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PROSCAR FINASTERIDE 5 mg Tablet, Film Coated, 100-count — NDC 78206-0153-02 package photo

PROSCAR FINASTERIDE 5 mg Tablet, Film Coated, 100-count

by Organon LLC · 100 TABLET, FILM COATED in 1 BOTTLE (78206-153-02)
NDC 78206-0153-02
🏷️ FDA NDC (as labeled) 78206-153-02 billing pads the product segment with a zero
This package
Contains100-count Cost per ea$5.71 NADAC Per package$570.73 / 100 tablets Pack sizes2 compare ↓
Also priced by: Part D plans $5.84/unit — full pricing hub ↓
Also comes in: 30 tablets 78206-0153-01
Rx only Brand On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 78206-153-02
Product NDC 78206-153
11-digit billing NDC 78206015302
NCPDP billing unit EA — each (per item)
RxCUI 201961, 310346
UNII 57GNO57U7G
UPC 0378206153012
Application # NDA020180
SPL Set ID 6f988153-fc74-4ca4-b29a-111f750c4a4b
Established class (EPC) 5-alpha Reductase Inhibitor
Mechanism of action 5-alpha Reductase Inhibitors
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-06-01
Route ORAL
Dosage form TABLET, FILM COATED
Substance FINASTERIDE
GPI-14 56851030000320
GPI class Proscar
GCN Seq No 041440
GCN 30521
HICL code 006421
Ingredient (HICL) Finasteride
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q9
Therapeutic class — intermediate (HIC2) Urological Preparations
HIC3 code Q9B
Therapeutic class — specific (HIC3) Benign Prostatic Hypertrophy/Micturition Agents
AHFS code 84:16.00.00
AHFS class Cell Stimulants And Proliferants
FDB label name PROSCAR 5 MG TABLET
FDB brand name Proscar
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 78206-153-02 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 78206-0153-02. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the 5-alpha Reductase Inhibitor class.

Pharmacologic class 5-alpha Reductase Inhibitor
Drug family (ATC) Other dermatologicals, Testosterone-5-alpha reductase inhibitors
How it works 5-alpha Reductase Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerOrganon LLC
Application holderORGANON LLC A SUB OF ORGANON AND CO
FDA applicationNDA020180 (NDA)
Labeler code78206
First marketedJun 2021
Product typeHuman Prescription Drug
Portfolio70 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name PROSCAR 5 MG TABLET Ingredient Finasteride
📖 What it is MedlinePlus · NLM

Finasteride is used to treat benign prostatic hypertrophy (BPH, enlargement of the prostate gland) and male pattern hair loss (gradual thinning of the hair on the scalp, leading to a receding hairline or balding on the top of the head in men). Finasteride is in a class of medications called 5-alpha reductase inhibitors. Finasteride treats BPH by blocking the body's production of a male hormone that causes the prostate to enlarge. Finasteride treats male pattern hair loss by blocking the body's production of a male hormone in the scalp that stops hair growth.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Finasteride is used for two different conditions in men, and the brand matters. Proscar (the higher-strength tablet) is prescribed for an enlarged prostate (BPH) to ease urinary sy...
  • What exactly is finasteride used for — and which brand should I be taking?
  • It depends on what you're treating. For hair loss with Propecia, you generally need at least three months of daily use before noticing a difference — and you need to keep taking it...
  • How long will it take before I see results?
📖 Read our full Finasteride guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color Blue
ShapeFreeform
ImprintMSD;72;PROSCAR
Size7 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII LMI26O6933
    Alumina is a white powder form of aluminum oxide. It's used as a filler to add bulk to tablets and capsules, and sometimes as a thickening or anti-caking agent in powdered formulations.
  • UNII F05Q2T2JA0
    Docusate sodium is a stool softener compound that helps medicines dissolve and move through the digestive tract. It acts as a surfactant, reducing surface tension in the intestines, and also serves as a wetting agent in tablet formulations.
  • UNII L06K8R7DQK
    A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII RFW2ET671P
    Hydroxypropyl cellulose is a plant-derived thickening agent made from cellulose. It acts as a binder to hold tablet ingredients together and as a film-former to coat tablets or control how fast the medicine releases.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

