Prescription medicine
Dutasteride and tamsulosin Brand names: Jalyn
Dutasteride and tamsulosin (Jalyn) is a prescription medicine with an FDA approval on record since 2010. FDA's NDC Directory lists it from 3 generic labelers, and pharmacies paid $1.97 per unit (Dutasteride-tamsulosin 0.5-0.4) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the dutasteride and tamsulosin FDA label on DailyMed (effective March 9, 2026, Waylis Therapeutics); the NDA 22460 record on Drugs@FDA; every dutasteride and tamsulosin label on DailyMed.
Highlights of the record
FDA label of March 9, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageJALYN is a combination of dutasteride, a 5-alpha-reductase inhibitor, and tamsulosin, an alpha-adrenergic antagonist, indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate.
Forms and strengths
- 0.5 mg / 0.4 mg
Capsule.
On the market
- Earliest approval on file
- June 14, 2010 Jalyn, Waylis Therap; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 4 first February 26, 2014; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 4 of which 3 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $1.97 per unit Dutasteride-tamsulosin 0.5-0.4
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2017 0 Class I among all firms' recalls; latest October 25, 2017
- FAERS reports
- 1,044 through July 30, 2026
What is dutasteride and tamsulosin used for?
From the label: indications and usageJALYN is a combination of dutasteride, a 5-alpha-reductase inhibitor, and tamsulosin, an alpha-adrenergic antagonist, indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate. ( 1.1 ) Limitations of Use: Dutasteride-containing products, including JALYN, are not approved for the prevention of prostate cancer. ( 1.2 ) 1.1 Benign Prostatic Hyperplasia (BPH) Treatment JALYN (dutasteride and tamsulosin hydrochloride) capsules are indicated for the treatment of symptomatic BPH in men with an enlarged prostate. 1.2 Limitations of Use Dutasteride-containing products, including JALYN, are not approved for the prevention of prostate cancer.
FDA pharmacologic class: 5-alpha Reductase Inhibitor and alpha-Adrenergic Blocker.
Source: FDA drug label (Jalyn), Waylis Therapeutics, effective March 9, 2026 (SPL set aab9a2d4-5328-40f3-986f-e7753a928bc0), via openFDA; the full label on DailyMed
What does the patient leaflet for dutasteride and tamsulosin 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 JALYN?Avoid driving, operating machinery, or other dangerous activities when starting treatment with JALYN until you know how JALYN affects you. JALYN can cause a sudden drop in your blood pressure, especially at the start of treatment. A sudden drop in blood pressure may cause you to faint, feel dizzy or lightheaded. You should not donate blood while taking JALYN or for 6 months after you have stopped JALYN. This is important to prevent pregnant females from receiving JALYN through blood transfusions.
From the patient leaflet: How should I store JALYN?Store JALYN capsules at room temperature (59° to 86°F or 15° to 30°C). JALYN capsules may become deformed and/or discolored if kept at high temperatures. Do not use or touch JALYN if your capsules are deformed, discolored, or leaking. Safety throw away medicines that is no longer needed. Keep JALYN and all medicines out of the reach of children.
Source: FDA drug label (Jalyn), Waylis Therapeutics, effective March 9, 2026 (SPL set aab9a2d4-5328-40f3-986f-e7753a928bc0), via openFDA; the full label on DailyMed
Is there a generic for dutasteride and tamsulosin (Jalyn)?
The FDA approved the first generic dutasteride and tamsulosin on February 26, 2014. 4 generic applications are approved; 2 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 and tamsulosin from 3 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2010 earliest approval on file
- 2014 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 and tamsulosin (Jalyn)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $1.97 per unit (Dutasteride-tamsulosin 0.5-0.4), down 14% from $2.29 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-tamsulosin 0.5-0.4 (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Dutasteride-tamsulosin 0.5-0.4 | Generic | $1.97 per unit | n/a | -14% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has dutasteride and tamsulosin been recalled?
The FDA's Enforcement Report lists 1 recall naming dutasteride and tamsulosin since 2017: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| October 25, 2017 | Class II | Teva Pharmaceuticals USA | Failed dissolution specifications; all lots within expiry are being recalled due to out of specification dissolution results. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the dutasteride and tamsulosin label say about other medicines?
