Finasterid Aurobindo

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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 Aurobindo

Quick Facts

Property Description
Active ingredient Finasteride
Form Film-coated tablet
Pharmacological class 5-alpha reductase inhibitor
General purpose Management of androgen-dependent disorders
Origin Synthetic (4-azasteroid compound)

Defining Finasterid Aurobindo: Identity and Origin

Finasterid Aurobindo is recognized as a generic, single-ingredient medicinal product, synthesized in the form of film-coated tablets for oral administration. The medicine contains Finasteride, an active compound classified chemically as a 4-azasteroid compound. As a generic formulation produced by Aurobindo Pharma, it is manufactured to contain the same active substance as the original brand, providing pharmacological equivalence. This product is designated as a Prescription Only Medicine, signifying that its use is subject to professional oversight, a requirement supported by pharmacological studies concerning systemic endocrine intervention.

Pharmacological Class and High-Level Action

The active substance, Finasteride, belongs to the pharmacological class known as a 5-alpha reductase inhibitor. This classification details the drug's mechanism of interfering with an enzyme that regulates hormone conversion. Finasteride is specifically a selective inhibitor, focusing primarily on the Type II 5alpha-reductase isoenzyme, a feature that distinguishes its action profile from less selective alternatives. This focused mechanism is clinically recognized for achieving reliable suppression of serum Dihydrotestosterone (DHT) levels.

Composition and General Purpose

Finasterid Aurobindo is composed of the single active ingredient, Finasteride, along with necessary solid pharmaceutical excipients to create a uniform, film-coated tablet for reliable oral use. The general therapeutic purpose of this medication is to address biological issues that are sensitive to the high activity of potent androgens. By consistently blocking the conversion of testosterone into the more active DHT, the medicine is utilized for managing conditions related to excessive hormonal influence in androgen-dependent tissues. The use of this drug class is well-established for supporting patients facing such disorders.

Regulatory References

  1. NCBI StatPearls
  2. MedlinePlus

What side effects are possible with Finasterid Aurobindo?

Finasteride is a medicine with a distinct safety profile defined by official regulatory documents, primarily involving effects related to the reproductive and endocrine systems.

Officially Documented Adverse Reactions

Adverse reactions are classified by frequency based on clinical trials and postmarketing reports provided to regulatory authorities. The adverse events fall into several System Organ Classes, including Reproductive system and breast disorders and Psychiatric disorders.

Frequency Classification Common Adverse Reactions Uncommon Adverse Reactions
Incidence Rate ge 1/100 to < 1/10 ge 1/1,000 to < 1/100
Adverse Effects Decreased libido, Erectile dysfunction, Ejaculation disorders Breast enlargement (gynecomastia), Breast tenderness, Rash

Serious adverse reactions documented in regulatory sources include male breast cancer and severe hypersensitivity reactions (such as angioedema). Reports also include cases of suicidal ideation and an increased incidence of high-grade prostate cancer observed in clinical trials with the 5 mg dose.

Safety Considerations and Constraints

The medicine is strictly not indicated for use in women. Regulatory safety constraints prohibit pregnant women or women of childbearing potential from handling crushed or broken tablets due to the potential risk of abnormal development in a male fetus. Time-related safety patterns note that sexual adverse effects and depression have been reported to persist after discontinuation of treatment in some cases.

Furthermore, finasteride causes a measured decrease in serum Prostate Specific Antigen (PSA) levels. This effect must be acknowledged when interpreting PSA values for prostate cancer screening purposes, as an increase in the reading while on treatment requires evaluation.

Overdose and Emergency Response

Finasterid Aurobindo Overdose and Emergency Response

The official prescribing information for Finasteride explicitly details the findings from high-dose human exposure, which forms the basis for regulatory guidance on overdose management. Clinical studies report that patients received single oral doses up to 400 mg and multiple doses of up to 80 mg daily for three months without the occurrence of adverse effects. Consequently, there are no specific clinical signs or symptoms of acute toxicity officially documented in the prescribing information at these tested exposure levels.

Due to this finding and the absence of established therapeutic procedures for overexposure, official documents state that no specific treatment for an overdose can be recommended.

Aspect of Overdose Profile Regulatory Status
Documented Manifestations No adverse effects reported at tested high doses.
Specific Antidote None specified; no specific treatment recommended.
Required Management Treatment is limited to symptomatic and supportive care.
When to Seek Help Immediate medical attention is required upon suspicion of overexposure, and individuals must contact a Poison Control Center.