13 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $5.707 $570.73 / 100 tablets
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $5.84 $583.93 / 100 tablets
NADAC price history (per ea) — tap or hover for the price & month
Jan 2026 May 2026 Jun 2026 Aug 2026 $5.717 $5.704
Flat over the last 5 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Finasteride 5 mg 00093-7355-05 Teva 500 tablets $0.068 AB Availability likely save 99%
Finasteride 5 mg 00904-6830-06 Major 1 tablet $0.068 AB Availability likely save 99%
Finasteride 5 mg 43598-0303-30 Dr 30 tablets $0.068 AB Availability likely save 99%
Finasteride 5 mg 50268-0314-15 AvPAK 1 tablet $0.068 AB Availability likely save 99%
Finasteride 5 mg 57237-0062-05 Rising 500 tablets $0.068 AB Availability likely save 99%
Finasteride 5 mg 60687-0428-01 American 1 tablet $0.068 AB Availability likely save 99%
Finasteride 5 mg 65862-0149-01 Aurobindo 100 tablets $0.068 AB Availability likely save 99%
Finasteride 5 mg 68645-0541-54 Legacy 30 tablets $0.068 AB Availability likely save 99%
Finasteride 5 mg 76282-0412-05 Exelan 500 tablets $0.068 AB Availability likely save 99%
Finasteride 5 mg 82009-0061-05 QUALLENT 500 tablets $0.068 AB Availability likely save 99%
Finasteride 5 mg 16729-0090-01 Accord 100 tablets $0.069 AB Availability likely save 99%
Proscar 5 mgthis 78206-0153-02 Organon 100 tablets $5.707 AB Availability likely —
Finasteride 5 mg 00615-8562-05 NCS 15 tablets — AB FDA listed —
Finasteride 5 mg 17856-0090-01 Atlantic 1 tablet — AB FDA listed —
Finasteride 5 mg 31722-0525-01 Camber 100 tablets — AB FDA listed —
Finasteride 5 mg 50090-1936-00 A-S 30 tablets — AB FDA listed —
Finasteride 5 mg 50090-4697-00 A-S 30 tablets — AB FDA listed —
Finasteride 5 mg 50090-6940-00 A-S 30 tablets — AB FDA listed —
Finasteride 5 mg 50090-6941-00 A-S 90 tablets — AB FDA listed —
Finasteride 5 mg 50090-7086-00 A-S 90 tablets — AB FDA listed —
Finasteride 5 mg 50090-7228-00 A-S 30 tablets — AB FDA listed —
Finasteride 5 mg 55111-0172-01 Dr. 100 tablets — AB FDA listed —
Finasteride 5 mg 55154-2639-00 Cardinal 1 tablet — AB FDA listed —
Finasteride 5 mg 55154-8083-00 Cardinal 1 tablet — AB FDA listed —
Finasteride 5 mg 63187-0265-10 Proficient 10 tablets — AB FDA listed —
Finasteride 5 mg 63629-1585-01 Bryant 100 tablets — AB FDA listed —
Finasteride 5 mg 67046-1058-03 Coupler 30 tablets — AB FDA listed —
Finasteride 5 mg 67877-0288-01 Ascend 100 tablets — AB FDA listed —
Finasteride 5 mg 68071-2999-09 NuCare 90 tablets — AB FDA listed —
Finasteride 5 mg 68071-3234-09 NuCare 90 tablets — AB FDA listed —
Finasteride 5 mg 68071-3354-09 NuCare 90 tablets — AB FDA listed —
Finasteride 5 mg 68071-3380-03 NuCare 30 tablets — AB FDA listed —
Finasteride 5 mg 68071-3417-03 NuCare 30 tablets — AB FDA listed —
Finasteride 5 mg 68071-3785-02 NuCare 120 tablets — AB FDA listed —
Finasteride 5 mg 68788-8377-01 Preferred 100 tablets — AB FDA listed —
Finasteride 5 mg 68788-8433-01 Preferred 100 tablets — AB FDA listed —
Finasteride 5 mg 68788-8749-01 Preferred 100 tablets — AB FDA listed —
Finasteride 5 mg 70518-1704-02 REMEDYREPACK 1 tablet — AB FDA listed —
Finasteride 5 mg 70518-3182-00 REMEDYREPACK 1 tablet — AB FDA listed —
Finasteride 5 mg 70518-3600-01 REMEDYREPACK 1 tablet — AB FDA listed —
Finasteride 5 mg 70518-3616-00 REMEDYREPACK 30 tablets — AB Discontinued —
Finasteride 5 mg 71205-0767-30 Proficient 30 tablets — AB FDA listed —
Finasteride 5 mg 71335-0433-01 Bryant 100 tablets — AB FDA listed —
Finasteride 5 mg 71335-1530-01 Bryant 100 tablets — AB FDA listed —
Finasteride 5 mg 71335-1634-01 Bryant 100 tablets — AB FDA listed —
Finasteride 5 mg 71335-1898-01 Bryant 100 tablets — AB FDA listed —
Finasteride 5 mg 71610-0515-60 Aphena 90 tablets — AB FDA listed —
Finasteride 5 mg 71610-0520-30 Aphena 30 tablets — AB FDA listed —
Finasteride 5 mg 72189-0542-30 Direct_Rx 30 tablets — AB FDA listed —
Finasteride 5 mg 76420-0154-30 Asclemed 30 tablets — AB FDA listed —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2021
On the market since
Jun 2021
📍
2026
Currently FDA-listed
5 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Proscar — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Proscar. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$78.4K
Claims incl. refills
267
Beneficiaries
191
Spend / beneficiary
$410.55
Spend / claim
$293.69
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for FINASTERIDE — the ingredient across all brands.

