Finatra

Quick links to important sections

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 Finatra

Finatra Quick Facts

Property Description
Active ingredient Finasteride (C23H36N2O2)
Form Oral, film-coated tablet
Pharmacological class 5α-Reductase Inhibitor (5-ARI)
General purpose Management of DHT-driven hormonal conditions
Origin Synthetic azasteroid compound

What is Finatra, and What Class of Medicine Does it Belong To?

Finatra is a prescription medication whose active component is the synthetic agent Finasteride, which is formally classified as a specific 5α-Reductase Inhibitor (5-ARI). This pharmacological classification identifies it as an enzyme inhibitor, a type of medicine that modulates a specific biological process by blocking the action of an enzyme. Finasteride is an azasteroid compound, highlighting its chemically engineered nature. The core principle of this medicine is its high selectivity for the Type II 5α-reductase enzyme, a factor clinically recognized for its targeted suppression of androgen activity in specific tissues.

Finatra's Composition and Physical Form

Finatra is administered as an oral, film-coated tablet, a preparation designed for efficient systemic absorption rather than localized application. Its identity is that of a single-ingredient product, containing only Finasteride along with necessary solid pharmaceutical excipients to facilitate its controlled oral delivery. The presentation as a film-coated tablet is a distinctive feature of the formulation, ensuring stability and a measurable route of administration for systemic therapy.

General Therapeutic Role and Purpose

The general therapeutic purpose of Finatra is the foundational management of conditions rooted in the activity of the potent androgen hormone Dihydrotestosterone (DHT). Finatra achieves this by specifically targeting and inhibiting the enzyme that produces DHT from testosterone. Finasteride is classified as a drug primarily used to reduce elevated DHT levels. This reduction provides a sustained mechanism for restoring hormonal balance in male patients, offering long-term physiological support for conditions where DHT imbalance is medically relevant.

What side effects are possible with Finatra?

Possible Side Effects and Safety Information

The officially documented safety profile of Finatra (Finasteride) is structured by classifying possible effects based on their frequency and the body system affected, strictly following regulatory standards.

Frequency-Classified Adverse Reactions

Adverse reactions documented in official prescribing information are typically grouped by incidence:

  • Common (may affect up to 1 in 10 men): Decreased libido (sexual drive), erectile dysfunction (impotence), and ejaculation disorders (including decreased volume).
  • Uncommon (may affect up to 1 in 100 men): Skin rash, breast tenderness, and/or breast enlargement (gynecomastia).
  • Frequency Not Known (based on post-marketing surveillance): This category includes reports of depression, anxiety, insomnia, testicular pain, and hepatic enzyme elevations.

Serious Adverse Reactions and Safety Constraints

Regulatory documents include reports of more serious, rare events. These include post-marketing reports of severe depression (including suicidal ideation) and cases of male breast cancer; a definitive causal relationship is not established but these are noted in official labeling. Severe hypersensitivity reactions, such as angioedema (swelling of the face or lips), are also documented.

Finatra is contraindicated for use in women who are or may become pregnant due to the risk of causing external genital abnormalities in a male fetus. A key safety constraint for male patients is the drug's effect on Prostate-Specific Antigen (PSA) levels, which are reduced by approximately 50%; this reduction must be accounted for when interpreting prostate cancer screening results. Furthermore, certain sexual and psychiatric effects have been reported to persist after discontinuation of the medication.

Overdose and Emergency Response

Overdose Scope

Category Official Regulatory Statement
Documented overdose presentations No specific adverse effects were observed in human patients who received single doses of the active ingredient up to 400 mg.
Physiological systems affected (as stated in label) No specific physiological systems are explicitly listed as being affected in documented human overdose cases.
Dose-related or exposure-related factors (if applicable) No adverse effects were reported in clinical studies involving multiple doses up to 80 mg/day administered for three months.
Population-specific overdose notes (if applicable) No population-specific overdose considerations are explicitly stated within the regulatory overdose section.
Emergency-response statements (as written in official documents) Overdose management should consist of supportive care provided based on the manifestation of symptoms.
When immediate medical help is required (label-derived phrasing only) Individuals must seek immediate medical attention for a known or suspected overdose.

