Finasteride

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• Finasteride tablets may be administered with or without meals.
• The recommended dose of Finasteride Tablets, USP 1 mg is one tablet (1 mg) taken once daily.
• In general, daily use for three months or more is necessary before benefit is observed.
• Continued use is recommended to sustain benefit, which should be re-evaluated periodically.
• Withdrawal of treatment leads to reversal of effect within 12 months.
• Finasteride tablets may be administered with or without meals (2).
• One tablet (1 mg) taken once daily (2).
• In general, daily use for three months or more is necessary before benefit is observed (2).

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Quoted from the official label, section “Overdosage”.

Use in children

Finasteride tablets is not indicated for use in pediatric patients. Safety and effectiveness in pediatric patients have not been established.

Quoted from the official label, section “Pediatric Use”.

Use in older people

• Clinical efficacy studies with Finasteride tablets did not include subjects aged 65 and over.
• Based on the pharmacokinetics of finasteride 5 mg, no dosage adjustment is necessary in the elderly for finasteride tablets [see Clinical Pharmacology (12.3)].
• However the efficacy of finasteride tablets in the elderly has not been established.

Quoted from the official label, section “Geriatric Use”.

Side effects

• The most common adverse reactions, reported in ≥1% of patients treated with Finasteride tablets and greater than in patients treated with placebo are:
• decreased libido, erectile dysfunction and ejaculation disorder (6.1).
• To report SUSPECTED ADVERSE REACTIONS, contact Ascend Laboratories, LLC at 1-877-ASC-RX01 (877-272-7901) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
• 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
• Clinical Studies for finasteride tablets 1 mg in the Treatment of Male Pattern Hair Loss In three controlled clinical trials for finasteride tablets of 12-month duration, 1.4% of patients taking finasteride tablets (n=945) were discontinued due to adverse experiences that were considered to be possibly, probably or definitely drug-related (1.6% for placebo; n=934).
• Clinical adverse experiences that were reported as possibly, probably or definitely drug-related in >1% of patients treated with finasteride tablets or placebo are presented in Table 1.
• TABLE 1:
• Drug-Related Adverse Experiences for Finasteride tablets 1 mg (finasteride 1 mg) in Year 1(%) MALE PATTERN HAIR LOSS Finasteride Placebo N=934 Decreased Libido 1.8
• 1.3 Erectile Dysfunction 1.3
• 0.7 Ejaculation Disorder (Decreased Volume of Ejaculate) 1.2 (0.8) 0.7 (0.4) Discontinuation due to drug-related sexual adverse experiences 1.2
• 0.9 Integrated analysis of clinical adverse experiences showed that during treatment with finasteride tablets 36 (3.8%) of 945 men had reported one or more of these adverse experiences as compared to 20 (2.1%) of 934 men treated with placebo (p=0.04).
• Resolution occurred in men who discontinued therapy with finasteride tablets due to these side effects and in most of those who continued therapy.
• The incidence of each of the above adverse experiences decreased to <0.3% by the fifth year of treatment with finasteride tablets.
• In a study of finasteride 1 mg daily in healthy men, a median decrease in ejaculate volume of 0.3 mL (11%) compared with 0.2 mL (-8%) for placebo was observed after 48 weeks of treatment.
• Two other studies showed that finasteride at 5 times the dosage of finasteride tablets (5 mg daily) produced significant median decreases of approximately 0.5 mL (-25%) compared to placebo in ejaculate volume, but this was reversible after discontinuation of treatment.
• In the clinical studies with finasteride tablets, the incidences for breast tenderness and enlargement, hypersensitivity reactions, and testicular pain in finasteride-treated patients were not different from those in patients treated with placebo.
• Controlled Clinical Trials and Long-Term Open Extension Studies for finasteride tablets (finasteride 5 mg) and AVODART (dutasteride) in the Treatment of Benign Prostatic Hyperplasia In the finasteride tablets 5 mg Long-Term Efficacy and Safety Study (PLESS), a 4-year controlled clinical study, 3040 patients between the ages of 45 and 78 with symptomatic BPH and an enlarged prostate were evaluated for safety over a period of 4 years (1524 on finasteride tablets 5 mg/day and 1516 on placebo). 3.7% (57 patients) treated with finasteride tablets 5 mg and 2.1% (32 patients) treated with placebo discontinued therapy as a result of adverse reactions related to sexual function, which are the most frequently reported adverse reactions.