Top reported reactions

Erectile Dysfunction4,194
Fatigue4,094
Depression3,673
Anxiety3,092
Adverse Drug Reaction2,768
Dizziness2,457
Sexual Dysfunction2,398

Age at onset

Neonate8
Infant4
Child5
Adolescent6
Adult2,138
Elderly5,594

Reporter sex

59,984 reports
Male · 97%
Female · 3%
Unknown · 0%

Serious outcomes

Hospitalization16,027
Death5,093
Disabling4,322
Life-threatening2,418
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 7,349 3,115
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
78206-0153-01 30 TABLET, FILM COATED in 1 BOTTLE (78206-153-01) $5.71 / ea $171.22 2021-06-01 Active
78206-0153-02 You're viewing this 100 TABLET, FILM COATED in 1 BOTTLE (78206-153-02) $5.71 / ea $570.73 2021-06-01 Active

You're viewing the largest of 2 pack sizes for this product.

This pack effectively ties for the lowest per-ea cost of the 2 priced pack sizes ($5.71 NADAC).

Pack size FAQ

What quantity is in NDC 78206-0153-02?
NDC 78206-0153-02 is a 100-count package — 100 tablet, film coated in 1 bottle.
What is the difference between NDC 78206-0153-02 and NDC 78206-0153-01?
Both are PROSCAR FINASTERIDE 5 mg Tablet, Film Coated — the drug itself is identical. NDC 78206-0153-02 is the 100-count package, while NDC 78206-0153-01 is the 30 tablets package.
What NDC number is used to bill for this package of PROSCAR FINASTERIDE 5 mg Tablet, Film Coated?
Bill NDC 78206-0153-02 — the 11-digit billing format is 78206015302. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 206 words ▾

1 INDICATIONS AND USAGE PROSCAR, is a 5α-reductase inhibitor, indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to ( 1.1 ): Improve symptoms Reduce the risk of acute urinary retention Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy. PROSCAR administered in combination with the alpha-blocker doxazosin is indicated to reduce the risk of symptomatic progression of BPH (a confirmed ≥4 point increase in American Urological Association (AUA) symptom score) ( 1.2 ).

Limitations of Use : PROSCAR is not approved for the prevention of prostate cancer ( 1.3 ).

1.1Monotherapy PROSCAR ® is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: - Improve symptoms - Reduce the risk of acute urinary retention - Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy.

1.2Combination with Alpha-Blocker PROSCAR administered in combination with the alpha-blocker doxazosin is indicated to reduce the risk of symptomatic progression of BPH (a confirmed ≥4 point increase in American Urological Association (AUA) symptom score).

1.3Limitations of Use PROSCAR is not approved for the prevention of prostate cancer.

⏱️ Dosage and Administration 106 words ▾

2 DOSAGE AND ADMINISTRATION PROSCAR may be administered with or without meals. PROSCAR may be administered with or without meals ( 2 ). Monotherapy: One tablet (5 mg) taken once a day ( 2.1 ). Combination with Doxazosin: One tablet (5 mg) taken once a day in combination with the alpha-blocker doxazosin ( 2.2 ).

2.1Monotherapy The recommended dose of PROSCAR is one tablet (5 mg) taken once a day [see Clinical Studies (14.1) ] .

2.2Combination with Alpha-Blocker The recommended dose of PROSCAR is one tablet (5 mg) taken once a day in combination with the alpha-blocker doxazosin [see Clinical Studies (14.2) ].

💊 Dosage Forms and Strengths 30 words ▾

3 DOSAGE FORMS AND STRENGTHS 5-mg blue, modified apple-shaped, film-coated tablets, with the code MSD 72 on one side and PROSCAR on the other. 5-mg film-coated tablets ( 3 ).

⛔ Contraindications 163 words ▾

4 CONTRAINDICATIONS PROSCAR is contraindicated in the following: Hypersensitivity to any component of this medication. Pregnancy. Finasteride use is contraindicated in females when they are or may potentially be pregnant.

Because of the ability of Type II 5α-reductase inhibitors to inhibit the conversion of testosterone to 5α-dihydrotestosterone (DHT), finasteride may cause abnormalities of the external genitalia of a male fetus of a pregnant female who receives finasteride. If this drug is used during pregnancy, or if pregnancy occurs while taking this drug, the pregnant female should be apprised of the potential hazard to the male fetus. [See also Warnings and Precautions (5.3) , Use in Specific Populations (8.1) , and How Supplied/Storage and Handling (16) .] In female rats, low doses of finasteride administered during pregnancy have produced abnormalities of the external genitalia in male offspring.

