Finasterid STADA

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Finasterid STADA

The medicinal product Finasterid STADA is a prescription-only synthetic pharmaceutical containing the active ingredient, Finasteride, delivered in the form of an oral, film-coated tablet. The product is supplied by STADA Arzneimittel AG, a prominent European pharmaceutical company.

Property Description
Active ingredient Finasteride
Form Oral, film-coated tablet
Pharmacological class 5alpha-Reductase Inhibitor
Common use Modulating effects related to DHT
Origin Synthetic, 4-azasteroid

What Pharmacological Class Does Finasteride Belong To?

Finasteride is definitively classified as a 5alpha-Reductase Inhibitor. This classification specifies that the drug's mechanism involves blocking the function of the intracellular enzyme, 5-alpha-reductase. This targeted inhibition prevents the crucial metabolic step of converting the hormone Testosterone into the more potent androgen, 5alpha-dihydrotestosterone (DHT).

The compound is recognized for its high selectivity, acting as a competitive inhibitor primarily targeting the Type II isoenzyme of 5-alpha-reductase. The substance is chemically a synthetic 4-azasteroid compound.

Finasteride Composition and General Purpose

The composition of Finasterid STADA centers exclusively on the Finasteride molecule, which constitutes the single active ingredient. The core function of Finasteride is to suppress systemic and local levels of DHT by inhibiting the relevant enzyme. This reduction in the concentration of the potent androgen DHT is the fundamental principle that drives the medication's intended general purpose: to mitigate adverse physiological processes in adult males that are known to be sensitive or responsive to excessive DHT activity.

Regulatory References

  1. Finasteride EPAR/Monograph
  2. Finasteride Mechanism of Action (NIH)

What side effects are possible with Finasterid STADA?

Finasterid STADA's safety profile details documented adverse reactions, which are classified by their frequency and the system-organ class affected, according to official regulatory documentation.

Frequency-Classified Adverse Reactions

The most commonly reported adverse reactions, classified as Common (affecting 1 to 10 users in 100), include decreased libido, erectile dysfunction, and ejaculation disorders. Reactions classified as Uncommon (affecting 1 to 10 users in 1,000) include rash and breast tenderness and/or enlargement (gynaecomastia). Post-marketing surveillance has identified additional effects categorized as Frequency Not Known, such as depression, testicular pain, palpitations, and male infertility.

Safety Considerations and Constraints

Adverse events are generally grouped within Reproductive System and Psychiatric Disorders. The official safety documents list serious reactions, including reports of male breast cancer and severe hypersensitivity reactions like angioedema.

Time-Related Patterns: Sexual adverse effects are often more frequent at the start of treatment, with incidence possibly decreasing over time. However, reports of persistent sexual dysfunction have been received following treatment cessation.

Special Populations and Constraints: The medicine is contraindicated in women who are or may become pregnant due to the risk of causing external genitalia abnormalities in a male fetus. The drug significantly reduces serum Prostate Specific Antigen (PSA) levels, which requires clinical adjustment when interpreting PSA values for prostate cancer detection.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory profile for finasteride is characterized by the absence of a defined acute toxic syndrome, even following high-dose exposure.

Domain Official Regulatory Statement
Documented Overdose Presentations No specific, unique adverse reactions or signs have been documented in regulatory labeling following single doses up to 400 mg or multiple doses up to 80 mg/day administered to human volunteers.
Physiological Systems Affected Not specified in the context of acute overdose. Regulators require immediate medical advice if depressed mood, depression, or suicidal ideation is experienced.
Dose-Related Factors Overdose exposure in clinical trials at levels significantly exceeding therapeutic doses did not result in unique severe effects.
Population-Specific Notes The effect of hepatic insufficiency on pharmacokinetics has not been studied; finasteride is extensively metabolized in the liver, which is a consideration for patients with liver function abnormalities.

Official Emergency Response

  • Required Immediate Action: In the event of a known or suspected overdose, the prescribing information mandates that immediate medical attention should be sought.
  • Supportive Measures: Management is defined as symptomatic and supportive treatment, as no specific antidote is known for finasteride overdose.
  • Procedural Consideration: Standard measures to reduce systemic absorption, such as gastric lavage or the administration of activated charcoal, may be considered.

The resulting overdose profile relies on general emergency principles. Immediate medical attention is required for any suspected overdose, and care is limited to supportive measures. Furthermore, developing or worsening psychiatric symptoms is defined by regulatory bodies as an urgent help-seeking condition requiring immediate medical advice.