Overdose Classifications (High-Level)

Category Official Regulatory Statement
Severity classification (as defined in official documents) Acute toxicity is considered low, evidenced by the absence of specific adverse effects in documented high-dose human exposure.
Regulatory basis (EMA / FDA / etc.) Based on the Overdosage section of official prescribing information and the Summary of Product Characteristics (SmPC).
Overdose-context constraints (as defined in official documents) No specific treatment or antidote is recommended for the overdose.

Resulting Overdose Structure

Official overdose statements:

  • No specific adverse effects were documented in patients exposed to single doses up to 400 mg or multiple doses up to 80 mg/day for three months.
  • No specific treatment or antidote is recommended for an overdose.
  • Management of overdose requires supportive care based on the symptoms presented.
  • Immediate medical attention must be sought for a suspected or confirmed overdose.

Connection to the Overall Overdose Profile

The regulatory documents define the overdose profile primarily by the absence of specific human toxicity symptoms at high doses tested in clinical settings. This high tolerance level means that no specific antidote has been developed or recommended by regulatory authorities. Consequently, the mandated emergency-seeking condition is to contact medical services immediately, which allows for supportive care to be initiated based on any clinical manifestations that may occur.

Therapeutic Uses of Finatra

Main Uses and Applications

Finatra is primarily indicated for the treatment of androgenetic alopecia, a common form of hair loss frequently referred to as male pattern baldness. It is used to manage thinning hair at the crown and the middle of the scalp by addressing the underlying hormonal processes that contribute to follicle miniaturization.

In addition to its application in hair loss, the medication is also utilized to treat symptoms of benign prostatic hyperplasia (BPH). In this context, it helps manage urinary difficulties associated with an enlarged prostate, such as weak stream, hesitation, or the frequent urge to urinate.

Expected Benefits

Hair Regrowth and Maintenance

The primary benefit for individuals with hair loss is the potential to slow or stop further hair thinning. In many cases, users may experience a degree of regrowth in areas where follicles are still active. The treatment works by targeting the specific hormones responsible for shrinking hair follicles, allowing for the maintenance of existing hair density over time.

Management of Prostate Enlargement

For those using the medication for BPH, the main benefit is the gradual reduction in the size of the prostate gland. This can lead to a significant improvement in urinary flow and a decrease in the overall discomfort associated with urinary tract symptoms. By managing the growth of the prostate tissue, the medication helps reduce the long-term risk of complete urinary blockage.

Long-term Management

Finatra is intended for long-term use to maintain its therapeutic effects. The benefits regarding both hair density and prostate volume are typically observed after several months of consistent application, as the biological processes involved in hair growth cycles and tissue reduction require time to manifest visible changes.

Regulatory References

  1. NIH MedlinePlus overview

Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Finatra — official regulatory information

Eligibility scope

Category Official Regulatory Statement
Populations for whom use is allowed Adult Men aged 18 years and over.
Populations for whom use is not recommended Women (The medicine is not indicated for use in females).
Populations for whom use is contraindicated Women who are or may potentially be pregnant; Pediatric patients (under 18); Patients with known hypersensitivity to Finasteride.
Age-related eligibility rules Minimum age is 18 years; Geriatric patients (older adults) require no dosage adjustment.
Condition-specific eligibility rules Caution must be exercised with hepatic impairment (liver function abnormalities); Renal impairment requires no dosage adjustment.
Pregnancy and lactation eligibility status Contraindicated during pregnancy; Not indicated for use in nursing mothers.
Eligibility-related restrictions Women who are pregnant or may become pregnant must not handle crushed or broken tablets.

Eligibility classifications (high-level)

Classification Type Regulatory Statement Examples
Eligibility severity classification Contraindicated; Caution; No Dosage Adjustment Necessary.
Regulatory basis EMA Summary of Product Characteristics (SmPC) / FDA Prescribing Information.
Eligibility-context constraints Gender exclusion (limited to men); Teratogenicity risk; Age limitation.