Hypersensitivity to any components of this product ( 4 ). Females who are or may potentially be pregnant ( 4 , 5.3 , 8.1 , 16 ).

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS PROSCAR reduces serum prostate specific antigen (PSA) levels by approximately 50%. However, any confirmed increase in PSA while on PROSCAR may signal the presence of prostate cancer and should be evaluated, even if those values are still within the normal range for men not taking a 5α-reductase inhibitor ( 5.1 ). PROSCAR may increase the risk of high-grade prostate cancer ( 5.2 , 6.1 ).

Females should not handle crushed or broken PROSCAR tablets when they are pregnant or may potentially be pregnant due to potential risk to a male fetus ( 5.3 , 8.1 , 16 ). PROSCAR is not indicated for use in pediatric patients or females ( 5.4 , 8.1 , 8.2 , 8.4 , 12.3 ). Prior to initiating treatment with PROSCAR for BPH, consideration should be given to other urological conditions that may cause similar symptoms ( 5.6 ).

5.1Effects on Prostate Specific Antigen (PSA) and the Use of PSA in Prostate Cancer Detection In clinical studies, PROSCAR reduced serum PSA concentration by approximately 50% within six months of treatment. This decrease is predictable over the entire range of PSA values in patients with symptomatic BPH, although it may vary in individuals. For interpretation of serial PSAs in men taking PROSCAR, a new PSA baseline should be established at least six months after starting treatment and PSA monitored periodically thereafter.

Any confirmed increase from the lowest PSA value while on PROSCAR may signal the presence of prostate cancer and should be evaluated, even if PSA levels are still within the normal range for men not taking a 5α-reductase inhibitor. Non-compliance with PROSCAR therapy may also affect PSA test results. To interpret an isolated PSA value in patients treated with PROSCAR for six months or more, PSA values should be doubled for comparison with normal ranges in untreated men.

These adjustments preserve the utility of PSA to detect prostate cancer in men treated with PROSCAR. PROSCAR may also cause decreases in serum PSA in the presence of prostate cancer. The ratio of free to total PSA (percent free PSA) remains constant even under the influence of PROSCAR.

If clinicians elect to use percent free PSA as an aid in the detection of prostate cancer in men undergoing finasteride therapy, no adjustment to its value appears necessary.

5.2Increased Risk of High-Grade Prostate Cancer Men aged 55 and over with a normal digital rectal examination and PSA ≤3.0 ng/mL at baseline taking finasteride 5 mg/day in the 7-year Prostate Cancer Prevention Trial (PCPT) had an increased risk of Gleason score 8-10 prostate cancer (finasteride 1.8% vs placebo 1.1%). [See Indications and Usage (1.3) and Adverse Reactions (6.1) .] Similar results were observed in a 4-year placebo-controlled clinical trial with another 5α-reductase inhibitor (dutasteride, AVODART) (1% dutasteride vs 0.5% placebo).

5α-reductase inhibitors may increase the risk of development of high-grade prostate cancer. Whether the effect of 5α-reductase inhibitors to reduce prostate volume, or study-related factors, impacted the results of these studies has not been established.

5.3Exposure of Females — Risk to Male Fetus PROSCAR is contraindicated in pregnant females and in females who may potentially be pregnant and not indicated for use in females. Based on animal studies and the mechanism of action, PROSCAR may cause abnormal development of external genitalia in a male fetus if administered to a pregnant female. Females who are pregnant or may potentially be pregnant should not handle crushed or broken PROSCAR tablets.

PROSCAR 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 pregnant female comes in contact with crushed or broken PROSCAR tablets, the contact area should be washed immediately with soap and water. [See Contraindications (4) , Use in Specific Populations (8.1) , Clinical Pharmacology (12.1 and 12.3) , and How Supplie…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The drug-related adverse reactions, reported in ≥1% in patients treated with PROSCAR and greater than in patients treated with placebo over a 4-year study are: impotence, decreased libido, decreased volume of ejaculate, breast enlargement, breast tenderness and rash ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Organon LLC, a subsidiary of Organon & Co., at 1-844-674-3200 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical 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. 4-Year Placebo-Controlled Study (PLESS) In PLESS, 1524 patients treated with PROSCAR and 1516 patients treated with placebo were evaluated for safety over a period of 4 years. The most frequently reported adverse reactions were related to sexual function.

