Dutasteride
Dutasteride is a 5 alpha-reductase inhibitor used to treat symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate, alone or together with tamsulosin.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 25 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Dutasteride (Avodart) shrinks an enlarged prostate (BPH) by blocking the conversion of testosterone to DHT, the hormone behind prostate growth, easing symptoms and lowering the risk of sudden inability to urinate or surgery; it has been a familiar choice since about 2001, available generically and often paired with tamsulosin. Most men tolerate it well; what they notice is mostly sexual (lower sex drive, erection trouble, ejaculation changes) or breast tenderness. It roughly halves your PSA (a prostate cancer screening blood test), so tell whoever orders one, and have any confirmed rise checked even if it looks normal. Women who are or could become pregnant should not handle the capsules.
Clinical pearls
- Swallow the capsule whole and never chew or open it, since the contents can irritate your mouth and throat.
- Relief builds slowly over several months as the prostate shrinks, so do not judge it after a few weeks.
- Do not donate blood while taking it or for at least 6 months after your last dose.
- A pregnant woman who touches a leaking capsule should wash the skin right away with soap and water.
Patient information guide A plain-language walkthrough of Dutasteride, written from its FDA label.
What Dutasteride is used for
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Dutasteride is used for men with symptomatic BPH.
- Avodart (oral capsule) and dutasteride capsules, alone, to improve BPH symptoms in men with an enlarged prostate.
- Avodart and dutasteride capsules, alone, to reduce the risk of acute urinary retention.
- Avodart and dutasteride capsules, alone, to reduce the risk of BPH-related surgery.
- Avodart and dutasteride capsules together with tamsulosin for symptomatic BPH in men with an enlarged prostate.
- They are not approved to prevent prostate cancer.
How Dutasteride works
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Dutasteride blocks both type 1 and type 2 forms of the 5 alpha-reductase enzyme. This enzyme converts testosterone into DHT, the hormone mainly responsible for prostate growth. Dutasteride binds to the enzyme and releases from it extremely slowly. It does not bind to the human androgen receptor.
Dutasteride dosage
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Dutasteride is a capsule taken by mouth once daily, with or without food. Swallow it whole, since opening or chewing it can irritate the mouth and throat.
- Used alone, it is taken once daily.
- With tamsulosin, both medicines are taken once daily.
Follow your prescriber's directions and the label.
Dosing details from the FDA-approved label
From the Dutasteride prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Monotherapy
- 1 capsule (0.5 mg) taken once daily
- Swallow whole, do not chew or open; may be taken with or without food
- Combination with Alpha-adrenergic Antagonist
- 1 capsule (0.5 mg) taken once daily and tamsulosin 0.4 mg taken once daily
- Swallow whole, do not chew or open; may be taken with or without food
Read the label’s full dosing text
2 DOSAGE & ADMINISTRATION The capsules should be swallowed whole and not chewed or opened, as contact with the capsule contents may result in irritation of the oropharyngeal mucosa. Dutasteride Capsules may be administered with or without food. 2.1 Monotherapy The recommended dose of Dutasteride Capsules is 1 capsule (0.5 mg) taken once daily. 2.2 Combination With Alpha-adrenergic Antagonist The recommended dose of Dutasteride Capsules is 1 capsule (0.5 mg) taken once daily and tamsulosin 0.4 mg taken once daily. Monotherapy: 0.5 mg once daily. (2.1) Combination with tamsulosin: 0.5 mg once daily and tamsulosin 0.4 mg once daily. (2.2) Dosing considerations: Swallow whole. May take with or without food. (2)
Read the full Dosage and Administration section on DailyMed →
Dutasteride side effects
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The most common side effects are sexual and breast-related.
Common side effects
- Impotence (trouble getting or keeping an erection)
- Decreased sex drive (libido)
- Ejaculation problems
- Breast tenderness or enlargement
- Dizziness (when taken with tamsulosin)
- Ejaculation disorders
- Breast disorders, including tenderness and enlargement
- Dizziness, when combined with tamsulosin
When to get medical help
- Call your doctor if you develop signs of a serious allergic reaction, such as a serious skin reaction or swelling of the face, lips or throat (angioedema).
- Tell your doctor about any breast changes or concerns.
- Tell your doctor about any confirmed rise in PSA, since it may signal prostate cancer and needs evaluation.
- Contact your doctor if sexual side effects bother you or do not go away, since they may continue after stopping.
Ejaculation problems were more common with the combination (11%) than with dutasteride alone (2%). Sexual side effects may persist after stopping. Seek help for serious allergic reactions such as serious skin reactions or angioedema.
Dutasteride warnings and precautions
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- Prostate cancer: dutasteride may raise the risk of high-grade prostate cancer. In one 4-year trial, Gleason 8-10 cancers occurred in 1.0% of men on dutasteride versus 0.5% on placebo.
- PSA: it lowers PSA by about 50%. Doctors should set a new baseline after about 3 months. Any confirmed rise needs evaluation.