Resulting eligibility structure

Official eligibility statements:

  • The medicine is approved exclusively for use in Adult Men aged 18 years and over.
  • Use is contraindicated in all women, especially those who are or may potentially be pregnant, due to the potential risk of abnormalities to a male fetus.
  • It is contraindicated and not indicated for use in pediatric patients as safety and efficacy have not been established.
  • Caution is formally required when administering the medicine to patients with hepatic impairment (liver function abnormalities).
  • No dosage adjustment is necessary for older adults or those with renal impairment (kidney disease).

Connection to the overall eligibility profile: The official regulatory documents define the eligibility profile for Finatra primarily through absolute contraindications based on gender and reproductive status, citing the teratogenicity risk to a male fetus as the core exclusion. The profile is further restricted by an age minimum of 18 years and includes specific cautions for use in patients with pre-existing hepatic impairment. These statements strictly limit the patient population to adult males and place explicit prohibitions on specific populations.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Finatra (fenfluramine) is associated with clinically significant drug interactions, primarily due to its effects on the serotonergic system and its metabolism by certain liver enzymes.

Contraindicated Combinations

Finatra is contraindicated for use with Monoamine Oxidase Inhibitors (MAOIs), or within 14 days of stopping an MAOI. This restriction is critical due to a greatly increased risk of a potentially life-threatening condition called Serotonin Syndrome, which results from excessive serotonin levels in the central nervous system. This warning extends to medicinal products that inhibit the MAO enzyme, such as linezolid and methylene blue.

Serotonergic Drugs

Concomitant use with other serotonergic drugs may also increase the risk of Serotonin Syndrome. These products include, but are not limited to, Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs), tricyclic antidepressants, triptans, and the opioid tramadol. Caution is advised when combining Finatra with any medicine that increases serotonin activity.

Pharmacokinetic Interactions Requiring Dose Adjustment

  • Antiepileptic Regimens: Co-administration with the combination of stiripentol and clobazam necessitates a reduced maximum daily dose of Finatra. This is because these co-administered medicines inhibit the metabolism of fenfluramine, leading to higher drug exposure in the body.
  • Strong CYP1A2 and CYP2B6 Inducers: When Finatra is taken with strong inducers of the CYP1A2 and CYP2B6 enzymes (e.g., rifampin), the plasma concentration of fenfluramine is decreased. A dosage increase of Finatra may be considered under these conditions, provided the overall maximum dose limits are respected.

Mechanism of Action

The mechanism of Finatra (Finasteride) operates through the selective inhibition of a key enzyme, resulting in the modulation of the androgen Dihydrotestosterone (DHT) and a subsequent cascade of cellular changes in sensitive tissues.

Specific Enzyme Inhibition and Androgen Modulation

Finatra selectively inhibits the Type II 5alpha-Reductase enzyme (5alpha-R2), which is highly prevalent in specific tissues, including the prostate gland and hair follicles. The active component acts as a competitive inhibitor, blocking the enzyme's function of converting Testosterone into the more potent hormone, Dihydrotestosterone (DHT). By suppressing the generation of DHT—the primary ligand driving androgen signaling in these tissues—the drug reduces the signal strength of the hormonal pathway.

Tissue-Level Homeostasis and Involution

The profound, sustained reduction in local DHT concentration reduces the primary proliferative stimulus for androgen-sensitive cells. This hormonal deprivation triggers an increase in apoptosis (programmed cell death) and a decrease in cell proliferation within the affected tissues. This mechanism modulates processes driven by distinct signaling patterns and is associated with tissue involution (a reduction in the volume or size of the cellular structures).

⏱️ Sustained Enzyme Deactivation Kinetics

Finatra's active component forms a highly stable complex with the Type II 5alpha-Reductase enzyme. This interaction means the enzyme remains functionally inhibited for an extended period, even if the drug's concentration fluctuates in the bloodstream. This kinetic property establishes a suppressed state within targeted pathways, contributing to the resulting physiological adjustments (lowered DHT and tissue-level effects) which is maintained for an extended period.