3.7% (57 patients) treated with PROSCAR 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 1 presents the only clinical adverse reactions considered possibly, probably or definitely drug related by the investigator, for which the incidence on PROSCAR was ≥1% and greater than placebo over the 4 years of the study. In years 2-4 of the study, there was no significant difference between treatment groups in the incidences of impotence, decreased libido and ejaculation disorder.

Table 1: Drug-Related Adverse Experiences Year 1 (%) Years 2, 3 and 4 Combined Years 2-4 (%) Finasteride Placebo Finasteride Placebo N = 1524 and 1516, finasteride vs placebo, respectively Impotence 8.1 3.7 5.1

5.1Decreased Libido 6.4 3.4 2.6

2.6Decreased Volume of Ejaculate 3.7 0.8 1.5

0.5Ejaculation Disorder 0.8 0.1 0.2

0.1Breast Enlargement 0.5 0.1 1.8

1.1Breast Tenderness 0.4 0.1 0.7

0.3Rash 0.5 0.2 0.5

0.1Phase III Studies and 5-Year Open Extensions The adverse experience profile in the 1-year, placebo-controlled, Phase III studies, the 5-year open extensions, and PLESS were similar. Medical Therapy of Prostatic Symptoms (MTOPS) Study In the MTOPS study, 3047 men with symptomatic BPH were randomized to receive PROSCAR 5 mg/day (n=768), doxazosin 4 or 8 mg/day (n=756), the combination of PROSCAR 5 mg/day and doxazosin 4 or 8 mg/day (n=786), or placebo (n=737) for 4 to 6 years. [See Clinical Studies (14.2) .] The incidence rates of drug-related adverse experiences reported by ≥2% of patients in any treatment group in the MTOPS Study are listed in Table 2 .

The individual adverse effects which occurred more frequently in the combination group compared to either drug alone were: asthenia, postural hypotension, peripheral edema, dizziness, decreased libido, rhinitis, abnormal ejaculation, impotence and abnormal sexual function (see Table 2 ). Of these, the incidence of abnormal ejaculation in patients receiving combination therapy was comparable to the sum of the incidences of this adverse experience reported for the two monotherapies. Combination therapy with finasteride and doxazosin was associated with no new clinical adverse experience.

Four patients in MTOPS reported the adverse experience breast cancer. Three of these patients were on finasteride only and one was on combination therapy. [See Long-Term Data .] The MTOPS Study was not specifically designed to make statistical comparisons between groups for reported adverse experiences. In addition, direct comparisons of safety data between the MTOPS study and previous studies of the single agents may not be appropriate based upon differences in patient population, dosage or dose regimen, and other procedural and study design elements.

Table 2: Incidence ≥2% in One or More Treatment Groups Drug-Related Clinical Adverse Experiences in MTOPS Adverse Experience Placebo…

🔄 Drug Interactions 113 words ▾

7 DRUG INTERACTIONS

7.1Cytochrome P450-Linked Drug Metabolizing Enzyme System No drug interactions of clinical importance have been identified. Finasteride does not appear to affect the cytochrome P450-linked drug metabolizing enzyme system. Compounds that have been tested in man have included antipyrine, digoxin, propranolol, theophylline, and warfarin and no clinically meaningful interactions were found.

7.2Other Concomitant Therapy Although specific interaction studies were not performed, PROSCAR was concomitantly used in clinical studies with acetaminophen, acetylsalicylic acid, α-blockers, angiotensin-converting enzyme (ACE) inhibitors, analgesics, anti-convulsants, beta-adrenergic blocking agents, diuretics, calcium channel blockers, cardiac nitrates, HMG-CoA reductase inhibitors, nonsteroidal anti-inflammatory drugs (NSAIDs), benzodiazepines, H 2 antagonists and quinolone anti-infectives without evidence of clinically significant adverse interactions.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary PROSCAR is contraindicated in pregnant females and not indicated for use in females. Based on animal studies and the mechanism of action, PROSCAR may cause abnormal development of external genitalia in a male fetus if administered to a pregnant female [see Warnings and Precautions (5.3) and Clinical Pharmacology (12.1) ]. In an embryo-fetal development study in rats, there was a dose-dependent increase in hypospadias that occurred in 3.6 to 100% of male offspring of pregnant rats administered oral finasteride during the period of major organogenesis at doses approximately 0.1 to 86 times the maximum recommended human dose (MRHD) of 5 mg/day (based on AUC at animal doses of 0.1 to 100 mg/kg/day).

Decreased prostatic and seminal vesicular weights, delayed preputial separation and transient nipple development were also observed in male offspring at oral maternal doses approximately 0.03 times the MRHD (based on AUC at animal dose of 0.03 mg/kg/day), along with decreased anogenital distance in male offspring at oral maternal doses approximately 0.003 times the MRHD (based on AUC at animal dose of 0.003 mg/kg/day). PROSCAR is a Type II 5α-reductase inhibitor that prevents conversion of testosterone to 5α-dihydrotestosterone (DHT), a hormone necessary for normal development of male genitalia.