Therapeutic Uses of Finasterid STADA

What Finasterid STADA Treats: Main Uses and Benefits

Finasterid STADA is commonly used across therapeutic areas where supportive management of specific, disruptive symptoms is needed. The two primary therapeutic domains it is commonly considered relevant for managing include Benign Prostatic Hyperplasia (BPH) and Male Pattern Hair Loss (Androgenetic Alopecia).

This medication is applied in clinical settings that involve acute or unstable symptom patterns. For BPH, it helps manage symptoms that create noticeable physiological strain, such as urinary frequency and difficulty initiating flow. For hair loss, it is applied in addressing symptom clusters that may become intense or disruptive, such as the gradual thinning of hair on the scalp.

This supportive therapeutic approach may assist with maintaining functional stability and can contribute to improved comfort during periods of heightened symptoms. As a general principle, it may be part of symptomatic management in situations where patients experience distressing manifestations that interfere with daily functioning.


Quick Fact: Use in Symptomatic Urinary Domains Finasterid STADA may be part of symptomatic management for groups of urinary symptoms associated with an enlarged prostate.


The medication offers symptomatic relief that supports patients during difficult episodes by easing distress associated with these conditions.

Regulatory References

  1. NIH MedlinePlus overview

Eligibility and Restrictions for Use

Finasterid STADA is indicated for use in men only and its eligibility profile is strictly defined by regulatory documents based on gender, age, and specific health conditions.

Contraindicated Populations

The medicine must not be used by the following groups:

  • Women (absolute contraindication).
  • Children and Adolescents (patients under 18 years of age, as safety and efficacy are not established).
  • Pregnant Women or those who may become pregnant (due to the potential risk of external genital abnormalities in a male fetus).
  • Patients with known hypersensitivity to the active substance Finasteride or any excipients (e.g., those with rare hereditary lactose intolerance).

Eligibility Rules by Population

Population Official Regulatory Status
Adult Men Approved for use.
Men Aged 18–41 Efficacy is primarily established for male pattern hair loss in this range.
Elderly Patients Use is permitted; no dosage adjustment is required.
Renal Impairment Use is permitted; no dosage adjustment is required, even in severe cases.
Hepatic Impairment Use with caution, as the effect on drug metabolism has not been studied.

Women who are pregnant or may become pregnant are advised not to handle crushed or broken Finasterid STADA tablets, as the drug can be absorbed through the skin, presenting a potential risk to a male fetus. The use of this drug is not indicated for women who are breastfeeding.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documents emphasize the low potential for Finasterid STADA to affect the clearance of co-administered medicines.

Interaction-Related Restrictions and Constraints

Classification Rule/Constraint Regulatory Basis
Formal Prohibition Finasterid STADA should not be co-administered with other 5alpha-reductase inhibitors (e.g., dutasteride), nor with the higher 5 mg dose of finasteride. EMA-aligned SmPC
With Food The product can be taken with or without food, as absorption is not significantly affected. EMA-aligned SmPC

Metabolic and Tested Substances

Finasteride is primarily metabolized via the Cytochrome P450 3A4 (CYP3A4) enzyme subfamily. Regulatory information states that finasteride does not appear to significantly affect the P450-linked system, limiting its potential to alter the metabolism of other drugs.

No clinically meaningful interactions were identified in studies with numerous tested compounds, including the following substances: Digoxin, Warfarin, Propranolol, Theophylline, Antipyrine (Phenazone), and Glibenclamide.

Population-Specific Pharmacokinetic Notes

Population Interaction Note Official Constraint
Hepatic Impairment Caution is advised, as finasteride is extensively metabolized in the liver, and plasma concentrations may be increased. EMA/FDA Label
Renal Impairment No dosage adjustment is necessary, even in patients with chronic renal impairment (e.g., creatinine clearances down to 9 mL/min). EMA/FDA Label

Connection to the overall interaction profile: The official regulatory profile is structured around the finding of a generally low risk for clinically significant drug-drug interactions, particularly due to the product's negligible effect on the overall CYP450 enzyme system. The primary interaction constraints documented by authorities are the formal prohibition against concurrent use with other 5alpha-reductase inhibitors and the need for caution in the context of decreased liver function.

Mechanism of Action

How Finasterid STADA Works

Highly Selective Targeting of Androgen Metabolism

Finasteride functions as a competitive, slow-binding inhibitor exhibiting high affinity for the 5-alpha-Reductase Type II enzyme. This molecular interaction interrupts the metabolic cascade that converts Testosterone into the androgen Dihydrotestosterone ( DHT). This process results in the suppression of DHT levels throughout the body (approximately 70% serum reduction), which is especially pronounced in tissues that highly express the Type II isoform.