The regulatory profile thus mandates that emergency help must be sought immediately following a suspected overdose, regardless of the patient's symptomatic status, to ensure professional clinical monitoring and supportive care are initiated.

Therapeutic Uses of Finasterid Aurobindo

What Finasterid Aurobindo Treats: Main Uses and Benefits

This medication is commonly used to help with two distinct, androgen-dependent conditions in men. It generally supports patients during episodes of heightened discomfort related to these conditions. The use of this medication is relevant for managing Benign Prostatic Hyperplasia (BPH) symptoms and stabilizing Male Pattern Hair Loss (Androgenetic Alopecia).

Management of Chronic Symptom Domains

This medication is applied in conditions where additional symptomatic support is needed for chronic prostate enlargement. It is commonly used to help with groups of symptoms that may become disruptive, such as a weak urinary stream, difficulty initiating urination, and the increased frequency of urination. A main therapeutic benefit is the easing of these Lower Urinary Tract Symptoms (LUTS). This provides support that helps ease the overall symptom burden, contributes to improved day-to-day comfort, and may assist with reducing the chance of major complications like acute urinary retention or the need for a procedural intervention. Finasterid is also considered relevant for easing the symptoms of progressive scalp hair thinning and receding hairline, supporting the maintenance of hair count and density.

Quick Fact: Main Uses and Benefits
Used for managing symptomatic discomfort related to prostate enlargement and progressive hair loss.
Supports general well-being and assists with maintaining functional stability in these chronic conditions.

Regulatory References

  1. NIH MedlinePlus Drug Information

Eligibility and Restrictions for Use

Finasterid Aurobindo's use is strictly defined by regulatory criteria, limiting its prescription to men and prohibiting use in several key populations, as outlined in official labeling.

Eligibility Scope

Classification Population Status
Populations for whom use is allowed: Men only, for approved indications (BPH and Male Pattern Hair Loss).
Populations for whom use is contraindicated: Women who are or may potentially be pregnant; individuals with known hypersensitivity to any drug component.
Age-related eligibility rules: Approved for adult men ( ge18 years). Safety and effectiveness are not established in pediatric patients ( <18 years).
Condition-specific eligibility rules: Caution is advised for patients with liver function abnormalities; no dosage adjustment is necessary for renal impairment.
Eligibility-related restrictions: Pregnant women must not handle crushed or broken tablets due to the potential risk of absorption.

Eligibility Classifications

Classification Type Detail
Severity classification: Contraindicated (Absolute prohibition) / Not Indicated (Use not established) / Caution (Conditional use).
Eligibility-context constraints: Exclusively for male patients; exclusion of childbearing potential in female handling/use.

Resulting Eligibility Structure

  • The medicine is explicitly contraindicated for all women, particularly those who are or may be pregnant.
  • Use is not indicated for patients under 18 years of age as safety and effectiveness are not established.
  • Caution is a formal regulatory requirement for patients presenting with liver function abnormalities.

Regulatory documents define the user population by establishing strict exclusionary criteria centered on gender, reproductive status, and age. The product is definitively limited to adult men, with absolute prohibition against use by women, structurally restricting use to a defined demographic.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Interaction scope

Category Official Regulatory Finding
Documented Interactions None identified as clinically important. Tested compounds, including antipyrine, digoxin, propranolol, theophylline, and warfarin, showed no meaningful interaction in studies.
Tested Drug Classes The medicine was co-administered in clinical trials with alpha-blockers, ACE inhibitors, analgesics, anti-convulsants, diuretics, and calcium channel blockers without evidence of clinically significant adverse interactions.
Metabolic Basis The active substance does not appear to affect the cytochrome P450-linked drug metabolizing enzyme system. However, Finasteride is metabolized by CYP3A4, and strong inhibitors or inducers of this enzyme may affect its plasma concentration.
Food & Timing No formal requirement for separation from food. The medicine may be administered with or without meals; bioavailability is not affected by food intake.
Population Notes In patients with Renal Impairment, plasma concentrations of inactive metabolites are increased, but the elimination rate of Finasteride itself remains unchanged. The effect of Hepatic Insufficiency on pharmacokinetics has not been studied.

Resulting interaction structure

Official regulatory documentation establishes that no drug interactions of clinical importance have been identified in regulatory studies. No specific co-administration restrictions are mandated. This profile is defined by the absence of a significant effect on the P450 system, formally classifying the medicine as having a minimal interaction risk with standard concomitant therapies. The absence of a food interaction means there are no required timing separation constraints for administration.