- Pregnancy exposure: it can be absorbed through the skin and may harm a male fetus.
- Blood donation: do not donate blood until 6 months after the last dose.
- Fertility: it may reduce sperm count, semen volume and motility. The clinical significance for fertility is not known.
Dutasteride interactions
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Few drug interactions were found, but some are worth knowing.
- Potent, long-term CYP3A4 inhibitors such as ritonavir: dutasteride is broken down by CYP3A4, so use caution.
- Verapamil and diltiazem: raise dutasteride exposure, but not significantly, and no dose change is needed.
- Tamsulosin and terazosin: dutasteride does not change their levels.
- Warfarin and digoxin: no change in how they behave in the body.
Interactions listed in the FDA-approved label
From the Dutasteride prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Potent, chronic CYP3A4 enzyme inhibitors (e.g., ritonavir): Dutasteride is extensively metabolized by CYP3A4 and CYP3A5, and the effect of potent CYP3A4 inhibitors on dutasteride has not been studied. Use caution when prescribing dutasteride to patients taking potent, chronic CYP3A4 enzyme inhibitors.
- Alpha-adrenergic antagonists (tamsulosin, terazosin): Dutasteride in combination with tamsulosin or terazosin has no effect on the steady-state pharmacokinetics of either alpha adrenergic antagonist; the effect of tamsulosin or terazosin on dutasteride pharmacokinetics has not been evaluated.
- Calcium channel antagonists (verapamil, diltiazem): Co-administration decreases dutasteride clearance and leads to increased exposure to dutasteride; the change is not considered to be clinically significant. No dose adjustment is recommended.
- Cholestyramine: A single 5-mg dose of dutasteride followed 1 hour later by 12 g of cholestyramine does not affect the relative bioavailability of dutasteride.
- Digoxin: Dutasteride does not alter the steady-state pharmacokinetics of digoxin when administered concomitantly at 0.5 mg/day for 3 weeks.
- Warfarin: Dutasteride 0.5 mg/day for 3 weeks with warfarin does not alter the steady-state pharmacokinetics of the S- or R-warfarin isomers or the effect of warfarin on prothrombin time.
Read the label’s full interactions text
7 DRUG INTERACTIONS 7.1 Cytochrome P450 3A Inhibitors: Dutasteride is extensively metabolized in humans by the cytochrome P450 (CYP)3A4 and CYP3A5 isoenzymes. The effect of potent CYP3A4 inhibitors on dutasteride has not been studied. Because of the potential for drug-drug interactions, use caution when prescribing Dutasteride to patients taking potent, chronic CYP3A4 enzyme inhibitors (e.g., ritonavir) [see Clinical Pharmacology (12.3)]. 7.2 Alpha-adrenergic Antagonists The administration of Dutasteride in combination with tamsulosin or terazosin has no effect on the steady-state pharmacokinetics of either alpha adrenergic antagonist. The effect of administration of tamsulosin or terazosin on Dutasteride pharmacokinetic parameters has not been evaluated. 7.3 Calcium Channel Antagonists Co administration of verapamil or diltiazem decreases dutasteride clearance and leads to increased exposure to Dutasteride. The change in Dutasteride exposure is not considered to be clinically significant. No dose adjustment is recommended [see Clinical Pharmacology (12.3)]. 7.4 Cholestyramine Administration of a single 5-mg dose of Dutasteride followed 1 hour later by 12 g of cholestyramine does not affect the relative bioavailability of dutasteride [see Clinical Pharmacology (12.3)]. 7.5 Digoxin Dutasteride does not alter the steady-state pharmacokinetics of digoxin when administered concomitantly at a dose of 0.5 mg/day for 3 weeks [see Clinical Pharmacology (12.3)]. 7.6 Warfarin Concomitant administration of Dutasteride 0.5 mg/day for 3 weeks with warfarin does not alter the steady-state pharmacokinetics of the S- or R-warfarin isomers or alter the effect of warfarin on prothrombin time [see Clinical Pharmacology (12.3)]. Use with caution in patients taking potent, chronic cytochrome P450 CYP3A4 enzyme inhibitors (e.g., ritonavir). (7) See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Revised 07/2024
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Dutasteride
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- Not for use in pregnancy or by women who could become pregnant.
- Not for children.
- Do not use if you had a serious allergic reaction to dutasteride or similar medicines.
- Tell your doctor about liver problems.
- No dose change is needed for kidney problems.
- Older adults showed no overall differences in safety or effectiveness.
- Your doctor should consider other urinary conditions with similar symptoms.
Dutasteride overdose
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In studies, much higher than usual doses were given without significant safety concerns. There is no specific antidote. If you suspect an overdose, treatment focuses on symptoms and supportive care, and the drug's long half-life is taken into account. Contact poison control or your doctor.
What Dutasteride does in the body
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Daily dutasteride lowers blood DHT in a dose-dependent way, with the maximum effect within 1 to 2 weeks. Median DHT fell by 85% after 1 week and 90% after 2 weeks. Over 4 years, DHT stayed about 93% to 95% lower. Testosterone rose modestly but stayed within the normal range.