Dosage and Administration Information

How to Use Finatra — Official Administration Guidelines

The general principles for using Finatra specify high-level dosing, frequency, and administration conditions.


Administration Scope

Instruction Detail
Route of Administration The approved route is oral administration via a film-coated tablet.
Dosing Schedule BPH Management: The standard regimen is 5 mg taken once daily.
AGA Management: The standard regimen is 1 mg taken once daily.
Timing in Relation to Meals The tablet may be administered with or without meals as food intake does not affect its absorption.
Age-Group Administration Rules Older Adults (Geriatric): No dosage adjustment is necessary.
Renal Impairment: No dosage adjustment is required.
Pediatric Population: Not indicated for use in children or adolescents.
Missed-Dose Rules If a dose is missed, it should be skipped. The next dose should be taken at the usual scheduled time, and a double dose must not be taken.
Special Procedural Conditions The film-coated tablet must be swallowed whole and must not be crushed, broken, or chewed.

Instruction Classifications (High-Level)

Classification Detail
Administration Method Type Oral (tablet)
Frequency Pattern Daily (once per day)
Use-Context Constraints Duration: The regimen is structured as continuous, long-term daily use to sustain the effect. Efficacy assessment may require three to six months of administration.

Resulting Procedural Structure

Official Step Sequence:

  • The appropriate tablet strength (1 mg or 5 mg) is administered once daily.
  • The tablet is swallowed whole, regardless of the meal schedule.
  • Dosing is consistent and does not require adjustment for older adults or individuals with kidney impairment.

Connection to the Overall Use Protocol

The official instructions establish a standardized, fixed-dose, long-term oral regimen to maintain consistent physiological activity. The procedural mandate to swallow the tablet whole confirms the designed systemic delivery and integrity of the medication.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Finatra

Evidence Structure for Benign Prostatic Hyperplasia (BPH) and LUTS

The evidence base for Finasteride (Finatra) related to Benign Prostatic Hyperplasia (BPH) primarily consists of Randomized Controlled Trials (RCTs). These studies were frequently supported by large-scale systematic reviews and meta-analyses. Researchers examined outcomes related to physical discomfort and systemic or functional imbalance, including objective factors like prostate volume (PV) and the maximum speed of urinary flow. Studies monitored changes in these measures over defined time intervals, with major trials providing long-term observation data (up to seven years). Research also examined the incidence of BPH-related events, such as instances of acute urinary retention or the necessity for BPH-related surgery. Studies report that short-term symptom measurements often documented a significant response in the placebo control group as well.

Evidence Structure for Androgenetic Alopecia (AGA) (Male Pattern Hair Loss)

For Androgenetic Alopecia, the evidence structure was built upon multiple Randomized Controlled Trials (RCTs). These studies typically involved adult men aged 18 to 41 presenting with early- to moderate-stage hair loss. Research examined outcomes using standardized methods like objective hair counts, investigator assessments, and clinical photographs. Research describes patterns observed in the studies related to the stabilization or slowing of the progression of hair loss over defined observation periods, which often lasted up to five years. Studies noted that the observed patterns in hair density were associated with the continuous use, with reported values returning toward baseline if the study substance was stopped.

Research Findings in Subgroups and Special Populations

Data are still emerging or limited for men with BPH symptoms but without confirmed prostate enlargement. Subgroup findings are uncertain for individuals outside the primary populations studied: older men with established prostate enlargement (for BPH) and younger men with specific early-to-moderate patterns of hair loss (for AGA). Due to the study design focusing exclusively on men for both indications, the primary efficacy trials did not include female patients.

What the Research Evidence Does Not Yet Clarify (Uncertainty and Gaps)

A key limitation is that information on long-term effects remains limited beyond the follow-up durations of the major trials (e.g., beyond five to seven years). While official research explored short-term symptom changes, certainty remains low regarding the long-term patterns of response over extended periods of use. Furthermore, comparative evidence is lacking when looking at how Finasteride compares with all other potential management options for BPH and AGA, as not all comparisons have been studied directly in large-scale RCTs. The study results reflect the specific conditions under which they were conducted and do not determine whether an individual will respond similarly.