Mechanism of Action

Selective Inhibition of the 5alpha-Reductase Type II Enzyme

Finasteride functions as a specific, time-dependent inhibitor that targets the 5-alpha reductase Type II isoenzyme. This enzyme is the critical biological switch responsible for converting the precursor hormone, Testosterone, into the potent androgen, Dihydrotestosterone (DHT). The mechanism is rooted in binding to the enzyme's active site to directly block this metabolic step, thereby initiating the drug's core action within the androgen signaling pathway.

Cascade and Systemic Reduction of Potent Androgen Signaling

The molecular blockade of the enzyme initiates a cascade resulting in a significant reduction of DHT concentration both locally in target tissues and systemically in the bloodstream. This physiological consequence reduces the hormonal stimulus for cell proliferation and heightened activity in tissues that rely on potent androgen signaling. The overall mechanism is one of targeted metabolic modulation.

Dosage and Administration Information

Official Administration Guidelines

Finasterid Aurobindo is a film-coated tablet for oral use, and its administration must strictly follow standard administration guidelines. The medicine is not indicated for use in women or pediatric patients.

Indication Labeled Daily Dose Frequency Course Duration
Benign Prostatic Hyperplasia (BPH) 5 mg Once daily Long-term, continuous use
Male Pattern Hair Loss 1 mg Once daily 3 months or more for initial effect; continued use recommended to sustain benefit

Procedural Instructions

  • Route and Timing: The recommended dose, whether 1 mg or 5 mg, is taken once daily. The medicine can be administered with or without food.
  • Tablet Integrity: The film-coated tablet must be swallowed whole. Standard instructions explicitly state the tablet must not be crushed, divided, or chewed.
  • Missed Dose: If a daily dose is missed, patients should not take an extra tablet to make up the difference. The regular dosing schedule must be resumed the following day.

Use in Specific Populations

  • Renal or Hepatic Impairment: No dosage adjustment is required for patients with renal impairment. However, caution should be observed in patients with liver function abnormalities, as the drug is metabolized extensively in the liver.
  • Handling Restriction: Due to the potential risk to a male fetus, women who are pregnant or may become pregnant must not handle crushed or broken tablets.

Recent Clinical Evidence

Finasterid Aurobindo: Recent Clinical Evidence

Overview of Studies

Finasterid Aurobindo is a formulation of finasteride, which is primarily studied for the management of androgenetic alopecia (male pattern hair loss) and symptomatic benign prostatic hyperplasia (BPH) or enlarged prostate. Clinical research consistently focuses on finasteride's ability to inhibit the 5-alpha reductase enzyme, which reduces the body's concentration of dihydrotestosterone (DHT).

Studies have assessed the drug's effect on target tissues, including the prostate gland and hair follicles, over various treatment periods, often ranging from 6 months to several years. Primary endpoints in BPH trials frequently evaluate changes in prostate volume and improvements in urinary flow rate, while studies in androgenetic alopecia assess hair count and photographic evidence of hair growth.

Efficacy and Outcome Findings

Evidence from major randomized trials indicates that finasteride is associated with measurable changes in both conditions. In men with BPH, long-term use has been linked to a reduction in prostate volume and a decreased risk of developing acute urinary retention or needing surgical intervention.

For androgenetic alopecia, clinical studies demonstrated that the drug was associated with a promotion of hair growth and a slowing of further hair loss in the majority of subjects evaluated over a two-year period. Researchers note that these effects on hair count are sustained only for as long as the treatment is continued.

Safety and Tolerability Profile

The safety profile of finasteride has been extensively documented. The most frequently reported adverse events in trials included various forms of sexual dysfunction, such as decreased libido, erectile dysfunction, and changes in ejaculate volume. These events were generally reported to resolve upon discontinuation of the medication.

Post-marketing surveillance and subsequent studies have also investigated the potential for neuropsychiatric symptoms, including depression and sleep disturbances. Furthermore, researchers continue to study reports of persistent sexual, neurological, and physical symptoms sometimes referred to as 'Post-Finasteride Syndrome' (PFS), though the incidence and mechanism remain under investigation.

Key Studies & References

  1. Finasteride, 1 mg, for treatment of male androgenetic alopecia: a 5-year international experience

Frequently Asked Questions (FAQ)

Common questions about Finasterid Aurobindo (FAQ)


Q: What is the difference between Finasterid Aurobindo and other brands of finasteride?

