Femstat

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Femstat

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 Femstat

Quick Facts

Property Description
Active Ingredient Butoconazole Nitrate
Form Vaginal Cream (Cream base)
Pharmacological Class Azole Antifungal, Imidazole derivative
Common Use Localized fungal infections (e.g., Vulvovaginal Candidiasis)
Origin Synthetic

What Type of Medicine is Femstat (Butoconazole)?

Femstat is the trade name for a medication whose core ingredient is the chemical compound Butoconazole Nitrate, specifically classified as an Azole Antifungal agent. This substance is a synthetic imidazole derivative that targets and disrupts fungal organisms. The drug's classification places it under the World Health Organization (WHO) grouping of Imidazole derivatives. This entity is a single active ingredient product, focusing its therapeutic profile on its function as a concentrated vaginal anti-infective designed for localized treatment.

Composition and Local Delivery Form

The medicinal agent, Butoconazole Nitrate, is incorporated into an emollient cream base to create a Vaginal Cream, which is the designated dosage form. The formulation is intended for an intravaginal (local) route of administration, a feature that differentiates it from orally administered antifungals. By utilizing this local delivery method, the product allows the active ingredient to be applied directly to the site of infection to facilitate local action while limiting the amount of the drug that undergoes systemic absorption.

General Purpose and Mechanism Summary

The primary general purpose of this medication is to neutralize the localized fungal organisms associated with common infections, such as Vulvovaginal Candidiasis (VVC). Butoconazole functions by interfering with the structural components of the fungal cell membrane. Imidazole derivatives block the production of ergosterol, a sterol essential for the pathogen's survival, thereby altering the cell's integrity. This specific mechanism of inhibiting ergosterol synthesis targets the cause of the infection and the associated discomfort.

Regulatory References

  1. NIH DailyMed: Butoconazole Cream Label

What side effects are possible with Femstat?

Possible Side Effects and Safety Information

Butoconazole Nitrate vaginal cream is an azole antifungal agent intended for localized administration. The safety profile, derived from regulatory documents and clinical trials, reflects that adverse reactions are primarily local and are classified as common (occurring in 1% or more of patients). Serious adverse reactions are possible, requiring awareness of specific safety constraints.


Common Adverse Reactions (Incidence 1%)

Adverse effects reported in clinical trials primarily affect the Genitourinary System and the Gastrointestinal System. These commonly include localized symptoms:

System Affected Common Complaints
Genitourinary System Vulvar/Vaginal burning, itching, soreness, and swelling
Gastrointestinal System Pelvic pain, abdominal pain, or cramping

Safety Considerations and Restrictions

Serious Reactions: Known hypersensitivity or allergy to Butoconazole Nitrate or any component of the cream is cited in official labeling as a contraindication for use.

Population-Specific Notes: The medication is classified as Pregnancy Category C by the FDA, and its use should only proceed if the potential benefit justifies the potential risk. It is unknown if the drug is excreted into human milk. Safety and effectiveness have not been established in children.

Latex/Rubber Product Interaction: The cream contains mineral oil, an excipient that may weaken latex or rubber products such as condoms and vaginal contraceptive diaphragms. Official safety information advises that the use of such barrier products is not recommended within 72 hours (three days) following treatment. Recurrent infections may also signal a more serious underlying medical condition.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory guidance for Femstat (Butoconazole Nitrate) overdose focuses on the risk of accidental oral ingestion of the vaginal cream. Due to the product's formulation for local use and its low rate of systemic absorption, an overdose resulting from excessive topical application is unlikely to occur. However, the product is formally documented as potentially harmful if swallowed, establishing accidental ingestion as the primary concern outlined in official prescribing information.

In the event of accidental oral exposure, the immediate action required is to contact a Poison Control Center right away for guidance. Urgent medical attention is mandated by calling emergency services if the individual develops serious symptoms, specifically including passing out or experiencing trouble breathing. These outcomes represent the severe scenarios that require immediate intervention as defined by the label.

Management for Butoconazole overdose is strictly defined as symptomatic and supportive therapy. Regulatory documentation confirms that no specific treatment or antidote is known for this overdose scenario. Beyond the stated triggers for seeking urgent help, no specific clinical manifestations are detailed in the official prescribing information, and no population-specific risks are noted in this section.

