Dosing & Uses
Dosage Forms & Strengths
tablet
- 1mg (Propecia)
- 5mg (Proscar)
Benign Prostatic Hyperplasia
Proscar: 5 mg PO qDay; assess response after 12 weeks to 6 months
Androgenic Alopecia (Men Only)
Propecia: 1 mg PO qDay for at least 3 months
Female Hirsutism (Off-label)
5 mg PO qDay
Dosage Modifications
Renal impairment: Dose adjustment not necessary
Hepatic impairment: Caution in liver dysfunction; monitor
Not indicated
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (0)
Monitor Closely (16)
- carbamazepine
carbamazepine will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- clarithromycin
clarithromycin will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- erythromycin base
erythromycin base will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- erythromycin ethylsuccinate
erythromycin ethylsuccinate will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- erythromycin lactobionate
erythromycin lactobionate will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- erythromycin stearate
erythromycin stearate will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- isoniazid
isoniazid will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- itraconazole
itraconazole will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- ketoconazole
ketoconazole will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- letermovir
letermovir increases levels of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- levoketoconazole
levoketoconazole will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- nefazodone
nefazodone will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- nevirapine
nevirapine will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- rifabutin
rifabutin will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- rifampin
rifampin will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- St John's Wort
St John's Wort will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
Minor (54)
- amobarbital
amobarbital will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- aprepitant
aprepitant will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- armodafinil
armodafinil will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- artemether/lumefantrine
artemether/lumefantrine will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- atazanavir
atazanavir will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- bosentan
bosentan will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- budesonide
budesonide will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- butabarbital
butabarbital will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- butalbital
butalbital will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- conivaptan
conivaptan will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- cortisone
cortisone will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- darifenacin
darifenacin will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- darunavir
darunavir will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- dasatinib
dasatinib will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- dexamethasone
dexamethasone will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- DHEA, herbal
DHEA, herbal will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- dronedarone
dronedarone will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- efavirenz
efavirenz will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- eslicarbazepine acetate
eslicarbazepine acetate will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- etravirine
etravirine will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- fluconazole
fluconazole will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- fludrocortisone
fludrocortisone will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- fosamprenavir
fosamprenavir will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- fosphenytoin
fosphenytoin will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- grapefruit
grapefruit will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- griseofulvin
griseofulvin will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- hydrocortisone
hydrocortisone will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- indinavir
indinavir will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- lapatinib
lapatinib will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- lumefantrine
lumefantrine will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- marijuana
marijuana will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- methylprednisolone
methylprednisolone will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- metronidazole
metronidazole will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- miconazole vaginal
miconazole vaginal will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- nelfinavir
nelfinavir will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- nifedipine
nifedipine will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- nilotinib
nilotinib will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- oxcarbazepine
oxcarbazepine will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- pentobarbital
pentobarbital will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- phenobarbital
phenobarbital will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- phenytoin
phenytoin will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- posaconazole
posaconazole will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- prednisone
prednisone will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- primidone
primidone will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- quinupristin/dalfopristin
quinupristin/dalfopristin will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- rifapentine
rifapentine will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- ritonavir
ritonavir will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- rufinamide
rufinamide will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- saw palmetto
saw palmetto increases effects of finasteride by pharmacodynamic synergism. Minor/Significance Unknown.
- secobarbital
secobarbital will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- topiramate
topiramate will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- verapamil
verapamil will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- voriconazole
voriconazole will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- zafirlukast
zafirlukast will increase the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
Adverse Effects
1-10%
Erectile dysfunction (1.3-8.1%)
Decrease libido (1.8-6.4%)
Breast enlargement (0.5-1.8%)
Ejaculation disorder (0.8-1.2%)
<1%
Breast tenderness (0.4-0.7%)
Rash (0.5%)
Postmarketing Reports
Neoplasms: Male breast cancer
Breast disorders: Breast tenderness and enlargement
Nervous system/psychiatric: Depression
Hypersensitivity reactions: 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, hematospermia, blood in semen
Warnings
Contraindications
Hypersensitivity
Women of childbearing potential
Cautions
Use with caution with obstructive uropathy; carefully monitor patients with large residual urinary volume or severely diminished urinary flow
Use caution in liver disease
May cause decreased serum PSA in presence of prostate cancer; increases in PSA levels from nadir while on finasteride may signal the presence of prostate cancer and should be carefully evaluated (even if PSA value within normal range)
