Avodart (Dutasteride): Brand Name, Generic, Cost & Uses

What Is Avodart?

Avodart is the original brand-name formulation of dutasteride, a dual 5-alpha-reductase inhibitor that blocks both Type 1 and Type 2 isoforms of the enzyme responsible for converting testosterone into dihydrotestosterone (DHT). GlaxoSmithKline (GSK) originally developed and marketed Avodart. FDA approved the first generic dutasteride products on November 20, 2015 (ANDA 202660, ANDA 203118 and ANDA 204705), after which multiple generic manufacturers entered the market.

The drug works by reducing serum DHT. Section 12.2 of the FDA label reports a median serum DHT decrease of 94% at 1 year in men taking 0.5 mg/day, against approximately 65% for finasteride at the 1 mg Propecia dose used for hair loss, and approximately 70% at the 5 mg Proscar dose used for BPH. Finasteride blocks only the Type 2 isoform. This mechanism underlies both its FDA-approved use in BPH and its off-label use for androgenetic alopecia (hair loss).

Avodart vs Generic Dutasteride: Is There a Difference?

Pharmacologically, Avodart and generic dutasteride are bioequivalent: they contain the same 0.5 mg dose of dutasteride in the same gelatin capsule formulation. The FDA requires generic manufacturers to demonstrate bioequivalence (same absorption rate and extent) before approval. In practice, patients switching between brand and generic dutasteride report no difference in efficacy or side effects.

Feature	Avodart (Brand)	Generic Dutasteride
Active ingredient	Dutasteride 0.5 mg	Dutasteride 0.5 mg
Originator and US application holder	Developed and launched by GlaxoSmithKline (GSK); NDA 021319 now held by Waylis Therapeutics LLC	Multiple ANDA holders, including Aurobindo, Amneal and Zydus
Relative cost	Higher	Lower
Insurance coverage (BPH)	Varies by plan formulary	Varies by plan formulary, usually on a lower tier than the brand
Available without insurance	Yes, with a prescription	Yes, with a prescription
Capsule color	Yellow oblong gelatin	Varies by manufacturer
Bioequivalent?	Reference product	Yes, demonstrated to FDA under the ANDA pathway

FDA Approval and Indications

The FDA approved Avodart (dutasteride) on November 20, 2001, under NDA 021319 for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate. The approved indication is to improve urinary symptoms and reduce the risk of acute urinary retention and the need for BPH-related surgery.

Dutasteride is also available in a fixed-dose combination with tamsulosin (an alpha-blocker) under the brand name Jalyn (dutasteride 0.5 mg + tamsulosin 0.4 mg), approved by the FDA in June 2010 under NDA 022460. Its label indicates it for the treatment of symptomatic BPH in men with an enlarged prostate.

Dutasteride (Avodart) is used off-label for androgenetic alopecia (male and female pattern hair loss) on the basis of its greater DHT suppression compared with finasteride. Dutasteride 0.5 mg/day is approved for androgenetic alopecia in South Korea (since 2009), Japan and Taiwan, but the US FDA has not approved it for that indication, so all US hair-loss use is off-label.

Avodart Dosage

The FDA-approved dose for BPH is 0.5 mg once daily, taken with or without food. The capsule should be swallowed whole. Dutasteride is absorbed through skin and mucous membranes, so broken or leaking capsules can expose people who handle them (including women of childbearing age, for whom dutasteride is contraindicated due to teratogenicity risk).

For off-label hair loss use, the same 0.5 mg once-daily dose is typically prescribed, though some clinicians use lower doses (0.1 mg, or 0.5 mg two to three times per week) to reduce systemic exposure. See our full dutasteride dosage guide for protocol details.

Avodart Side Effects

The side effect profile of Avodart is identical to generic dutasteride. The figures below come from the three pooled placebo-controlled BPH trials in the FDA label, and cover the first 6 months of treatment:

• Sexual side effects: impotence in 4.7% of men on dutasteride vs 1.7% on placebo, decreased libido in 3.0% vs 1.4%, and ejaculation disorders in 1.4% vs 0.5%. The label reports that the incidence of these reactions decreased with increased duration of treatment.
• Breast effects: breast disorders, including breast enlargement and tenderness, in 0.5% of men on dutasteride vs 0.2% on placebo in the first 6 months.
• PSA reduction: dutasteride reduces serum PSA by approximately 50% within 3 to 6 months. A new PSA baseline should be established at least 3 months after starting treatment, and any confirmed increase from the lowest PSA value while on dutasteride may signal prostate cancer and should be evaluated.
• Risk in pregnancy: the FDA label contraindicates dutasteride in pregnancy and in women of childbearing potential (section 4), because a 5α-reductase inhibitor can cause abnormalities of the external genitalia of a male fetus. The older letter-based pregnancy categories were removed from US labeling by the 2015 Pregnancy and Lactation Labeling Rule, so the current label carries the contraindication rather than a category letter. Women who are pregnant or may become pregnant must not handle leaking capsules. Men taking dutasteride should not donate blood until at least 6 months after their last dose.