Therapeutic Uses of Femstat

What Femstat Treats: Main Uses and Benefits

Femstat (Butoconazole Nitrate) is applied in addressing the localized management of Vulvovaginal Candidiasis (VVC), which is commonly known as a vaginal yeast infection. Its therapeutic role is centered on managing the acute, distressing symptoms that define this condition and is applied across domains where additional symptomatic support is needed.


Quick Fact: Symptomatic Support for Acute Discomfort

Symptom Domain Description
Primary Use Localized management of Vulvovaginal Candidiasis (VVC).
Symptom Focus Vaginal itching (pruritus), burning sensation, and external vulvar irritation.
Benefit Aim Offers symptomatic relief that supports the patient during difficult episodes.

The medication is considered relevant in clinical settings marked by acute symptomatic episodes and is used when groups of symptoms appear suddenly or fluctuate. Femstat's usage is relevant across domains where additional symptomatic support is needed for conditions presenting with localized discomfort and irritative states. By helping ease these challenging symptoms, Femstat may assist with providing supportive relief when symptoms interfere with daily functioning, contributing to improved day-to-day comfort during symptomatic periods.

Regulatory References

  1. NIH MedlinePlus overview of Butoconazole Vaginal Cream

Eligibility and Restrictions for Use

Who Can and Cannot Use Femstat (Butoconazole Nitrate)

This eligibility information is based strictly on authoritative governmental regulatory documents.


Contraindications (Must Not Use)

Classification Population/Condition
Absolute Prohibition Individuals with a known hypersensitivity or allergy to butoconazole nitrate or any of the product’s components.

Restricted or Conditional Use

  • Pregnancy: Use is generally conditional and advised only if the potential benefit justifies the potential risk to the fetus, as there are no adequate and well-controlled human studies (classified as Category C under the old US system).
  • Nursing Mothers: Caution should be exercised when using this medication, as it is not known whether the drug is excreted into human milk.
  • Contraceptive Use: The cream contains mineral oil, which may weaken latex or rubber products such as condoms or vaginal contraceptive diaphragms. Use of these barrier contraceptives is not recommended for 72 hours following treatment.

Age-Based Exclusion

  • Pediatric Patients: Safety and effectiveness have not been established in children.

What should I know about interactions with other medicines?

Interaction Map: Interactions with other medicines and products — official regulatory information for Femstat

Interaction Scope

Category Official Regulatory Statement for Femstat (Butoconazole Nitrate)
Medicinal product categories with documented interactions None. Official documents cite no known interactions with other medicinal products.
Specific interacting medicines (if explicitly listed) None. No specific co-administered drugs are listed as interacting.
Mechanistic basis of interactions (only if stated in label) Drug-Substance Interaction: An inactive ingredient, mineral oil, is cited as potentially weakening the material of certain contraceptive products.
Timing-based interaction rules (if applicable) 72 hours (three days) following treatment is the mandated period during which use of specific latex/rubber products must be avoided.
Population-specific interaction notes (if applicable) None documented. Official labeling contains no specific interaction cautions related to populations such as the elderly, hepatic impairment, or pediatric use.
Interaction-related restrictions Avoidance of latex or rubber barrier contraceptives (e.g., condoms, vaginal diaphragms) during and for 72 hours after treatment.

Interaction Classifications (High-Level)

Classification Official Regulatory Statement for Femstat (Butoconazole Nitrate)
Interaction severity classification (as defined in official documents) Product Compromise Risk requiring a mandatory timing restriction.
Regulatory basis (EMA / FDA / etc.) U.S. Food and Drug Administration (FDA) / DailyMed prescribing information.
Interaction-context constraints (as defined in official documents) Non-DDI (Drug-Drug Interaction): The restriction relates to a substance-product incompatibility, not a drug metabolism or pharmacodynamic effect on a co-administered medicine.

Resulting Interaction Structure

Official Interaction Statements:

  • Regulatory documents state that no known interactions exist between Butoconazole Nitrate and other co-administered medicinal products, foods, or alcohol.
  • The only documented interaction-related restriction involves the potential for an inactive ingredient, mineral oil, to compromise the integrity of latex or rubber barrier contraceptives.
  • Due to this potential compromise, the regulatory labeling mandates that the use of such contraceptive products must be avoided for 72 hours following the completion of treatment with the cream.

Connection to the Overall Interaction Profile (2–4 sentences):

The official regulatory documents define the product's interaction structure as being characterized by a lack of known drug-drug interactions (DDI) across pharmacokinetic and pharmacodynamic classes. The profile's only mandatory constraint is a timing-based restriction of 72 hours related to a single drug-substance/product interaction, where an excipient in the cream may weaken the material integrity of latex or rubber barrier contraceptives.

Mechanism of Action

How Femstat Works: Antifungal Pharmacodynamics

Femstat (butoconazole) is an imidazole antifungal that operates by disrupting essential biosynthetic processes and structural elements within fungal cells. The mechanism focuses on the inhibition of specific intracellular enzymes and the subsequent alteration of the fungal cell membrane integrity.

Butoconazole functions as an inhibitor of the fungal enzyme lanosterol 14-alpha-demethylase, a member of the cytochrome P450 enzyme family. Inhibition of this enzyme suppresses an initial step in the biosynthetic pathway that produces ergosterol, which is the primary sterol component of the fungal cell membrane.

The resulting mechanistic cascade leads to a critical deficiency of ergosterol and a simultaneous accumulation of toxic, methylated sterol precursors within the cell. This dual effect alters the fungal cell membrane's lipid composition, which increases its fluidity and permeability, leading to compromised structural integrity and osmotic imbalance.

Dosage and Administration Information

How Femstat is Used

Femstat (Butoconazole Nitrate) is administered strictly via the intravaginal route as a 2% cream, which is the sole approved dosage form. The use of a special applicator supplied with the product is required for proper administration.


Dosing and Frequency

The standard adult regimen for uncomplicated use is a single dose of one full applicatorful of the 2% cream, which is equivalent to approximately 100 mg of Butoconazole Nitrate. This administration is typically performed as a single-day course.

Administration is generally advised to occur at bedtime to optimize retention and effectiveness of the medication.


Course Duration and Population Specifics

While the primary treatment is a one-day course, an extended duration is documented for specific scenarios. For instance, in pregnant patients during the second or third trimester, an alternative regimen of one applicatorful administered once daily for seven consecutive days is often used. The safety and effectiveness of the cream have not been established for pediatric patients under 18 years of age.


Administration Constraints

The product labeling includes a constraint regarding the use of certain products with the medication. Due to the presence of mineral oil in the cream, which may damage the material, the use of latex or rubber products (such as condoms or diaphragms) must be avoided for 72 hours (three days) following treatment. Furthermore, the use of tampons is advised against during the course of treatment to prevent drug absorption.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Femstat

This section summarizes the structure of the research evidence for the clinical evaluation of Femstat (Butoconazole Nitrate), focusing strictly on the types of studies conducted, the populations included, and what findings were reported in authoritative sources. This information is intended to provide context on the scientific background of the medication.


Evidence for Acute Symptomatic Vulvovaginal Candidiasis (VVC)

The core evidence used to evaluate Femstat primarily comes from Randomized Controlled Trials (RCTs). These are considered the most common design for studying a medicine’s clinical evaluation. In these trials, researchers examined the use of the cream in healthy adult women presenting with acute symptoms of a yeast infection.

Studies were conducted during periods of increased symptom activity and research examined two main types of outcomes. The first was Clinical Outcome Assessment, which involved monitoring patient-reported outcomes describing perceived discomfort. The second was Mycologic Outcome Assessment, which meant achieving a negative result on laboratory tests for the presence of the Candida fungus. The combination of these two measurements formed the primary endpoint for the study’s evaluation. Findings describe patterns observed in the studies related to measurements of both clinical and mycologic outcomes within a short follow-up period.


Long-Term Evidence and Durability of Effect

For Femstat, the initial efficacy assessments typically extended to only 30 days post-treatment. This focus means the follow-up durations were limited, and the evidence regarding long-term symptom patterns is not fully established by the core registration trials. Because long-term effects are not fully established, researchers have also explored the context of recurrent Vulvovaginal Candidiasis (RVVC). Research for this situation often relies on smaller observational studies or data synthesized from guidelines for azoles as a class, which observed patterns related to symptomatic recurrence over a longer period, sometimes up to six months.