Modulating Androgen-Dependent Tissue Remodeling

The reduction of DHT subsequently lowers the trophic signal transmitted via the Androgen Receptors (AR) in cell nuclei. This diminished signaling causes the affected tissue to undergo atrophy (shrinkage) or modulates the DHT-driven process affecting hair follicle morphology. Since these are structural changes, the ultimate physiological effect requires continuous modulation over an extended period.


Mechanistic Constraints

Finasteride primarily targets the Type II isoform; its minimal inhibition of the Type I isoform explains why total systemic DHT suppression is not complete. The delay between molecular blockade and the resulting tissue-level consequences is due to its reliance on slow, natural cellular turnover rates.

Dosage and Administration Information

How to Use Finasteride STADA — Official Administration Guidelines

Finasteride STADA is for oral administration and must be used strictly according to the official instructions provided in the package leaflet or by a healthcare professional. Adherence to the prescribed strength and schedule is essential for proper use.


Dosing and Frequency

The standard dosing regimen is once daily (one tablet per day). The required strength depends on the condition being addressed:

Condition Standard Labeled Daily Dose
Benign Prostatic Hyperplasia (BPH) 5 mg tablet
Male Pattern Hair Loss 1 mg tablet

Administration Conditions

  • With or Without Food: Finasteride STADA may be taken with or without meals. It may be beneficial to take the tablet at approximately the same time each day to maintain stable levels.
  • Tablet Handling: The tablet must be swallowed whole. It is officially stated that the tablet must not be crushed, broken, or chewed.

Special Procedural and Population Rules

  • Pregnant Women Handling Restriction: Intact tablets are coated; however, pregnant or potentially pregnant women must not handle crushed or broken finasteride tablets. This instruction is critical to prevent absorption and potential risk to a male fetus.
  • Renal or Geriatric Patients: No dosage adjustment is necessary for patients with renal impairment or for elderly patients (age 70 years and over).
  • Missed Dose: If a dose is missed, the patient should not take a double dose to compensate. The next tablet should be taken at the regularly scheduled time.

Note: Continued daily use for several months is generally required to determine treatment effectiveness, as specified for both indications.

Recent Clinical Evidence

Finasterid STADA contains the active substance finasteride, which has been studied extensively in clinical trials for two primary conditions in men: benign prostatic hyperplasia (BPH) and male pattern hair loss (androgenetic alopecia).

Evidence for Benign Prostatic Hyperplasia (BPH)

The 5 mg strength of finasteride has been researched for the management of BPH. Long-term, placebo-controlled studies involving men with symptomatic BPH and an enlarged prostate have documented the effects of the medication over several years.

  • Symptom Scores: Clinical data indicate a greater reduction in urinary symptom scores (such as the International Prostate Symptom Score, IPSS) with finasteride compared to placebo, an effect that has been noted to be sustained over four years of continuous observation.
  • Prostate Volume and Urinary Flow: Studies have observed that finasteride is associated with a reduction in prostate volume and an increase in maximum urinary flow rates in men with BPH. Data also suggest that the use of finasteride may be associated with a reduced incidence of acute urinary retention and the need for BPH-related surgery over long-term follow-up.

Evidence for Male Pattern Hair Loss

The 1 mg strength of finasteride is the dosage primarily studied and documented for the treatment of male pattern hair loss.

  • Hair Count and Density: Clinical trials have demonstrated that, compared to placebo, finasteride is associated with an increase in scalp hair count, particularly in the vertex (crown) and mid-scalp areas. For most men, a period of at least three to six months of use was necessary before any change in hair count or hair loss progression was documented. Continuous use has been observed to be necessary to maintain any sustained changes.
  • Long-term Observation: Across long-term clinical research, a large percentage of men with mild-to-moderate hair loss who used finasteride maintained or showed improvement in hair density over several years of observation.

Frequently Asked Questions (FAQ)

Common questions about Finasterid STADA (FAQ)


Q: Is Finasterid STADA the same type of medicine as Propecia or Proscar?

A: Finasterid STADA contains the active ingredient finasteride. This is the same medicine found in the brand-name products Propecia and Proscar. Medicines containing the same active substance are classified as the same type of medicine, though non-active components may differ.

Q: Is Finasterid STADA a generic medicine?