If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the male fetus. Abnormal male genital development is an expected consequence when conversion of testosterone to 5α-dihydrotestosterone (DHT) is inhibited by 5α-reductase inhibitors. These outcomes are similar to those reported in male infants with genetic 5α-reductase deficiency.

Females could be exposed to finasteride through contact with crushed or broken PROSCAR tablets or semen from a male partner taking PROSCAR. With regard to finasteride exposure through the skin, PROSCAR tablets are coated and will prevent skin contact with finasteride during normal handling if the tablets have not been crushed or broken. Females who are pregnant or may potentially be pregnant should not handle crushed or broken PROSCAR tablets because of possible exposure of a male fetus.

With regard to potential finasteride exposure through semen, three studies have been conducted that measured finasteride concentrations in semen in men receiving PROSCAR 5 mg/day. In these studies the highest amount of finasteride in semen was estimated to be 50- to 100-fold less than the dose of finasteride (5 μg) that had no effect on circulating DHT levels in men [see Data and Clinical Pharmacology (12.3) ]. Data Human Data In 2 studies of healthy subjects (n=69) receiving PROSCAR 5 mg/day for 6-24 weeks, finasteride concentrations in semen ranged from undetectable (<0.1 ng/mL) to 10.54 ng/mL.

In an earlier study using a less sensitive assay, finasteride concentrations in semen of 16 subjects receiving PROSCAR 5 mg/day ranged from undetectable (<1.0 ng/mL) to 21 ng/mL. Using the highest semen level measured and assuming 100% absorption would be up to 105 ng per day, which is 50- to 100-fold less than the dose of finasteride (5 μg) that had no effect on circulating DHT levels in men [see Clinical Pharmacology (12.3) ] . Animal Data In an embryo-fetal development study, pregnant rats received finasteride during the period of major organogenesis (gestation days 6 to 17).

At maternal doses of oral finasteride approximately 0.1 to 86 times the maximum recommended human dose (MRHD) of 5 mg/day (based on AUC at animal doses of 0.1 to 100 mg/kg/day) there was a dose-dependent increase in hypospadias that occurred in 3.6 to 100% of male offspring. Exposure multiples were estimated using data from nonpregnant rats. Days 16 to 17 of gestation is a critical period in male fetal rats for differentiation of the external genitalia.

At oral maternal doses approximately 0.03 times the MRHD…

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary PROSCAR is contraindicated in pregnant females and not indicated for use in females. Based on animal studies and the mechanism of action, PROSCAR may cause abnormal development of external genitalia in a male fetus if administered to a pregnant female [see Warnings and Precautions (5.3) and Clinical Pharmacology (12.1) ]. In an embryo-fetal development study in rats, there was a dose-dependent increase in hypospadias that occurred in 3.6 to 100% of male offspring of pregnant rats administered oral finasteride during the period of major organogenesis at doses approximately 0.1 to 86 times the maximum recommended human dose (MRHD) of 5 mg/day (based on AUC at animal doses of 0.1 to 100 mg/kg/day).

Decreased prostatic and seminal vesicular weights, delayed preputial separation and transient nipple development were also observed in male offspring at oral maternal doses approximately 0.03 times the MRHD (based on AUC at animal dose of 0.03 mg/kg/day), along with decreased anogenital distance in male offspring at oral maternal doses approximately 0.003 times the MRHD (based on AUC at animal dose of 0.003 mg/kg/day). PROSCAR is a Type II 5α-reductase inhibitor that prevents conversion of testosterone to 5α-dihydrotestosterone (DHT), a hormone necessary for normal development of male genitalia.

If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the male fetus. Abnormal male genital development is an expected consequence when conversion of testosterone to 5α-dihydrotestosterone (DHT) is inhibited by 5α-reductase inhibitors. These outcomes are similar to those reported in male infants with genetic 5α-reductase deficiency.

Females could be exposed to finasteride through contact with crushed or broken PROSCAR tablets or semen from a male partner taking PROSCAR. With regard to finasteride exposure through the skin, PROSCAR tablets are coated and will prevent skin contact with finasteride during normal handling if the tablets have not been crushed or broken. Females who are pregnant or may potentially be pregnant should not handle crushed or broken PROSCAR tablets because of possible exposure of a male fetus.

With regard to potential finasteride exposure through semen, three studies have been conducted that measured finasteride concentrations in semen in men receiving PROSCAR 5 mg/day. In these studies the highest amount of finasteride in semen was estimated to be 50- to 100-fold less than the dose of finasteride (5 μg) that had no effect on circulating DHT levels in men [see Data and Clinical Pharmacology (12.3) ]. Data Human Data In 2 studies of healthy subjects (n=69) receiving PROSCAR 5 mg/day for 6-24 weeks, finasteride concentrations in semen ranged from undetectable (<0.1 ng/mL) to 10.54 ng/mL.