Key Studies & References

  1. Finasteride: MedlinePlus Drug Information
  2. Serum prostate-specific antigen and prostate volume predict long-term changes in symptoms and flow rate: results of a four-year, randomized trial comparing finasteride versus placebo (PLESS Study Group)

Frequently Asked Questions (FAQ)

Common questions about Finatra (FAQ)


Q: Can Finatra be taken with coffee or caffeine?

Official prescribing information states that Finatra may be taken with or without food. Regulatory sources may note that reducing general intake of stimulants, like caffeine, is sometimes recommended as a general management strategy for underlying urinary symptoms; however, no specific drug-caffeine interaction is noted.

Q: Is Finatra considered an over-the-counter medicine?

No. Official government labeling and resources classify the active ingredient in Finatra as a prescription-only medication. It must be prescribed by a licensed healthcare provider.

Q: Does Finatra cause weight gain or weight loss?

Regulatory documents mention that unusual weight changes, specifically rapid weight gain or loss, have been reported in some patients during clinical use or post-marketing surveillance. Reports of this effect are typically categorized as less common in regulatory documents.

Q: Is it normal to feel tired when taking Finatra?

Drowsiness or somnolence has been reported in official product information as a potential central nervous system side effect. Concerns about symptoms are typically addressed through a healthcare provider.

Q: Is Finatra a controlled substance?

No. Official government labeling and resources classify Finatra as Not a controlled drug. The drug is not scheduled by the U.S. Drug Enforcement Administration (DEA).

Q: Does Finatra interact with common pain relievers like ibuprofen?

Official product information does not list common, over-the-counter pain relievers like ibuprofen as significant drug interactions. Regulatory constraints generally emphasize the importance of communicating all prescription and nonprescription medications to the prescriber.

Q: Is there a generic version of Finatra available?

Yes. The active ingredient in Finatra, finasteride, has been approved by regulatory bodies and is widely available as a generic medicine in addition to its branded versions.

Q: Are there special warnings about driving while taking Finatra?

Finatra generally does not affect the ability to drive or use machinery. However, safety documents note that if lightheadedness or dizziness occurs, a patient's ability to drive may be affected.

Q: Can Finatra make you feel dizzy or lightheaded?

Official regulatory documents list dizziness, faintness, or lightheadedness as a common side effect, which may be associated with a change in blood pressure upon standing (postural hypotension).

Q: What should I do if I get stomach upset from Finatra?

Stomach pain and nausea have been noted in official safety documents as potential, though less common, gastrointestinal side effects. Regulatory safety documents note that bothersome symptoms are typically discussed with a healthcare provider.

Q: Are there specific foods I should avoid while on Finatra?

No specific foods must be avoided while taking Finatra. Official guidelines state that the tablet may be taken with or without food.

Q: Does Finatra change how birth control pills work?

Finasteride, the active ingredient, is generally not thought to stop any type of contraception from working. Finatra is typically not indicated for use in women, and the safety information focuses on the risk to a male fetus.

Q: Is Finatra safe for people with high blood pressure?

Postural hypotension, a drop in blood pressure upon standing, is listed as a potential common side effect, especially when Finatra is used with certain other blood pressure medications (alpha-blockers). The potential for blood pressure changes is a documented consideration in the official safety information.

Q: Can I take Finatra if I drink alcohol?

Official guidelines state that patients can generally drink alcohol while taking Finatra. However, excessive alcohol consumption is not recommended as it can negatively impact overall health and may affect the symptoms of the condition Finatra is prescribed to treat.

Q: What is the history of Finatra's approval?

The active ingredient in Finatra, finasteride, received its initial U.S. FDA approval in 1992 for the 5 mg strength and later in 1997 for the 1 mg strength, targeting its two main indications.