A: Finasterid Aurobindo is described as a generic version of the medicine finasteride. Generic medicines contain the identical active substance as the original brand-name product. Regulatory standards require generics to be bioequivalent, meaning they work the same way in the body as the brand-name product.


Q: What happens if I stop taking Finasterid Aurobindo after a long time?

A: According to official product information, when treatment is stopped, the body’s levels of the target hormone (DHT) return to pre-treatment levels within about two weeks. For male pattern hair loss, any benefits gained are generally lost within 12 months. For an enlarged prostate, the prostate volume typically returns to its size before treatment began within three months after stopping the medicine.


Q: Is it true that Finasterid Aurobindo can cause a decrease in sex drive (libido)?

A: Yes, official regulatory documents list a decrease in libido (sex drive) as a common adverse reaction associated with finasteride use. Common reactions are those reported in clinical trials by a certain percentage of patients.


Q: Do the sexual side effects of Finasterid Aurobindo go away after stopping the medication?

A: In clinical trials, these effects were generally reported to resolve after stopping the medicine. However, official post-marketing reports also include cases where sexual dysfunction, such as decreased libido and erectile dysfunction, has been reported to persist after discontinuation of treatment in some individuals.


Q: Can Finasterid Aurobindo affect mood or cause feelings of depression?

A: Official regulatory documents include cases of psychiatric disorders, specifically depression and suicidal ideation, reported during the use of finasteride. Concerns regarding mood changes or feelings of depression should be discussed with a healthcare professional.


Q: Does taking Finasterid Aurobindo affect the results of the PSA (Prostate Specific Antigen) blood test?

A: Yes, finasteride is known to reduce serum PSA levels by about 50% after a period of use. This reduction must be considered when evaluating PSA results for prostate health screening. The healthcare professional accounts for this reduction when interpreting the PSA results.


Q: Is there a risk of developing male breast changes (such as lumps or swelling) while using Finasterid Aurobindo?

A: Regulatory documents list breast enlargement (gynecomastia) and breast tenderness as uncommon adverse reactions. Furthermore, rare cases of male breast cancer have been reported in post-marketing experience. Any changes to the breast are noted in regulatory information as requiring medical evaluation.


Q: What should I do if the side effects of Finasterid Aurobindo do not go away?

A: If any side effects persist or are a cause for concern, regulatory guidance advises reporting suspected adverse reactions. Such events are typically discussed with a healthcare professional, as regulatory guidance advises reporting persistent suspected adverse reactions for continued safety monitoring.


Q: How quickly can a person expect to see results for hair loss with this medicine?

A: Clinical studies indicate that continuous daily use for a minimum of three months is generally needed before any initial benefit is observed for hair loss. Continued treatment is necessary to sustain the positive effect, with maximum benefit often taking up to 12 months.


Q: Will Finasterid Aurobindo stop my hair loss completely?

A: In clinical trials for male pattern hair loss, the drug was associated with increased hair growth and slowing of further hair loss in the majority of subjects. Official documents describe a maintenance or improvement of hair count but do not make claims that the medicine will stop all hair loss entirely.


Q: Are there any long-term health concerns associated with using Finasterid Aurobindo?

A: Finasteride is intended for long-term use for both of its approved conditions. Official warnings focus on the potential for sexual and psychiatric side effects to persist after stopping the medicine, the risk of high-grade prostate cancer (with the 5 mg dose), and the rare risk of male breast cancer.


Q: Can Finasterid Aurobindo affect a man's fertility or sperm quality?

A: Post-marketing experience has included reports of male infertility and/or poor seminal quality in some men taking finasteride. Regulatory documents note that improvement in seminal quality has been reported after stopping the medication.


Q: Does Finasterid Aurobindo cause weight gain?

A: Clinical trial data lists 'Peripheral Edema' (swelling) as a reported adverse event. However, regulatory labels do not specifically list 'weight gain' as a common or uncommon adverse reaction associated with the medicine.


Q: Can Finasterid Aurobindo be taken by men who are older than 65?

A: For the 5 mg strength (used for enlarged prostate), clinical data indicates no overall differences in safety or efficacy were observed in men over 65 years of age. However, for the 1 mg strength (used for hair loss), specific clinical studies in men over 65 have not been established.


Q: Is Finasterid Aurobindo effective for a receding hairline, or just the crown?

A: Clinical trials for male pattern hair loss included men with baldness ranging from a receding hairline to thinning on the crown. The medicine is indicated for male pattern hair loss (androgenetic alopecia) generally and is not formally restricted to only one area of the scalp.