In an earlier study using a less sensitive assay, finasteride concentrations in semen of 16 subjects receiving PROSCAR 5 mg/day ranged from undetectable (<1.0 ng/mL) to 21 ng/mL. Using the highest semen level measured and assuming 100% absorption would be up to 105 ng per day, which is 50- to 100-fold less than the dose of finasteride (5 μg) that had no effect on circulating DHT levels in men [see Clinical Pharmacology (12.3) ] . Animal Data In an embryo-fetal development study, pregnant rats received finasteride during the period of major organogenesis (gestation days 6 to 17).

At maternal doses of oral finasteride approximately 0.1 to 86 times the maximum recommended human dose (MRHD) of 5 mg/day (based on AUC at animal doses of 0.1 to 100 mg/kg/day) there was a dose-dependent increase in hypospadias that occurred in 3.6 to 100% of male offspring. Exposure multiples were estimated using data from nonpregnant rats. Days 16 to 17 of gestation is a critical period in male fetal rats for differentiation of the external genitalia.

At oral maternal doses approximately 0.03 times the MRHD (based on AUC at animal dose o…

🧒 Pediatric Use 22 words ▾

8.4Pediatric Use PROSCAR is not indicated for use in pediatric patients. Safety and effectiveness in pediatric patients have not been established.

🧓 Geriatric Use 75 words ▾

8.5Geriatric Use Of the total number of subjects included in PLESS, 1480 and 105 subjects were 65 and over and 75 and over, respectively. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. No dosage adjustment is necessary in the elderly [see Clinical Pharmacology (12.3) and Clinical Studies (14) ] .

🆘 Overdosage 86 words ▾

10 OVERDOSAGE Patients have received single doses of PROSCAR up to 400 mg and multiple doses of PROSCAR up to 80 mg/day for three months without adverse effects. Until further experience is obtained, no specific treatment for an overdose with PROSCAR can be recommended. Significant lethality was observed in male and female mice at single oral doses of 1500 mg/m 2 (500 mg/kg) and in female and male rats at single oral doses of 2360 mg/m 2 (400 mg/kg) and 5900 mg/m 2 (1000 mg/kg), respectively.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The development and enlargement of the prostate gland is dependent on the potent androgen, 5α-dihydrotestosterone (DHT). Type II 5α-reductase metabolizes testosterone to DHT in the prostate gland, liver and skin. DHT induces androgenic effects by binding to androgen receptors in the cell nuclei of these organs.

Finasteride is a competitive and specific inhibitor of Type II 5α-reductase with which it slowly forms a stable enzyme complex. Turnover from this complex is extremely slow (t ½ ~ 30 days). This has been demonstrated both in vivo and in vitro .

Finasteride has no affinity for the androgen receptor. In man, the 5α-reduced steroid metabolites in blood and urine are decreased after administration of finasteride.

12.2Pharmacodynamics In man, a single 5-mg oral dose of PROSCAR produces a rapid reduction in serum DHT concentration, with the maximum effect observed 8 hours after the first dose. The suppression of DHT is maintained throughout the 24-hour dosing interval and with continued treatment. Daily dosing of PROSCAR at 5 mg/day for up to 4 years has been shown to reduce the serum DHT concentration by approximately 70%.

The median circulating level of testosterone increased by approximately 10-20% but remained within the physiologic range. In a separate study in healthy men treated with finasteride 1 mg per day (n=82) or placebo (n=69), mean circulating levels of testosterone and estradiol were increased by approximately 15% as compared to baseline, but these remained within the physiologic range. In patients receiving PROSCAR 5 mg/day, increases of about 10% were observed in luteinizing hormone (LH) and follicle-stimulating hormone (FSH), but levels remained within the normal range.

In healthy volunteers, treatment with PROSCAR did not alter the response of LH and FSH to gonadotropin-releasing hormone indicating that the hypothalamic-pituitary-testicular axis was not affected. In patients with BPH, PROSCAR has no effect on circulating levels of cortisol, prolactin, thyroid-stimulating hormone, or thyroxine. No clinically meaningful effect was observed on the plasma lipid profile (i.e., total cholesterol, low density lipoproteins, high density lipoproteins and triglycerides) or bone mineral density.

Adult males with genetically inherited Type II 5α-reductase deficiency also have decreased levels of DHT. Except for the associated urogenital defects present at birth, no other clinical abnormalities related to Type II 5α-reductase deficiency have been observed in these individuals. These individuals have a small prostate gland throughout life and do not develop BPH.

