatory or oligo-ovulatory infertility.

Q: How long do most people typically need to take Кломифен?

Official guidance states that long-term cyclic therapy is not recommended beyond a total of about six cycles. This duration limit is due to a potential small long-term risk of ovarian cancer.

Q: Does Кломифен affect the results of other medical tests?

Yes, there is a possibility of interference. Official documentation indicates that the medication may cause false positive results when using home ovulation predictor kits that detect the Luteinizing Hormone (LH) surge.

Q: Is there a generic version of Кломифен?

Yes, the medication's active ingredient is Clomifene citrate, which is widely available as a generic formulation.

Q: How does the action of Кломифен differ from injectable fertility treatments?

Кломифен is a Selective Estrogen Receptor Modulator (SERM) and is taken orally. Other ovulation agents, such as gonadotropins, are hormonal agents that are often given as injections. Regulatory documents note that using the two types of agents together carries a documented additive risk for Ovarian Hyperstimulation Syndrome (OHSS).

Q: Why is it important to have a specific diagnosis before starting Кломифен?

Official guidance states that use should only occur under medical supervision after a thorough evaluation. This is necessary to rule out pregnancy, ovarian cysts, or other contraindications prior to each course of treatment.

Q: Is Кломифен used in IVF treatment?

The official labeling does not define a standard regimen for the medication's use in in vitro fertilization (IVF) programs. Its primary use is for ovulation induction in women who are not ovulating regularly.

Q: Are there any specific foods that interact with Кломифен?

Regulatory summaries focus on detailing specific drug-drug interactions and conditions (such as hyperlipidemia) that may present a risk. They do not explicitly detail interactions with specific common foods.

Q: What kind of monitoring is typically done when someone is on Кломифен?

Official prescribing information details required evaluations, including a pelvic examination before each course of treatment. Monitoring for certain conditions, such as hypertriglyceridemia in at-risk patients, is also required.

Q: Does using Кломифен increase the chance of miscarriage?

Official human data on the medication does not suggest an increased rate of spontaneous abortion (miscarriage) among subfertile women who were treated with the drug.

Q: Is it true that Кломифен can be used to treat low testosterone in men?

The official labeling for Кломифен is restricted to adult women with ovulatory dysfunction. The official documentation indicates that the drug's effectiveness for treating male infertility is not established through adequate or well-controlled studies.

Q: Is it okay to drive or operate machinery while taking Кломифен?

Because visual disturbances may occur occasionally during or shortly after treatment, caution should be exercised regarding activities such as driving a car or operating machinery.

Q: Can I use alcohol while I am using Кломифен?

Regulatory summaries note that there is a documented interaction between the medication and alcohol. This is an important consideration when using the drug.

How should Кломифен be stored and disposed of?

How to Store and Dispose of Clomiphene Citrate

Clomiphene citrate tablets must be stored according to specific regulatory requirements to maintain product stability and safety.

Storage Requirements

Condition Requirement
Temperature Store at Controlled Room Temperature, 20 C to 25 C (68 F to 77 F).
Protection Protect from light, excessive moisture, and extreme heat.
Handling Keep in a tightly closed container and do not freeze.
Child Safety Must be stored out of the reach and sight of children.

Disposal Instructions

Unused or expired tablets should be disposed of by following official protocols. The preferred method is utilizing a medicine take-back program or authorized collection point. If a take-back program is unavailable, the product may be discarded in household trash after being mixed with an undesirable substance, such as dirt or used coffee grounds, and sealed in a bag. Do not dispose of the tablets by flushing them down the toilet.

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

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