Q: How long does the medicine stay in the body after the last tablet is taken?

A: The active substance finasteride is quickly cleared from the bloodstream. Official pharmacokinetic data indicates the medicine has an average elimination half-life of approximately 5 to 6 hours in the body.


Q: Is Finasterid Aurobindo effective for hair loss that is not male pattern baldness?

A: Finasterid Aurobindo is only indicated for the treatment of male pattern hair loss (androgenetic alopecia) and symptomatic benign prostatic hyperplasia. Its effectiveness has not been established for other forms of hair loss.


Q: How long does it typically take for enlarged prostate symptoms to improve with this medicine?

A: Although the medicine quickly begins to reduce the target hormone (DHT), clinically meaningful improvements in enlarged prostate symptoms generally require continuous daily use for 3 to 6 months. The maximum therapeutic benefit may often take 12 months of treatment.


Q: What is the risk of developing a more serious form of prostate cancer with Finasterid Aurobindo?

A: Clinical studies involving the 5 mg dose showed an increased rate of high-grade prostate cancer (Gleason score 7–10) in men receiving finasteride compared to those receiving placebo. This is a specific warning noted in official regulatory documents.


Q: Is Finasterid Aurobindo safe for individuals who have liver problems?

A: The medicine is extensively processed in the liver. Official documents advise that caution should be observed in patients with liver function abnormalities, as the effect of liver problems on the medicine's body processing has not been extensively studied.


Q: Is Finasterid Aurobindo known to cause 'brain fog' or changes in concentration?

A: Post-marketing surveillance and safety reports have included reports of neurological and psychiatric symptoms, such as impaired concentration and reduced cognitive function, though these are not listed as common adverse reactions.


Q: Can the sexual side effects of Finasterid Aurobindo be permanent?

A: Post-marketing experience has included reports of sexual dysfunction (such as decreased libido and erectile dysfunction) that continued after the discontinuation of treatment in some cases. This indicates the possibility of persistent symptoms.


Q: What are the physical appearance (color, shape) of the Finasterid Aurobindo tablets?

A: The physical characteristics of the tablets are included in the official Prescribing Information. For example, the 5 mg tablet is typically described as a blue, circular, biconvex, film-coated tablet, although the exact color, shape, and markings can vary by the specific dose or region.


Q: Are there different versions of Finasterid Aurobindo for hair loss versus enlarged prostate?

A: Finasterid Aurobindo is available in two different strengths for its two indications. A 5 mg tablet is used for the treatment of enlarged prostate (BPH), and a 1 mg tablet is used for the treatment of male pattern hair loss.


Q: What are the inactive ingredients in Finasterid Aurobindo tablets?

A: A complete list of inactive ingredients, also known as excipients, is included in the full regulatory Prescribing Information. These are the substances—such as lactose, cellulose, and coating materials—that combine with the active ingredient to form the final tablet.


Q: Are there any reported interactions with herbal supplements like St. John's Wort?

A: Official clinical interaction studies are not reported for many herbal supplements. Finasteride is metabolized by a liver enzyme called CYP3A4, so herbal supplements like St. John's Wort that affect this enzyme may potentially influence the concentration of the medicine in the body.


Q: What are the common signs of an allergic reaction to Finasterid Aurobindo?

A: Signs of a hypersensitivity reaction reported in post-marketing experience include common allergic symptoms like rash, itching, and hives. More severe reactions like angioedema (swelling of the face, tongue, lips, and throat) have also been reported.


Q: Is a prescription required to obtain Finasterid Aurobindo?

A: Yes, Finasterid Aurobindo is classified as a Prescription Only Medicine. This means it must be obtained with a valid prescription from a licensed healthcare provider.

How should Finasterid Aurobindo be stored and disposed of?

How to Store and Dispose of Finasteride Aurobindo

Finasteride film-coated tablets generally do not require any special storage conditions to maintain their labeled shelf life. The primary requirements concern safety and proper handling.

Mandatory Storage and Handling

Storage Component Official Requirement
Child Safety Keep out of the sight and reach of children.
Environmental No specific temperature, light, or moisture restrictions are specified.
Handling Precaution Pregnant women must not handle crushed or broken tablets. The film-coating is the intended protection against contact with the active ingredient during normal use.

Disposal

Any unused or expired Finasteride Aurobindo product or waste material must be disposed of in accordance with local requirements for pharmaceutical waste. Disposal should not occur via household wastewater or general trash unless explicitly directed by local regulations.

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

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