Research Gaps and What Remains Uncertain

The overall evidence base provides context on short-term outcomes in VVC, but several areas remain uncertain or require further research. Data for certain groups remain limited. For example, the clinical evaluation in pregnant women has not been conducted in adequate and well-controlled studies. Consequently, official regulatory documentation outlines specific evidence gaps regarding its use during pregnancy because the evidence base is insufficient. Additionally, data are still emerging regarding its use in complex cases or in populations with underlying health conditions, and research does not determine whether an individual will respond similarly to the group findings.

Key Studies & References

  1. Butoconazole Nitrate Cream, USP (Butoconazole Cream) Official FDA Label/DailyMed Monograph
  2. WHO Anatomical Therapeutic Chemical (ATC) Classification System - G01AF15 Butoconazole
  3. Butoconazole: MedlinePlus Drug Information

Frequently Asked Questions (FAQ)

Common questions about Femstat (FAQ)

Q: How quickly do people typically expect to notice the effects of Femstat?

A: Clinical studies have examined the timing of symptom improvement. Trial data has indicated that for many participants, improvement in discomfort was reported within the first few days following the single application. The official product information emphasizes that outcomes can vary among individuals.

Q: Does taking Femstat with food change how it works?

A: Regulatory documents state that there are no known interactions between Butoconazole Nitrate and foods. The official instructions for use do not place any restrictions on food consumption during the course of treatment.

Q: Can Femstat interact with common pain relievers like ibuprofen or aspirin?

A: According to the official product information, there are no known interactions between Femstat (Butoconazole Nitrate) and other medicinal products. This statement of no known interactions includes common non-prescription pain relievers like ibuprofen or aspirin.

Q: Is it necessary to avoid alcohol completely while using Femstat?

A: Regulatory documents state there are no known interactions between Butoconazole Nitrate and alcohol. The official instructions do not contain a mandate for the complete avoidance of alcohol.

Q: How long is Femstat typically prescribed for?

A: The primary treatment is typically a one-day course. An alternative duration is documented for specific scenarios, such as pregnant patients in their second or third trimester, where daily use for seven consecutive days may be used.

Q: Does Femstat affect hormonal balance?

A: Femstat is classified as an imidazole antifungal, and its mechanism is specific to disrupting fungal cells by inhibiting the production of a substance called ergosterol. This process is focused on the fungus and does not involve human hormonal pathways.

Q: Is it true that Femstat can cause sensitivity to sunlight?

A: The reported adverse reactions for Femstat primarily involve localized vulvovaginal symptoms such as burning, itching, and swelling. Sensitivity to sunlight (photosensitivity) is not listed among the common or less common reported side effects in the official labeling.

Q: Is Femstat available over the counter, or does it require a prescription?

A: Butoconazole Nitrate vaginal cream is a prescription medicine. It is not available for purchase over the counter and is dispensed only upon prescription.

Q: Are there different strengths or types of Femstat available?

A: The sole approved form of Femstat (Butoconazole Nitrate) is a 2% cream. This is the only strength and type of this medication that is strictly intended for intravaginal administration.

Q: Can Femstat be used for symptoms other than its main approved use?

A: Butoconazole Nitrate Vaginal Cream 2% is officially indicated solely for the local treatment of fungal infections caused by Candida (vulvovaginal candidiasis). The official indication does not include any other uses.

Q: Is it common to feel worse before feeling better when starting Femstat?

A: Common side effects reported after administration include local symptoms like vulvar/vaginal burning, itching, or swelling. These common complaints may be experienced shortly after application.

Q: Can Femstat cause changes to a person's mood or behavior?

A: Changes to a person's mood or behavior are not listed among the common or less common adverse reactions in the official product labeling. The medication is designed for local action, which limits systemic exposure.

Q: Do studies show that Femstat's effectiveness changes over time with continuous use?

A: The core registration trials have limited follow-up duration, and the evidence regarding long-term symptom patterns is not fully established. Researchers have also explored the context of recurrent infections which often relies on data synthesized from guidelines for its drug class.

Q: Can I crush or split the Femstat tablet/capsule?

A: Femstat is only available as a cream that is applied using a special applicator; it is not available in tablet or capsule form. As a cream, it must be used as directed for intravaginal application and is not intended to be crushed or split.

Q: Are there specific food types or drinks that should be avoided while on Femstat?

A: Regulatory documents state that no known interactions exist between Butoconazole Nitrate and foods or drinks. Based on this, there are no specific foods or beverages that need to be avoided during treatment.