• Table 2 presents the only clinical adverse reactions considered possibly, probably or definitely drug related by the investigator, for which the incidence on finasteride tablets 5 mg was >1% and greater than placebo over the 4 years of the study.
• In years 2 to 4 of the study, there was no significant difference between treatment groups in the incidences of impotence, decreased libido and ejaculation disorder.
• TABLE 2:Drug-Related Adverse Experiences for finasteride tablets 5 mg BENIGN PROSTATIC HYPERPLASIA Year 1 (%) Years 2, 3 and 4* (%) Finasteride 5 mg Placebo Finasteride 5 mg Placebo Impotence 8.1 3.7 5.1
• 5.1 Decreased Libido 6.4 3.4 2.6
• 2.6 Decreased Volume of Ejaculate 3.7 0.8 1.5
• 0.5 Ejaculation Disorder 0.8 0.1 0.2
• 0.1 Breast Enlargement 0.5 0.1 1.8
• 1.1 Breast Tenderness 0.4 0.1 0.7
• 0.3 Rash 0.5 0.2 0.5 0.1 *Combined Years 2 to 4 N = 1524 and 1516, finasteride vs placebo, respectively The adverse experience profiles in the 1-year, placebo-controlled, Phase III BPH studies and the 5-year open extensions with finasteride tablets 5 mg and PLESS were similar.
• There is no evidence of increased sexual adverse experiences with increased duration of treatment with finasteride tablets 5 mg.
• New reports of drug-related sexual adverse experiences decreased with duration of therapy.
• During the 4- to 6-year placebo- and comparator-controlled Medical Therapy of Prostatic Symptoms (MTOPS) study that enrolled 3047 men, there were 4 cases of breast cancer in men treated with finasteride tablets 5 mg but no cases in men not treated with finasteride tablets 5 mg.
• During the 4-year placebo-controlled PLESS study that enrolled 3040 men, there were 2 cases of breast cancer in placebo treated men, but no cases were reported in men treated with finasteride tablets 5 mg.
• During the 7-year placebo-controlled Prostate Cancer Prevention Trial (PCPT) that enrolled 18,882 men, there was 1 case of breast cancer in men treated with finasteride tablets, and 1 case of breast cancer in men treated with placebo.
• The relationship between long-term use of finasteride and male breast neoplasia is currently unknown.
• The PCPT trial was a 7-year randomized, double-blind, placebo-controlled trial that enrolled 18,882 healthy men ≥55 years of age with a normal digital rectal examination and a PSA ≤3.0 ng/mL.
• Men received either finasteride tablets 5 mg (finasteride 5 mg) or placebo daily.
• Patients were evaluated annually with PSA and digital rectal exams.
• Biopsies were performed for elevated PSA, an abnormal digital rectal exam, or the end of study.
• The incidence of Gleason score 8 to 10 prostate cancer was higher in men treated with finasteride (1.8%) than in those treated with placebo (1.1%).
• In a 4-year placebo controlled clinical trial with another 5α-reductase inhibitor [AVODART (dutasteride)], similar results for Gleason score 8 to 10 prostate cancer were observed (1% dutasteride vs 0.5% placebo).
• The clinical significance of these findings with respect to use of finasteride tablets by men is unknown.
• No clinical benefit has been demonstrated in patients with prostate cancer treated with finasteride tablets.
• Finasteride tablets is not approved to reduce the risk of developing prostate cancer.
• 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of finasteride tablets.
• Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure:
• Hypersensitivity Reaction:
• hypersensitivity reactions such as rash, pruritus, urticaria, and angioedema (including swelling of the lips, tongue, throat, and face);
• Reproductive System:
• sexual dysfunction that continued after discontinuation of treatment, including erectile dysfunction, libido disorders, ejaculation disorders, and orgasm disorders; male infertility and/or poor seminal quality (normalization or improvement of seminal quality has been reported after discontinuation of finasteride); testicular pain. [See Adverse Reactions (6.1).] Neoplasms:
• male breast cancer;
• Breast disorders: breast tenderness and enlargement;
• Nervous System/Psychiatric: depression