For a complete side effects breakdown with incidence data, see our dutasteride side effects page.

Avodart Cost: Brand vs Generic

Since the first generics were approved in November 2015, brand Avodart has been largely displaced by generic dutasteride in cost-conscious prescribing. Formulary placement varies by plan, but generics generally sit on a lower tier than the brand, which means a lower copay. Cash-pay patients can compare pharmacy prices through a discount program such as GoodRx. Prices vary widely between pharmacies and change often, so check the current price at your own pharmacy rather than relying on a published figure.

Online telehealth platforms also prescribe dutasteride, and are an option for patients without insurance. See our dutasteride cost guide and online prescription options.

Avodart for Hair Loss

While Avodart and generic dutasteride are not FDA-approved for hair loss in the United States, they are widely used off-label for this purpose. In a 2025 Phase II trial (Panuganti VK et al., Cureus 2025;17(8):e89309), topical dutasteride at 0.01%, 0.02% and 0.05% produced dose-dependent increases in target area hair count over 24 weeks, and the investigators reported no significant change in serum testosterone or DHT in any dutasteride group. Several randomized trials have favored dutasteride over finasteride for androgenetic alopecia: the IJDVL study (Shanshanwal and Dhurat, 2017) found a significantly greater increase in total hair count with dutasteride 0.5 mg/day than with finasteride 1 mg/day at 24 weeks. A 2014 network meta-analysis of 5α-reductase inhibitors, by contrast, found no statistically significant efficacy difference between the active treatments, so the evidence is not unanimous.

See our detailed comparison: dutasteride vs finasteride for hair loss and our dutasteride for hair loss guide.

Frequently Asked Questions About Avodart

Is Avodart the same as dutasteride?
Yes. Avodart is the brand name for dutasteride. The active ingredient, dose (0.5 mg), and mechanism of action are identical. Generic dutasteride is bioequivalent and significantly cheaper.

Can I switch from Avodart to generic dutasteride?
Yes. The FDA requires generics to demonstrate bioequivalence to the brand. Switching is safe and routinely done; consult your prescriber before changing medications.

Is Avodart still manufactured?
Yes. Avodart was developed and launched by GlaxoSmithKline (GSK), and it remains an active prescription product in Drugs@FDA, with the US application (NDA 021319) now held by Waylis Therapeutics LLC. Generic dutasteride has been available in the US since November 2015.

Is Avodart available over the counter?
No. Dutasteride (Avodart) is a prescription-only medicine in the United States and in other major markets. See online dutasteride prescription options.

What is Jalyn?
Jalyn is a combination product containing dutasteride 0.5 mg and tamsulosin 0.4 mg in a single capsule, approved for BPH. It combines the DHT-reducing effect of dutasteride with the alpha-blocking effect of tamsulosin to address both hormonal and mechanical components of BPH. See our dutasteride + tamsulosin combination guide.

Sources and References

• FDA Prescribing Information: Dutasteride (Avodart), NDA 021319
• StatPearls: Dutasteride, NCBI Bookshelf
• MedlinePlus: Dutasteride
• FDA Prescribing Information: Jalyn (dutasteride and tamsulosin hydrochloride)
• FDA Prescribing Information: Proscar (finasteride)
• Choi GS, et al. Long-Term Effectiveness and Safety of Dutasteride versus Finasteride in Patients with Male Androgenic Alopecia in South Korea: A Multicentre Chart Review Study. Ann Dermatol. 2022;34(5):349-359. PubMed
• Panuganti VK, et al. A Randomized, Double-Blind, Placebo and Active Controlled Phase II Study to Evaluate the Safety and Efficacy of Novel Dutasteride Topical Solution (0.01%, 0.02%, and 0.05% w/v) in Male Subjects With Androgenetic Alopecia. Cureus. 2025;17(8):e89309. PMC12405733