The dutasteride and tamsulosin label names 16 other medicines in its interaction, contraindication or warning sections. 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 |
|---|---|---|
| Atenolol | drug interactions | Dosage adjustments are not necessary when tamsulosin is administered concomitantly with nifedipine, atenolol, or enalapril [see Clinical Pharmacology (12.3) ]. |
| Cholestyramine | drug interactions | Administration of a single 5-mg dose of dutasteride followed 1 hour later by a 12-g dose of cholestyramine does not affect the relative bioavailability of dutasteride [see Clinical Pharmacology (12.3) ]. |
| Cimetidine | drug interactions | Treatment with cimetidine resulted in a moderate increase in tamsulosin hydrochloride AUC (44%) [see Warnings and Precautions (5.2), Clinical Pharmacology (12.3) ]. |
| Digoxin | drug interactions | Tamsulosin Dosage adjustments are not necessary when tamsulosin is administered concomitantly with digoxin or theophylline [see Clinical Pharmacology (12.3) ]. |
| Diltiazem | drug interactions | Coadministration of verapamil or diltiazem decreases dutasteride clearance and leads to increased exposure to dutasteride. |
| Enalapril | drug interactions | Dosage adjustments are not necessary when tamsulosin is administered concomitantly with nifedipine, atenolol, or enalapril [see Clinical Pharmacology (12.3) ]. |
| Erythromycin | warnings and precautions | Use caution in combination with moderate CYP3A4 inhibitors (e.g., erythromycin) or strong (e.g., paroxetine) or moderate CYP2D6 inhibitors, a combination of both CYP3A4 and CYP2D6 inhibitors, or known poor metabolizers of CYP2D6. |
| Furosemide | drug interactions | While furosemide produced an 11% to 12% reduction in tamsulosin hydrochloride C max and AUC, these changes are expected to be clinically insignificant and do not require adjustment of the dose of tamsulosin [see Clinical Pharmacology (12.3) ]. |
| Ketoconazole | drug interactions | Concomitant treatment with ketoconazole (a strong inhibitor of CYP3A4) resulted in increases in the C max and area under the concentration-time curve (AUC) of tamsulosin by factors of 2.2 and 2.8, respectively. |
| Nifedipine | drug interactions | Dosage adjustments are not necessary when tamsulosin is administered concomitantly with nifedipine, atenolol, or enalapril [see Clinical Pharmacology (12.3) ]. |
| Paroxetine | drug interactions | Concomitant treatment with paroxetine (a strong inhibitor of CYP2D6) resulted in increases in the C max and AUC of tamsulosin by factors of 1.3 and 1.6, respectively. |
| Ritonavir | drug interactions | Because of the potential for drug-drug interactions, use caution when prescribing a dutasteride-containing product, including JALYN, to patients taking potent, chronic CYP3A4 enzyme inhibitors (e.g., ritonavir) [see Clinical Pharmacology (12.3) ] Tamsulosin Strong and Moderate Inhibitors of CYP3A4 or CYP2D6 … |
| Terbinafine | warnings and precautions | … coadministered with moderate inhibitors of CYP3A4 (e.g., erythromycin), strong (e.g., paroxetine) or moderate (e.g., terbinafine) inhibitors of CYP2D6, a combination of both CYP3A4 and CYP2D6 inhibitors, or in patients known to be poor metabolizers of CYP2D6, as there is a potential for significant increase in … |
| Theophylline | drug interactions | Tamsulosin Dosage adjustments are not necessary when tamsulosin is administered concomitantly with digoxin or theophylline [see Clinical Pharmacology (12.3) ]. |
Every other medicine the dutasteride and tamsulosin label names
| Medicine named | Section | What the label says |
|---|---|---|
| Verapamil | drug interactions | Coadministration of verapamil or diltiazem decreases dutasteride clearance and leads to increased exposure to dutasteride. |
| Warfarin | drug interactions | Caution should be exercised with concomitant administration of warfarin and tamsulosin-containing products, including JALYN [see Warnings and Precautions (5.2), Clinical Pharmacology (12.3) ]. |
Source: FDA drug label (Jalyn), Waylis Therapeutics, effective March 9, 2026 (SPL set aab9a2d4-5328-40f3-986f-e7753a928bc0), via openFDA; the full label on DailyMed
What do FAERS reports show for dutasteride and tamsulosin?
The FDA Adverse Event Reporting System holds 1,044 reports that list dutasteride and tamsulosin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 58 are coded as a death and 190 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 next?
- Other 5-alpha reductase inhibitors
- the pharmacologic class, with prices and generics
- Dutasteride and tamsulosin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other