Q: How does the mechanism of action for Femstat compare to older treatments?

A: Femstat's active ingredient, butoconazole, is an imidazole antifungal. This type of drug works by targeting and inhibiting a specific fungal enzyme, which disrupts the cell membrane. This mechanism is common for its drug class.

Q: What do official documents say about Femstat use with kidney problems?

A: Official regulatory documents do not provide specific warnings or dosage adjustments for patients with kidney impairment. This may reflect the drug's limited systemic absorption following local application.

Q: What do official documents say about Femstat use with liver problems?

A: Official regulatory documents do not provide specific warnings or dosage adjustments for patients with liver impairment. This may reflect the drug's limited systemic absorption following local application.

Q: Is Femstat known to affect driving or operating machinery?

A: The reported adverse reactions primarily involve localized vulvovaginal symptoms and minor pain or cramping. No side effects related to functional impairment, such as drowsiness or dizziness, are commonly reported in the official labeling.

Q: Is Femstat considered a controlled substance?

A: Butoconazole Nitrate is classified by regulatory agencies as an antifungal agent. It is not listed or scheduled as a controlled substance under the U.S. Controlled Substances Act.

Q: Are weight changes a common or rare side effect of Femstat?

A: Weight changes are not listed among the common or less common adverse reactions in the official product labeling. The medication is designed for local action, which typically limits the amount of drug absorbed systemically.

Q: Can Femstat be taken at any time of day?

A: Official information advises that administration is generally performed at bedtime. This recommendation is given to optimize the medication's retention and effectiveness at the site of infection.

Q: Does Femstat show up on drug tests?

A: The medication is applied locally, and studies show that only a small amount of the dose is absorbed into the bloodstream. The official labeling does not contain information on whether this level of systemic absorption would cause a positive result on standard drug tests.

Q: What are the ingredients listed in the Femstat formulation besides the active drug?

A: The official product labeling lists the active drug, Butoconazole Nitrate, and various inactive ingredients that make up the cream base. One such ingredient is mineral oil, which is cited for its potential to weaken certain latex or rubber products.

Q: Does Femstat contain gluten or lactose?

A: The inactive ingredients list in the official labeling for the vaginal cream does not include lactose or gluten as components. The full list of excipients should be consulted for specific allergy concerns.

Q: Is there a generic version of Femstat available?

A: Yes, there are generic versions of Butoconazole Nitrate 2% vaginal cream that have been approved by the FDA. These generics are considered therapeutically equivalent to the brand-name product.

Q: What are the key differences between the original brand and a generic version of Femstat?

A: A generic version approved by the FDA is considered therapeutically equivalent to the brand name, meaning it contains the same active ingredient, is the same dosage form, and meets the same standards for quality and strength. Differences are typically limited to inactive ingredients, packaging, and cost.

Q: Do clinical studies on Femstat include diverse patient populations?

A: The core evidence for the single-dose regimen was primarily derived from studies in healthy adult women diagnosed with acute infection. Official documentation notes that data for certain groups, such as pregnant women and pediatric patients, remain limited.

Q: Is the information on how Femstat works considered fully understood by researchers?

A: Official regulatory documents state that the exact mechanism of the antifungal action of butoconazole nitrate is not entirely known. However, based on its chemical class, it is presumed to work by inhibiting ergosterol synthesis in the fungal cell.

How should Femstat be stored and disposed of?

How to Store and Dispose of Femstat?

Femstat (butoconazole nitrate) Vaginal Cream must be stored at controlled room temperature, specifically between 20 C to 25 C (68 F to 77 F). The medication must not be frozen and should be kept away from excess heat and moisture; for instance, the bathroom is a prohibited storage location.

Storage and Protection

Requirement Status
Temperature Controlled Room Temp.
Freezing Must Not Freeze
Container Original and Tightly Closed
Child Safety Keep Out of Reach of Children

Store the cream in its original container, ensuring it remains tightly closed and secured out of the sight and reach of children.

Disposal

Official disposal guidelines recommend using a drug take-back program for unused or expired product. If a take-back option is unavailable, the cream should be mixed with an undesirable substance (such as kitty litter), sealed in a bag, and then discarded in the household trash. Identifying information must be removed from the container label before disposal.

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

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