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• See FDA-approved patient labeling (Patient Information).
• 17.1 Exposure of Women — Risk to Male Fetus Physicians should inform patients that women who are pregnant or may potentially be pregnant should not handle crushed or broken Finasteride Tablets because of the possibility of absorption of finasteride and the subsequent potential risk to a male fetus.
• Finasteride Tablets are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets have not been broken or crushed.
• If a woman who is pregnant or may potentially be pregnant comes in contact with crushed or broken finasteride tablets, the contact area should be washed immediately with soap and water [see Contraindications (4), Warnings and Precautions (5.1), Use in Specific Populations (8.1) and How Supplied/Storage and Handling (16)].
• 17.2 Increased Risk of High-Grade Prostate Cancer Patients should be informed that there was an increase in high-grade prostate cancer in men treated with 5α-reductase inhibitors indicated for BPH treatment, compared to those treated with placebo in studies looking at the use of these drugs to prevent prostate cancer [see Warnings and Precautions (5.3) and Adverse Reactions (6.1)].
• 17.3 Additional Instructions Physicians should instruct their patients to promptly report any changes in their breasts such as lumps, pain or nipple discharge.
• Breast changes including breast enlargement, tenderness and neoplasm have been reported [see Adverse Reactions (6.1)].
• Physicians should instruct their patients to read the patient package insert before starting therapy with finasteride tablets and to read it again each time the prescription is renewed so that they are aware of current information for patients regarding finasteride tablets.
• The trademarks depicted herein are owned by their respective companies.
• Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, INDIA.
• Manufactured for:
• Thirty Madison, Inc. 29 West 30th New York, NY 10001 Revised:
• December 2020 Patient Information Finasteride Tablets, USP (fin NAH steh ride) Finasteride Tablets, USP is for use by MEN ONLY and should NOT be used by women or children.
• Read this Patient Information before you start taking finasteride tablets, USP and each time
• you get a refill.
• There may be new information.
• This information does not take the place of talking with your healthcare provider about your medical condition or treatment.
• What is finasteride tablets, USP? Finasteride tablets, USP is a prescription medicine used for the treatment of male pattern hair loss (androgenetic alopecia).
• It is not known if Finasteride tablets, USP works for a receding hairline on either side of and above your forehead (temporal area).
• Finasteride tablets, USP is not for use by women and children.
• Who should not take finasteride tablets, USP?
• Do not take finasteride tablets, USP
• if you:
• are pregnant or may become pregnant.
• Finasteride Tablets, USP 1 mg may harm your unborn baby. o Finasteride tablets, USP are coated and will prevent contact with the medicine during handling, as long as the tablets are not broken or crushed.
• Females who are pregnant or who may become pregnant should not come in contact with broken or crushed Finasteride tablets, USP.
• If a pregnant woman comes in contact with crushed or broken Finasteride tablets, USP, wash the contact area right away with soap and water.
• If a woman who is pregnant comes into contact with the active ingredient in Finasteride tablets, USP, a healthcare provider should be consulted. o If a woman who is pregnant with a male baby swallows or comes in contact with the medicine in finasteride tablets, USP, the male baby may be born with sex organs that are not normal. are allergic to any of the ingredients in finasteride tablets, USP.
• See the end of this leaflet for a complete list of ingredients in finasteride tablets, USP.
• What should I tell my healthcare provider before taking finasteride tablets, USP? Before taking finasteride tablets, USP, tell your healthcare provider
• if you:
• have any other medical conditions, including problems with your prostate or liver Tell your healthcare provider about all the medicines
• you take, including prescription and non- prescription medicines, vitamins, and herbal supplements.
• Know the medicines you take.
• Keep a list of them to show your healthcare provider and pharmacist when
• you get a new medicine.
• How should I take finasteride tablets, USP? Take finasteride tablets, USP exactly as your healthcare provider tells you to take it.
• You may take finasteride tablets, USP with or without food.
• If you forget to take finasteride tablets, USP, do not take an extra tablet.
• Just take the next tablet as usual.
• Finasteride tablets, USP will not work faster or better
• if you take it more than once a day.
• What are the possible side effects of Finasteride tablets, USP? decrease in your blood Prostate Specific Antigen (PSA) levels.
• Finasteride tablets, USP can affect a blood test called PSA (Prostate-Specific Antigen) for the screening of prostate cancer.
• If you have a PSA test done you should tell your healthcare provider that
• you are taking finasteride tablets, USP because finasteride tablets, USP decreases PSA levels.
• Changes in PSA levels will need to be evaluated by your healthcare provider.
• Any increase in follow-up PSA levels from their lowest point may signal the presence of prostate cancer and should be evaluated, even if the test results are still within the normal range for men not taking finasteride tablets, USP.
• You should also tell your healthcare provider
• if you have not been taking finasteride tablets, USP as prescribed because this may affect the PSA test results.
• For more information, talk to your healthcare provider.
• There may be an increased risk of a more serious form of prostate cancer in men taking finasteride at 5 times the dose of finasteride tablets, USP.
• The most common side effects of finasteride tablets, USP include:
• decrease in sex drive trouble getting or keeping an erection a decrease in the amount of semen The following have been reported in general use with finasteride tablets, USP:
• breast tenderness and enlargement.
• Tell your healthcare provider about any changes in your breasts such as lumps, pain or nipple discharge. depression; decrease in sex drive that continued after stopping the medication; allergic reactions including rash, itching, hives and swelling of the lips, tongue, throat, and face; problems with ejaculation that continued after stopping medication; testicular pain; difficulty in achieving an erection that continued after stopping the medication; male infertility and/or poor quality of semen. in rare cases, male breast cancer.
• Tell your healthcare provider
• if you have any side effect that bothers you or that does not go away.
• These are not all the possible side effects of finasteride tablets, USP.
• For more information, ask your healthcare provider or pharmacist.
• Call your doctor for medical advice about side effects.
• You may report side effects to FDA at 1-800-FDA-1088.
• How should I store Finasteride Tablets, USP 1 mg? Store finasteride tablets, USP at room temperature between 68˚F to 77˚F (20˚C to 25˚C).
• Keep Finasteride Tablets, USP 1 mg in a closed container and keep finasteride tablets, USP dry (protect from moisture).
• Keep finasteride tablets, USP and all medicines out of the reach of children.
• General information about the safe and effective use of finasteride tablets, USP.
• Medicines are sometimes prescribed for purposes other than those listed in this Patient Information leaflet.
• Do not use finasteride tablets, USP for a condition for which it was not prescribed.
• Do not give finasteride tablets, USP to other people, even if they have the same symptoms
• you have.
• It may harm them.
• This Patient Information leaflet summarizes the most important information about finasteride tablets, USP .
• If you would like more information, talk with your healthcare provider.
• You can ask your pharmacist or healthcare provider for information about finasteride tablets, USP that is written for health professionals.
• For more information go to http://www.ascendlaboratories.com or call 1-877-ASCRX01 (877-272-7901).
• What are the ingredients in finasteride tablets, USP? Active ingredient:
• Finasteride, USP.
• Inactive ingredients:
• lactose monohydrate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, lauroylmacrogol 32 glycerides, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, iron oxide red, and iron oxide yellow.
• This Patient Information has been approved by the U.S.
• Food and Drug Administration.
• Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, INDIA.
• Manufactured for:
• Thirty Madison, Inc. 29 West 30th New York, NY 10001 Revised:
• December 2020 PT 3479

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

FORMS AND STRENGTHS Finasteride tablets are reddish brown colored, 7 mm round, biconvex, film coated tablets, marked “F1” on one side and plain on other side. 1 mg tablets (3).

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• Finasteride tablets, USP 1 mg are available as reddish brown colored, 7 mm round, biconvex, film coated tablets, marked “F1” on one side and plain on other side.
• They are supplied as follows:
• 90's HDPE Container pack:
• NDC 71713-099-90 Storage and Handling
• Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].
• Preserve in a tight, light resistant container Women should not handle crushed or broken finasteride Tablets when they are pregnant or may potentially be pregnant because of the possibility of absorption of finasteride and the subsequent potential risk to a male fetus.
• Finasteride Tablets, USP 1 mg are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets are not broken or crushed [see Warnings and Precautions (5.1), Use in Specific Populations (8.1) and Patient Counseling Information (17.1)].

Quoted from the official label, section “How Supplied”.

What is in it

• Finasteride tablets contain finasteride as the active ingredient.
• Finasteride, a synthetic 4-azasteroid compound, is a specific inhibitor of steroid Type II 5α-reductase, an intracellular enzyme that converts the androgen testosterone into 5α-dihydrotestosterone (DHT).
• The chemical name of finasteride is N-tert -Butyl-3-oxo-4-aza-5α-androst-1-ene-17β-carboxamide.
• The empirical formula of finasteride is C 23 H 36 N 2 O 2 and its molecular weight is 372.55.
• Its structural formula is:
• Finasteride is a white crystalline powder with a melting point near 250°C.
• It is freely soluble in chloroform and in lower alcohol solvents but is practically insoluble in water.
• Finasteride Tablets, USP are film-coated tablets for oral administration.
• Each tablet contains 1 mg of finasteride and the following inactive ingredients:
• lactose monohydrate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, lauroylmacrogol 32 glycerides, magnesium stearate, Hypromellose, Titanium Dioxide, polyethylene glycol, Iron Oxide Red, and Iron Oxide Yellow. finasteride-stru1.jpg

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

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Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

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Same active substance

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