Pregnant and potentially pregnant women should not handle crushed or broken tablets or semen of male partner; may have negative impact in fetal development
Rare reports of male breast cancer observed with use; any breast tenderness, enlargement, pain, lumps, nipple discharge or any other type of breast changes should be reported immediately to healthcare provider
5-ARIs and prostate cancer risk
- June 9, 2011: Recent data from 2 large, randomized, controlled trials observed a reduction in overall incidence of prostate cancer but an increased risk of being diagnosed with a more serious form of prostate cancer (high-grade prostate cancer) in trial participants taking 5-alpha reductase inhibitors (5-ARIs)
- The 2 trials are the Prostate Cancer Prevention Trial (PCPT) and the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial
- The revised prescribing information recommends that prior to initiating therapy with 5-ARIs, appropriate evaluation should be performed to rule out other urologic conditions, including prostate cancer, that might mimic benign prostatic hyperplasia (BPH)
- A minimum of 6 months may be necessary to assess response in BPH
Pregnancy & Lactation
Pregnancy
Therapy is contraindicated in pregnant females and not indicated for use in females; based on animal studies and mechanism of action, drug may cause abnormal development of external genitalia in a male fetus if administered to pregnant female
Animal data
- 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 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)
- Finasteride 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 potential hazard to 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 finasteride tablets or semen from a male partner taking finasteride
- With regard to finasteride exposure through skin, finasteride tablets are coated and will prevent skin contact with finasteride during normal handling if tablets have not been crushed or broken
- Females who are pregnant or may potentially be pregnant should not handle crushed or broken 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 5 mg/day finasteride; in these studies the highest amount of finasteride in semen was estimated to be 50-to 100-fold less than dose of finasteride (5 μg) that had no effect on circulating DHT levels in men
Reproductive potential
- Females: Drug not indicated for use in females
- Males: Treatment 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 normal range and were reversible upon discontinuation of therapy with average time to return to baseline of 84 weeks
- There have been postmarketing reports of male infertility and/or poor seminal quality; normalization or improvement of seminal quality has been reported after discontinuation of finasteride
Lactation
Drug is not indicated for use in females
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Selective inhibitor of type 1 & type 2 isoforms of 5-alpha-reductase; suppresses serum dihydrotestosterone levels by inhibiting the conversion of testosterone to dihydrotestosterone
Absorption
Bioavailability: 65%
Onset: 6 months (BPH); >3 months (hair loss)
Peak plasma time: 2-6 hours
Distribution
Protein bound: 90%
Vd: 76 L
Metabolism
Hepatic CYP3A4
Metabolites: t-butyl side chain monohydroxylate, monocarboxylic acid metabolite (active)
Elimination
Half-life: 6 hours
Excretion: Feces (57%); urine (39%)
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Propecia oral - | 1 mg tablet |  | |
| finasteride oral - | 1 mg tablet |  | |
| finasteride oral - | 5 mg tablet |  | |
| finasteride oral - | 5 mg tablet |  | |
| finasteride oral - | 5 mg tablet |  | |
| finasteride oral - | 5 mg tablet |  | |
| finasteride oral - | 5 mg tablet |  | |
| finasteride oral - | 5 mg tablet |  | |
| finasteride oral - | 5 mg tablet |  | |
| finasteride oral - | 1 mg tablet |  | |
| finasteride oral - | 1 mg tablet |  | |
| finasteride oral - | 5 mg tablet |  | |
| finasteride oral - | 1 mg tablet |  | |
| finasteride oral - | 1 mg tablet |  | |
| finasteride oral - | 1 mg tablet |  | |
| Proscar oral - | 5 mg tablet |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
finasteride oral
FINASTERIDE (HAIR GROWTH) - ORAL
(fin-AST-er-ide)
COMMON BRAND NAME(S): Propecia
USES: This medication is used to treat male pattern baldness (androgenetic alopecia) at the crown and in the middle of the scalp. It should be used by adult men only.This medication works by decreasing the amount of a natural body hormone (DHT). Decreasing the amount of DHT leads to increased hair regrowth and slower hair loss. Hair growth on other parts of the body is not affected by finasteride.Women and children should not use this medication.Finasteride is not approved for prevention of prostate cancer. It may slightly increase the risk of developing a very serious form of prostate cancer. Talk to your doctor about the benefits and risks.
HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking finasteride and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth with or without food as directed by your doctor, usually once a day.If the tablet is crushed or broken, it should not be handled by a woman who is pregnant or by a woman who may become pregnant (see also Precautions section).Use this medication regularly to get the most benefit from it. Remember to use it at the same time each day. It may take up to 3 months to notice a benefit.You must continue to take this medication to maintain your hair growth. When you stop taking finasteride, any gain in hair quantity is generally lost within 12 months.Tell your doctor if your condition does not improve or if it gets worse.
SIDE EFFECTS: Decreased sexual ability/desire may occur. In some men, this medication can decrease the amount of semen released during sex. This is harmless, but has continued in some men even after stopping treatment. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: lump in the breast, nipple discharge, breast enlargement/tenderness/pain, pain in the testicles, inability to urinate.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking finasteride, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, prostate cancer, infections, urinary problems.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).The drug can be absorbed through the skin. If the film coating of the tablet has been broken or the tablet crushed, it should not be handled by a woman who is pregnant or planning to become pregnant. Exposing a developing male infant to finasteride can result in abnormalities of the genitals.This medication should not be used in women, especially during pregnancy or breast-feeding. It may harm an unborn or breast-feeding baby. Consult your doctor if you have any questions about this medication.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.This medication can affect the results of the blood test used to detect prostate cancer (prostatic-specific antigen or PSA levels). If you have a PSA test done, make sure laboratory personnel and your doctors know you use this drug.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Do not share this drug with others.Follow your doctor's instructions for examining your breasts and testicles, and report any lumps right away.
MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised September 2021. Copyright(c) 2022 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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- View the formulary and any restrictions for each plan.
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