propecia
Pharmaranks rates Propecia 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Propecia (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 1MG
- 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
- NDA020788
What is Propecia?
From the FDA label:PROPECIA (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. PROPECIA (finasteride) tablets 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, hydroxypropyl methylcellulose, hydroxypropyl cellulose, titanium dioxide, magnesium stearate, talc, docusate sodium, yellow ferric oxide, and red ferric oxide. image of finasteride chemical structure
How to use
PROPECIA may be administered with or without meals. The recommended dose of PROPECIA 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. PROPECIA 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 ).
Side effects
The most common adverse reactions, reported in ≥1% of patients treated with PROPECIA and greater than in patients treated with placebo are: decreased libido, erectile dysfunction and ejaculation disorder ( 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. Clinical Studies for PROPECIA (finasteride 1 mg) in the Treatment of Male Pattern Hair Loss In three controlled clinical trials for PROPECIA of 12-month duration, 1.4% of patients taking PROPECIA (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 PROPECIA or placebo are presented in Table 1 . TABLE 1: Drug-Related Adverse Experiences for PROPECIA (finasteride 1 mg) in Year 1 (%) MALE PATTERN HAIR LOSS PROPECIA N=945 Placebo N=934 Decreased Libido 1.8 1.3 Erectile Dysfunction 1.3 0.7…
Warnings
Important safety information
PROPECIA is not indicated for use in women or pediatric patients ( 5.1 , 5.4 ). Women should not handle crushed or broken PROPECIA tablets when they are pregnant or may potentially be pregnant due to potential risk to a male fetus ( 5.1 , 8.1 , 16 ). PROPECIA causes a decrease in serum PSA levels. Any confirmed increase in PSA while on PROPECIA 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 ( 5.2 ). 5α-reductase inhibitors may increase the risk of high-grade prostate cancer ( 5.3 , 6.1 ). 5.1 Exposure of Women — Risk to Male Fetus PROPECIA is not indicated for use in women. Women should not handle crushed or broken PROPECIA 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. PROPECIA tablets are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets have not been broken or crushed. [See Indications and Usage (1) , Contraindications (4) , Use in Specific Populations (8.1) , How Supplied/Storage and Handling (16) and Patient Counseling Information (17) .] 5.2 Effects on Prostate Specific Antigen (PSA) In clinical studies with PROPECIA (finasteride, 1 mg) in men 18-41 years of age, the mean value of serum prostate specific antigen (PSA) decreased from 0.7 ng/mL at baseline to 0.5 ng/mL at Month 12. Further, in clinical studies with PROSCAR (finasteride, 5 mg) when used in older men who have benign prostatic hyperplasia (BPH), PSA levels are decreased by approximately 50%. Other studies with PROSCAR showed it may also cause decreases in serum PSA in the presence of prostate cancer. These findings should be taken into account for proper interpretation of serum PSA when evaluating men treated with finasteride. Any confirmed increase from the lowest PSA value while on PROPECIA 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 to therapy with PROPECIA may also affect PSA test results. 5.3 Increased Risk of High-Grade Prostate Cancer with 5α-Reductase Inhibitors Men aged 55 and over with a normal digital rectal examination and PSA ≤3.0 ng/mL at baseline taking finasteride 5 mg/day (5 times the dose of PROPECIA) 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 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. 5.4 Pediatric Patients PROPECIA is not indicated for use in pediatric patients [see Use in Specific Populations (8.4) ] .
Who should not take Propecia
PROPECIA is contraindicated in the following: Pregnancy. Finasteride use is contraindicated in women 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 woman who receives finasteride. If this drug is used during pregnancy, or if pregnancy occurs while taking this drug, the pregnant woman should be apprised of the potential hazard to the male fetus. [See Warnings and Precautions (5.1) , Use in Specific Populations (8.1) , How Supplied/Storage and Handling (16) and Patient Counseling Information (17) .] In female rats, low doses of finasteride administered during pregnancy have produced abnormalities of the external genitalia in male offspring. Hypersensitivity to any component of this medication. Pregnancy ( 4 , 5.1 , 8.1 , 16 ). Hypersensitivity to any components of this product ( 4 ).
Overdose — what happens if you take too much
In clinical studies, single doses of finasteride up to 400 mg and multiple doses of finasteride up to 80 mg/day for three months did not result in adverse reactions. Until further experience is obtained, no specific treatment for an overdose with finasteride 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 include 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, finasteride doses of 1 mg or more were concomitantly used in clinical studies with acetaminophen, acetylsalicylic acid, α-blockers, analgesics, angiotensin-converting enzyme (ACE) inhibitors, anticonvulsants, benzodiazepines, beta blockers, calcium-channel blockers, cardiac nitrates, diuretics, H 2 antagonists, HMG-CoA reductase inhibitors, prostaglandin synthetase inhibitors (also referred to as NSAIDs), 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 Propecia 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 Propecia treat?
- Propecia (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 Propecia rated?
- pharmaranks gives Propecia 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 Propecia 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 Propecia?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Propecia. 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 Propecia?
- Propecia is marketed by Organon. You can see Organon's full profile, rating, and other products on pharmaranks.
- Is Propecia a brand-name or generic drug?
- Propecia is a brand-name product with the active ingredient Finasteride. Lower-cost generic equivalents containing Finasteride are available — ask your pharmacist.
- Is Propecia available over the counter?
- No. Propecia 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 Propecia come in?
- Propecia is currently marketed as tablet, per the FDA's National Drug Code Directory.
- What class of drug is Propecia?
- Propecia is classified as 5-alpha reductase inhibitor, per the FDA's Established Pharmacologic Class.
- Is Propecia FDA-registered?
- Propecia is on record with the U.S. FDA under application number NDA020788. You can verify this on its official FDA label.
- Has Propecia been recalled by the FDA?
- Propecia 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 Propecia safe?
- There's no single safe-or-not verdict. pharmaranks gives Propecia 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 Propecia?
- Propecia's side effects are taken directly from its FDA label. From the label: The most common adverse reactions, reported in ≥1% of patients treated with PROPECIA and greater than in patients treated with placebo are: decreased libido, erectile dysfunction and ejaculation disorder ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Organon LLC,… 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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propecia
70/100