A: Finasterid STADA is manufactured by STADA Arzneimittel AG. A product marketed under the active ingredient name, such as Finasterid STADA, is generally regarded as a generic version. A generic product is regulated to contain the same active ingredient as the original brand-name drug.

Q: Is Finasterid STADA considered a long-term treatment?

A: Official information indicates that Finasteride is generally intended for the long-term management of the conditions it addresses. Studies emphasize that continuous daily use is necessary to maintain any observed reduction in symptoms or clinical benefits.

Q: How quickly is Finasterid STADA eliminated from the body?

A: The time it takes for the body to clear half of the drug (the terminal half-life) is approximately 5 to 6 hours for adult men between 18 and 60 years old. For elderly men (over 70 years), this half-life is described as slightly longer, at about 8 hours.

Q: What should I do if I suspect an interaction with Finasterid STADA and another drug?

A: Official patient materials indicate that if there is a suspicion of an interaction, consulting a doctor or a pharmacist for guidance is appropriate. A healthcare professional can provide clarification regarding your specific circumstances based on the product’s regulatory information.

Q: Does the medication have a Black Box Warning in official regulatory documents?

A: The US FDA label requires a Boxed Warning for 5-alpha reductase inhibitors, including finasteride (specifically the 5 mg strength). This warning highlights an increased risk of high-grade prostate cancer observed in some long-term clinical trials with the drug class.

Q: How long after starting Finasterid STADA do people typically notice a change?

A: Documented evidence indicates that treatment takes time to produce effects. Continuous daily use for a period of several months, typically at least three to six months, is necessary before any clinical change or potential benefit can be reliably documented or measured.

Q: Are there any known interactions with herbal supplements and Finasterid STADA?

A: Specific studies with most herbal supplements have not been conducted. However, some regulatory bodies have advised that certain herbal supplements might potentially affect the medicine's performance. It is generally advised to inform a healthcare professional about all supplements being used.

Q: Is it safe to take Finasterid STADA with alcohol?

A: Official product information does not include a formal restriction against moderate consumption of alcohol while taking this medicine. However, because finasteride is metabolized in the liver, and alcohol can place stress on the liver, it may be helpful to discuss alcohol intake with a healthcare professional.

Q: What happens if you stop taking Finasterid STADA?

A: Official documentation indicates that the positive effects of the treatment, such as reduced hair loss or smaller prostate volume, are generally expected to gradually reverse upon cessation. The underlying condition the medicine addresses is expected to return over time. Reports of persistent sexual dysfunction have also been noted following discontinuation.

Q: Are there any warnings about Finasterid STADA and mood changes?

A: Official warnings and post-marketing surveillance reports note an association with mood changes. This includes reports of depressed mood, depression, and, in rare instances, suicidal ideation. Consulting a doctor is appropriate if these types of symptoms are noticed.

Q: Is it normal to experience headache when starting Finasterid STADA?

A: Headache is not classified among the most common adverse reactions in the official product labeling. However, some clinical reports and patient documents have included headache as a potential side effect associated with the use of the medicine.

Q: Is Finasterid STADA described as a cure for the condition it treats?

A: Official regulatory documents describe the drug for the management and treatment of the conditions it addresses. These documents focus on continuous use being required to maintain benefits. The term 'cure' is not used in the official description of the drug's purpose.

Q: Do all side effects occur immediately, or can they develop later?

A: Side effects can appear at different times during the course of treatment. Official information notes that sexual adverse effects are often more frequent early on. However, other effects have been identified through post-marketing reports and may potentially develop at a later stage.

How should Finasterid STADA be stored and disposed of?

Storage Conditions

Finasteride tablets must be stored according to regulatory requirements to ensure product stability:

Requirement Official Rule
Temperature Store not above 30 C (86 F) [1.4].
Protection Protect from excess heat and moisture [2.5].
Container Keep in the original package and keep the container tightly closed [1.4, 2.5].
Child Safety Keep strictly out of the sight and reach of children [1.4, 2.5].

Handling and Disposal

Official labeling mandates specific handling and disposal procedures:

  • Handling Restriction: Women who are or may be pregnant must not handle crushed or broken tablets due to the possibility of finasteride absorption [1.1, 1.4]. The tablets are film-coated to prevent contact during normal handling [1.1, 1.4].
  • Disposal Rule: Do not dispose of Finasteride via wastewater or ordinary household trash [1.4, 1.9].
  • Proper Procedure: Consult a pharmacist for instructions on how to properly discard unused or expired medicine in line with environmental protection guidelines [1.4, 1.9].

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

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