How your body processes Dutasteride
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After a capsule, peak blood levels occur within 2 to 3 hours. Food lowers the peak by 10% to 15%, which is not clinically significant. Dutasteride is highly protein bound and is extensively broken down by the liver enzymes CYP3A4 and CYP3A5. It is eliminated mainly in feces, and some of the drug is found in semen.
How to store Dutasteride
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Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) .
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Dutasteride
138 supplements and herbal products have documented interactions with Dutasteride in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 3
- Moderate · 94
- Minor · 41
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Dutasteride: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Dutasteride — the kind of thing our pharmacy team would talk through with you at the counter.
What is dutasteride for?
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How do I take it?
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What side effects should I expect?
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Does it affect my PSA test?
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Can my partner or other women handle the capsules?
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Can I donate blood while taking it?
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Is Dutasteride available over the counter?
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When was Dutasteride first available?
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Who makes Dutasteride?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Dutasteride on HelloPharmacist
Dutasteride forms and strengths (how it comes)
Dutasteride is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Capsule
How this form is used
- Avodart is used by mouth for symptomatic BPH in men with an enlarged prostate, alone or with tamsulosin.
- Dutasteride capsules are used for symptomatic BPH in men with an enlarged prostate, alone or with tamsulosin.
- Avodart and dutasteride capsules are not approved to prevent prostate cancer.
- Avodart capsules should be swallowed whole, not chewed or opened.
- Avodart may be taken with or without food.
- Dutasteride capsules should be swallowed whole, not chewed or opened.
- Dutasteride capsules may be taken with or without food.
Dutasteride on the U.S. market: products, makers and brands
How Dutasteride appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
12 companies list 21 Dutasteride product records with the FDA, mostly as capsule; the earliest marketing or approval year on record is 2001. Brand names on the directory include Avodart; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (19) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Dutasteride is used (Medicaid data)
A general measure of how commonly Dutasteride is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Dutasteride is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Dutasteride prescribed? Of the 1,601 medications we measure, Dutasteride ranks #678 by Medicaid prescriptions — more than 58% of them.
Utilization by Dutasteride product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
dutasteride 0.5 MG Oral Capsule
Summed across the 7 of 74 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 351172
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Dutasteride, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 7 of 74 listed Dutasteride NDCs with Medicaid activity.
Compare Dutasteride products
A representative set of FDA-listed product records for Dutasteride — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Capsule | ||||
| 0.5 mg | Oral | A-S Medication Solutions × 3 listings | ANDA | View NDC → |
| 0.5 mg | Oral | Amneal Pharmaceuticals LLC | ANDA | View NDC → |
| 0.5 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 0.5 mg | Oral | Banyan Pharma LLC | ANDA | View NDC → |
| 0.5 mg | Oral | Bryant Ranch Prepack × 4 listings | ANDA | View NDC → |
| 0.5 mg | Oral | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| 0.5 mg | Oral | Epic Pharma, LLC | ANDA | View NDC → |
| 0.5 mg | Oral | Marksans Pharma Limited | ANDA | View NDC → |
| 0.5 mg | Oral | NuCare Pharmaceuticals, Inc. × 3 listings | ANDA | View NDC → |
| 0.5 mg | Oral | NuCare Pharmaceuticals,Inc. | ANDA | View NDC → |
| 0.5 mg | Oral | Proficient Rx LP × 2 listings | ANDA | View NDC → |
| 0.5 mg | Oral | Strides Pharma Science Limited | ANDA | View NDC → |
| 0.5 mg | Oral | XLCare Pharmaceuticals, Inc. | ANDA | View NDC → |
Showing 21 of 21 products — FDA National Drug Code Directory. See every product, package size and price: browse all 21 Dutasteride NDCs →
Dutasteride side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Dutasteride — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Dutasteride in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Dutasteride FDA approval history
How Dutasteride went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Dutasteride recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Dutasteride recalls since July 2021.
✅No Dutasteride recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 228790 1 dose form · 1 strength
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Dose form (SCDF) Oral Capsule RxCUI 378716In current FDA listingsClinical drug / strength (SCD) 0.5 MGRxCUI 351172
Look up RxCUI 228790 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Dutasteride supply and shortage status
Whether Dutasteride is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
💵 What Dutasteride costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Capsule · Oral | 0.5 mg | $0.157–$0.196 per capsule | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Dutasteride brand names
Dutasteride is sold under one brand name in the FDA directory — Avodart. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Dutasteride: manufacturers and labelers
12 companies list Dutasteride products with the FDA. By number of product records, the largest are Bryant Ranch Prepack, NuCare Pharmaceuticals, Inc., A-S Medication Solutions. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Dutasteride drug class (RxNorm)
Dutasteride belongs to the 5-alpha Reductase Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Dutasteride page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Waylis Therapeutics LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →