Prescription medicine
Dutasteride First approved as Avodart
Dutasteride (Avodart) is a prescription medicine with an FDA approval on record since 2001. FDA's NDC Directory lists it from 13 generic labelers, and pharmacies paid $0.157 per dutasteride 0.5 mg capsule in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the dutasteride FDA label on DailyMed (effective September 11, 2025, Aurobindo Pharma Limited); the NDA 21319 record on Drugs@FDA; every dutasteride label on DailyMed.
Highlights of the record
FDA label of September 11, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageDutasteride capsules are a 5 alpha-reductase inhibitor indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: ( 1.1 ) improve symptoms, reduce the risk of acute urinary retention, and reduce the risk of the need for BPH-related surgery.
Forms and strengths
- 0.5 mg
Liquid-filled capsule; capsule.
On the market
- Earliest approval on file
- November 20, 2001 Avodart, Waylis Therap; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 19 first December 21, 2010; 10 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 13 of which 13 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.157 per capsule Dutasteride 0.5 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 0 since 2013 0 Class I among all firms' recalls; 3 more by firms not listed as its makers
- FAERS reports
- 8,084 through July 30, 2026
What is dutasteride used for?
From the label: indications and usageDutasteride capsules are a 5 alpha-reductase inhibitor indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: ( 1.1 ) improve symptoms, reduce the risk of acute urinary retention, and reduce the risk of the need for BPH-related surgery. Dutasteride in combination with the alpha-adrenergic antagonist, tamsulosin, is indicated for the treatment of symptomatic BPH in men with an enlarged prostate. ( 1.2 ) Limitations of Use: Dutasteride capsules are not approved for the prevention of prostate cancer. […]
Conditions named in the indications of dutasteride's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: 5-alpha Reductase Inhibitor.
Source: FDA drug label (Dutasteride), Aurobindo Pharma Limited, effective September 11, 2025 (SPL set b32611f3-50ec-45bb-a671-ea10cec7829d), via openFDA; the full label on DailyMed
What does the patient leaflet for dutasteride say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What should I avoid while taking dutasteride capsules?You should not donate blood while taking dutasteride capsules or for 6 months after you have stopped dutasteride capsules. This is important to prevent pregnant women from receiving dutasteride through blood transfusions.
From the patient leaflet: How should I store dutasteride capsules?Store dutasteride capsules at room temperature (68°F to 77°F or 20°C to 25°C). Dutasteride capsules may become deformed and/or discolored if kept at high temperatures. Do not use dutasteride capsules if your capsules are deformed, discolored, or leaking. Safely throw away medicine that is no longer needed. Keep dutasteride capsules and all medicines out of the reach of children.
Source: FDA drug label (Dutasteride), Aurobindo Pharma Limited, effective September 11, 2025 (SPL set b32611f3-50ec-45bb-a671-ea10cec7829d), via openFDA; the full label on DailyMed
Is there a generic for dutasteride (Avodart)?
The FDA approved the first generic dutasteride on December 21, 2010. 19 generic applications are approved; 10 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists dutasteride from 13 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2001 earliest approval on file
- 2010 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for dutasteride (Avodart)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.157 per Dutasteride 0.5 mg capsule, down 12% from $0.179 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Dutasteride 0.5 mg capsule (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Dutasteride 0.5 mg capsule | Generic | $0.157 per capsule | $4.71 | -12% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has dutasteride been recalled?
The FDA's Enforcement Report lists 3 recalls naming dutasteride since 2013: 0 Class I (the most serious), 3 Class II, 0 Class III; 0 still ongoing. 3 of them are by firms that FDA's NDC Directory does not list as a maker of dutasteride and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| January 7, 2020 | Class II | AVKARE Inc. not a listed maker | Failed Impurities/Degradation Specifications: High out of specification results for related compounds. |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup: DUTASTERIDE, Capsule, 0.5 mg may have potentially been mislabeled as one of the following drugs: DOCUSATE SODIUM, Capsule, 250 mg, NDC … |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup: DUTASTERIDE, Capsule, 0.5 mg may have potentially been mislabeled as one of the following drugs: PHENOL, LOZENGE, 29 mg, NDC … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the dutasteride label say about other medicines?
The dutasteride label names 9 other medicines in its interaction, contraindication or warning sections. The labels of 2 other medicines name dutasteride. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Cholestyramine | drug interactions | 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)]. |
| Digoxin | drug interactions | 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) ]. |
| Diltiazem | drug interactions | Coadministration of verapamil or diltiazem decreases dutasteride clearance and leads to increased exposure to dutasteride. |
| Finasteride | warnings and precautions | In a 7-year placebo-controlled clinical trial with another 5 alpha-reductase inhibitor (finasteride 5 mg, PROSCAR ® ), similar results for Gleason score 8 to 10 prostate cancer were observed (finasteride 1.8% versus placebo 1.1%). |
| Ritonavir | drug interactions | DRUG INTERACTIONS Use with caution in patients taking potent, chronic cytochrome P450 (CYP)3A4 enzyme inhibitors (e.g., ritonavir). |
| Tamsulosin | drug interactions | The administration of dutasteride in combination with tamsulosin or terazosin has no effect on the steady-state pharmacokinetics of either alpha-adrenergic antagonist. |
| Terazosin | drug interactions | The administration of dutasteride in combination with tamsulosin or terazosin has no effect on the steady-state pharmacokinetics of either alpha-adrenergic antagonist. |
| Verapamil | drug interactions | Coadministration of verapamil or diltiazem decreases dutasteride clearance and leads to increased exposure to dutasteride. |
| Warfarin | drug interactions | 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) ]. |
Other labels that name dutasteride
Source: FDA drug label (Dutasteride), Aurobindo Pharma Limited, effective September 11, 2025 (SPL set b32611f3-50ec-45bb-a671-ea10cec7829d), via openFDA; the full label on DailyMed
What do FAERS reports show for dutasteride?
The FDA Adverse Event Reporting System holds 8,084 reports that list dutasteride among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,106 are coded as a death and 3,080 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as dutasteride?
6 other medicines are given the same way (oral) and in the same FDA class as dutasteride or labeled mainly for the same use (enlarged prostate (bph)), the same class first. Enlarged prostate (BPH) lists all 8 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Finasteride | Enlarged prostate (BPH) | 30 labelers | $0.0688 per tablet 5 mg tablet | No current entry |
| Doxazosin | Enlarged prostate (BPH) | 29 labelers | $0.0752 per tablet 1 mg tablet | No current entry |
| Terazosin | Enlarged prostate (BPH) | 21 labelers | $0.106 per capsule 2 mg capsule | No current entry |
| Tamsulosin | Enlarged prostate (BPH) | 37 labelers | $0.05 per capsule 0.4 mg capsule | No current entry |
| Silodosin | Enlarged prostate (BPH) | 13 labelers | $0.319 per capsule 8 mg capsule | No current entry |
| Alfuzosin | Enlarged prostate (BPH) | 10 labelers | $0.105 per tablet 10 mg tablet | No current entry |
Every medicine labeled for the same conditions as dutasteride
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does dutasteride compare with medicines for the same use?
5 side-by-side pages set dutasteride beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to dutasteride
- 6 medicines for the same use
- Other 5-alpha reductase inhibitors
- the pharmacologic class, with prices and generics
- Dutasteride side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other