In patients with BPH treated with finasteride (1-100 mg/day) for 7-10 days prior to prostatectomy, an approximate 80% lower DHT content was measured in prostatic tissue removed at surgery, compared to placebo; testosterone tissue concentration was increased up to 10 times over pretreatment levels, relative to placebo. Intraprostatic content of PSA was also decreased. In healthy male volunteers treated with PROSCAR for 14 days, discontinuation of therapy resulted in a return of DHT levels to pretreatment levels in approximately 2 weeks.

In patients treated for three months, prostate volume, which declined by approximately 20%, returned to close to baseline value after approximately three months of discontinuation of therapy.

12.3Pharmacokinetics Absorption In a study of 15 healthy young subjects, the mean bioavailability of finasteride 5-mg tablets was 63% (range 34-108%), based on the ratio of area under the curve (AUC) relative to an intravenous (IV) reference dose. Maximum finasteride plasma concentration averaged 37 ng/mL (range, 27-49 ng/mL) and was reached 1-2 hours postdose. Bioavailability of finasteride was not affected by food.

Distribution Mean steady-state volume of distribution was 76 liters (range, 44-96 liters). Approximately 90% of circulating finasteride is bound to plasma proteins. There is a sl…

🧬 Mechanism of Action 117 words ▾

12.1Mechanism of Action The development and enlargement of the prostate gland is dependent on the potent androgen, 5α-dihydrotestosterone (DHT). Type II 5α-reductase metabolizes testosterone to DHT in the prostate gland, liver and skin. DHT induces androgenic effects by binding to androgen receptors in the cell nuclei of these organs.

Finasteride is a competitive and specific inhibitor of Type II 5α-reductase with which it slowly forms a stable enzyme complex. Turnover from this complex is extremely slow (t ½ ~ 30 days). This has been demonstrated both in vivo and in vitro .

Finasteride has no affinity for the androgen receptor. In man, the 5α-reduced steroid metabolites in blood and urine are decreased after administration of finasteride.

📦 How Supplied / Storage and Handling 114 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING PROSCAR tablets 5 mg are blue, modified apple-shaped, film-coated tablets, with the code MSD 72 on one side and PROSCAR on the other. They are supplied as follows: NDC 78206-153-01 unit of use bottles of 30 NDC 78206-153-02 unit of use bottles of 100. Storage and Handling Store at room temperatures below 30°C (86°F).

Protect from light and keep container tightly closed. Females should not handle crushed or broken PROSCAR 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 [see Warnings and Precautions (5.3) and Use in Specific Populations (8.1) ].

📦 Storage and Handling 65 words ▾

Storage and Handling Store at room temperatures below 30°C (86°F). Protect from light and keep container tightly closed. Females should not handle crushed or broken PROSCAR 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 [see Warnings and Precautions (5.3) and Use in Specific Populations (8.1) ].

📋 Description 140 words ▾

11 DESCRIPTION PROSCAR (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). Finasteride is 4-azaandrost-1-ene-17-carboxamide, N-(1,1-dimethylethyl)-3-oxo-,(5α,17ß)-. 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. PROSCAR (finasteride) tablets for oral administration are film-coated tablets that contain 5 mg of finasteride and the following inactive ingredients: hydrous lactose, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, hydroxypropyl cellulose LF, hydroxypropyl methylcellulose, titanium dioxide, magnesium stearate, talc, docusate sodium, FD&C Blue 2 aluminum lake and yellow iron oxide. image of finasteride chemical structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Patient Information ). 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, including PROSCAR, compared to those treated with placebo in studies looking at the use of these drugs to prevent prostate cancer [see Indications and Usage (1.3) , Warnings and Precautions (5.2) , and Adverse Reactions (6.1) ].

Exposure of Females — Risk to Male Fetus Physicians should inform patients that females who are pregnant or may potentially be pregnant should not handle crushed or broken PROSCAR tablets because of the possibility of absorption of finasteride and the subsequent potential risk to the male fetus. PROSCAR 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 female who is pregnant or may potentially be pregnant comes in contact with crushed or broken PROSCAR tablets, the contact area should be washed immediately with soap and water [see Contraindications (4) , Warnings and Precautions (5.3) , Use in Specific Populations (8.1) and How Supplied/Storage and Handling (16) ].

Additional Instructions Physicians should inform patients that the volume of ejaculate may be decreased in some patients during treatment with PROSCAR. This decrease does not appear to interfere with normal sexual function. However, impotence and decreased libido may occur in patients treated with PROSCAR [see Adverse Reactions (6.1) ] .

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 PROSCAR and to reread it each time the prescription is renewed so that they are aware of current information for patients regarding PROSCAR.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 78206-0152-01 · Organon 78206-0156-01 · Organon →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.