Q: Are there any common interactions with supplements or herbal remedies?

Official interaction guidance focuses primarily on prescription medicines. There is insufficient information to confirm that most herbal remedies or supplements are safe when combined with Finatra. Some regulatory sources note that the herbal product St. John’s wort may potentially reduce Finatra’s effectiveness.

Q: Does Finatra interact with grapefruit or grapefruit juice?

While regulatory documents discuss Finatra’s metabolism via the CYP450 enzyme system, they do not specifically list grapefruit or grapefruit juice as a known food interaction that must be avoided.

Q: Does Finatra have a black box warning?

The active ingredient in Finatra does not currently carry a U.S. FDA Black Box Warning (BBW). However, the FDA has issued label revisions to include warnings about the risk of high-grade prostate cancer and the possibility of persistent sexual adverse events.

Q: Why does the Finatra instruction sheet mention [specific warning]?

Official instructions and safety sheets carry a specific warning that women who are or may become pregnant must not handle crushed or broken tablets. This is due to the potential risk of external genital abnormalities in a male fetus from skin contact with the active ingredient.

Q: How long does it usually take for Finatra to start working?

Official product information indicates that consistent, daily use for three months or longer is often necessary before a patient can objectively notice or measure the benefits of Finatra. The full effect is generally observed with continued use.

Q: Do you have to take Finatra forever?

Continued, long-term daily use is generally recommended to sustain the effects of the medication. Official information states that if treatment is discontinued, the patient can expect a reversal of the effects, which may occur within about 12 months.

Q: Are there any long-term effects of taking Finatra?

Official post-marketing surveillance reports note that some sexual side effects (such as decreased libido and erectile dysfunction) and psychiatric effects (such as depression) have been reported to persist after the drug has been discontinued in certain patients.

Q: Does Finatra require any special lab tests before starting?

For patients being treated for Benign Prostatic Hyperplasia (BPH), regulatory documents recommend obtaining a baseline Prostate-Specific Antigen (PSA) level before treatment begins. Regulatory documents state that Finatra reduces the PSA level by approximately 50%, a factor that is to be considered during subsequent cancer screening interpretations.

Q: Is it difficult to stop taking Finatra once you've started?

Official safety data has documented the risk of certain side effects, including sexual and psychiatric effects, persisting after stopping the drug. The persistence of these effects is noted in regulatory information as a factor to be considered during discussions about discontinuing therapy.

Q: What are the signs of a serious reaction to Finatra?

Official medical information describes that serious reactions are events that require immediate medical attention. These can include changes in the breasts (lumps, pain, or discharge), signs of a severe allergic reaction like swelling of the face or lips (angioedema), or difficulty breathing or swallowing.

Q: Is a prescription necessary for Finatra?

Yes, Finatra is strictly available as a prescription-only (Rx) medication. It cannot be purchased over the counter.

Q: What's the difference between Finatra tablets and capsules (if applicable)?

According to the official product description, Finatra is supplied only as a film-coated tablet designed to be swallowed whole. The active ingredient is not available as a capsule under this name.

How should Finatra be stored and disposed of?

How to Store and Dispose of Finatra?

Finatra (Finasteride) tablets must be stored according to specific regulatory requirements to maintain product integrity and safety.


Storage Requirements

Condition Regulatory Requirement
Temperature Store at controlled room temperature, typically 20 C to 25 C (68 F to 77 F).
Protection Keep in a dry place, away from excess heat, moisture, and direct light.
Container Must be kept in the original container and kept tightly closed.

Handling and Disposal

Finatra must be kept out of the sight and reach of children. The medication must be protected from freezing. Due to the nature of the active ingredient, women who are or may become pregnant must not handle crushed or broken tablets. If contact occurs, the affected area should be washed immediately with soap and water.

Disposal of any unused or expired Finatra must be conducted in accordance with local pharmaceutical waste requirements and should not be thrown into household trash or discharged into wastewater.

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

Available in countries:

Equivalent of Finatra found in:

A-Z Index: