proscar
Pharmaranks rates Proscar 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Proscar (Finasteride) is a 5-alpha reductase inhibitor used to treat Alopecia, Hirsutism, Prostatic Hyperplasia, Prostatic Neoplasms.
Finasteride · by Organon
Available as a generic: Finasteride
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Finasteride
- Drug class
- 5-Alpha Reductase Inhibitor
- Form
- Tablet
- Strength
- Finasteride 5MG
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- alopecia, hirsutism, prostatic hyperplasia
- Manufacturer
- Organon
- Half-life
- about 5 to 6 hours in men aged 18 to 60 (mean terminal half-life; after IV dosing the label reports a mean of 4.5 hours, range 3.3 to 13.4 hours) (how long it stays in your system)
- What the pharmacy pays
- ~$2.07 for 30 — not your price
- FDA application
- NDA020180
What is Proscar?
From the FDA label: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
How to use
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 ). 2.1 Monotherapy The recommended dose of PROSCAR is one tablet (5 mg) taken once a day [see Clinical Studies (14.1) ] . 2.2 Combination 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) ].
Side effects
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. 6.1 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. 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…
Warnings
Important safety information
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 ). 5.1 Effects 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. 5.2 Increased 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. 5.3 Exposure 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 Supplied/Storage and Handling (16) .] 5.4 Pediatric Patients and Females PROSCAR is not indicated for use in pediatric patients [see Use in Specific Populations (8.4) and Clinical Pharmacology (12.3) ] or females [see also Warnings and Precautions (5.3) , Use in Specific Populations (8.1) , Clinical Pharmacology (12.3) , and How Supplied/Storage and Handling (16) ]. 5.5 Effect on Semen Characteristics Treatment with PROSCAR for 24 weeks to evaluate semen parameters in healthy male volunteers revealed no clinically meaningful effects on sperm concentration, mobility, morphology, or pH. A 0.6 mL (22.1%) median decrease in ejaculate volume with a concomitant reduction in total sperm per ejaculate was observed. These parameters remained within the normal range and were reversible upon discontinuation of therapy with an average time to return to baseline of 84 weeks. 5.6 Consideration of Other Urological Conditions Prior to initiating treatment with PROSCAR, consideration should be given to other urological conditions that may cause similar symptoms. In addition, prostate cancer and BPH may coexist. Patients with large residual urinary volume and/or severely diminished urinary flow should be carefully monitored for obstructive uropathy. These patients may not be candidates for finasteride therapy.
Who should not take Proscar
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 ).
Overdose — what happens if you take too much
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.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
7.1 Cytochrome 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. 7.2 Other 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.
How long does Finasteride stay in your body?
The elimination half-life of finasteride is about 5 to 6 hours in men aged 18 to 60 (mean terminal half-life; after IV dosing the label reports a mean of 4.5 hours, range 3.3 to 13.4 hours) — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. This is the terminal (elimination) half-life of finasteride itself, as stated in the FDA label's Clinical Pharmacology section. Age: the label says mean terminal half-life rises to about 8 hours in men over 70, but no dosage adjustment is recommended. Kidney: in chronic renal impairment (creatinine clearance 9 to 55 mL/min) the label reports half-life, AUC, peak concentration and protein binding after a single dose were similar to healthy volunteers, with more of the metabolites leaving in the feces instead of the urine; no dosage adjustment is necessary. Liver: finasteride is extensively metabolized by CYP3A4, and this label gives no half-life data in hepatic impairment, so none is reported here. Metabolites: finasteride is not a prodrug, and its two identified metabolites have no more than 20% of finasteride's 5-alpha-reductase inhibitory activity, so there is no active metabolite that outlasts and substitutes for the parent. One important caveat: the drug's biological effect outlives the drug in the blood. The label notes the finasteride-enzyme complex turns over slowly (half-life roughly 30 days for the Type II enzyme complex and 14 days for Type I), so DHT suppression persists well after plasma finasteride has cleared. Plasma half-life is not a detection window and not dosing guidance.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: Finasteride tablet, film coated — DailyMed FDA label (SPL set id 00e934bb-c15b-490a-a852-839689a1231a), Section 12.3 Pharmacokinetics.
Drug class
May treat (source: NIH RxClass)
See how Proscar ranks — best-rated 5-alpha reductase inhibitor for:
Dosage forms
Tablet
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
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Frequently asked questions
- What does Proscar treat?
- Proscar (Finasteride) may be used to treat alopecia, hirsutism, prostatic hyperplasia, prostatic neoplasms, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How is Proscar rated?
- pharmaranks gives Proscar a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Proscar cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $2.07 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Proscar?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Proscar. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Proscar?
- Proscar is marketed by Organon. You can see Organon's full profile, rating, and other products on pharmaranks.
- Is Proscar a brand-name or generic drug?
- Proscar is a brand-name product with the active ingredient Finasteride. Lower-cost generic equivalents containing Finasteride are available — ask your pharmacist.
- Is Proscar available over the counter?
- No. Proscar is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Proscar come in?
- Proscar is currently marketed as tablet, per the FDA's National Drug Code Directory.
- What class of drug is Proscar?
- Proscar is classified as 5-alpha reductase inhibitor, per the FDA's Established Pharmacologic Class.
- Is Proscar FDA-registered?
- Proscar is on record with the U.S. FDA under application number NDA020180. You can verify this on its official FDA label.
- Has Proscar been recalled by the FDA?
- Proscar has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Proscar safe?
- There's no single safe-or-not verdict. pharmaranks gives Proscar a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Proscar?
- Proscar's side effects are taken directly from its FDA label. From the label: 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 ).… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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proscar
70/100