Prescription medicine
Tamsulosin First approved as Flomax
Tamsulosin (Flomax) is a prescription medicine with an FDA approval on record since 1997. FDA's NDC Directory lists it from 38 generic labelers, and pharmacies paid $0.05 per tamsulosin HCl 0.4 mg capsule in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the tamsulosin FDA label on DailyMed (effective December 1, 2025, Synthon Pharmaceuticals, Inc.); the NDA 20579 record on Drugs@FDA; every tamsulosin label on DailyMed.
Highlights of the record
FDA label of December 1, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageTamsulosin hydrochloride capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies (14) ].
Forms and strengths
- 0.4 mg
Capsule.
On the market
- Earliest approval on file
- April 15, 1997 Flomax, Sanofi; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 15 first March 2, 2010; 11 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 38 of which 38 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.05 per capsule Tamsulosin HCl 0.4 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 3 since 2015 0 Class I among all firms' recalls; latest July 17, 2019
- FAERS reports
- 20,287 through July 30, 2026
What is tamsulosin used for?
From the label: indications and usageTamsulosin hydrochloride capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies (14) ]. Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension. Tamsulosin hydrochloride capsules are an alpha 1 adrenoceptor antagonist indicated for treatment of the signs and symptoms of benign prostatic hyperplasia ( 1 ) Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension
Conditions named in the indications of tamsulosin's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: alpha-Adrenergic Blocker.
Source: FDA drug label (Tamsulosin hydrochloride), Synthon Pharmaceuticals, Inc., effective December 1, 2025 (SPL set 13a5032d-0be1-4001-916e-459f0b1a051d), via openFDA; the full label on DailyMed
What does the patient leaflet for 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 tamsulosin hydrochloride capsules?Avoid driving, operating machinery, or other dangerous activities, until you know how tamsulosin hydrochloride capsules affects you. Tamsulosin hydrochloride capsules may cause a sudden drop in blood pressure upon standing, especially after the first dose or when changing doses. See " What are the possible side effects of tamsulosin hydrochloride capsules? " How do I store tamsulosin hydrochloride capsules? Store tamsulosin hydrochloride capsules at Room Temperature 68°F to 77°F (20°C to 25°C). Short-term exposure to higher or lower temperatures (from 59°F [15°C] to 86°F [30°C]) is acceptable. Ask your doctor or pharmacist if you have any questions about storing your capsules. Keep tamsulosin hydrochloride capsules and all medicines out of the reach of children. General information This medicine was prescribed for you by your doctor for your condition. Do not use it for another condition. […]
Source: FDA drug label (Tamsulosin hydrochloride), Synthon Pharmaceuticals, Inc., effective December 1, 2025 (SPL set 13a5032d-0be1-4001-916e-459f0b1a051d), via openFDA; the full label on DailyMed
Is there a generic for tamsulosin (Flomax)?
The FDA approved the first generic tamsulosin on March 2, 2010. 15 generic applications are approved; 11 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 tamsulosin from 38 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.
- 1997 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 tamsulosin (Flomax)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.05 per Tamsulosin HCl 0.4 mg capsule, down 2% from $0.0512 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.
- Tamsulosin HCl 0.4 mg capsule (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Tamsulosin HCl 0.4 mg capsule | Generic | $0.05 per capsule | $1.50 | -2% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has tamsulosin been recalled?
The FDA's Enforcement Report lists 3 recalls naming tamsulosin since 2015: 0 Class I (the most serious), 3 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 17, 2019 | Class II | Macleods Pharma Usa Inc | Failed Dissolution Specifications |
| February 22, 2019 | Class II | Ascend Laboratories LLC | Failed Dissolution Specifications: High Out-of-Specification dissolution results were observed during stability testing. |
| April 22, 2015 | Class II | Wockhardt Usa Inc. | CGMP Deviations: Firm did not adequately investigate customer complaints. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the tamsulosin label say about other medicines?
The tamsulosin label names 12 other medicines in its interaction, contraindication or warning sections. The labels of 6 other medicines name tamsulosin. 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 hydrochloride capsules are administered concomitantly with nifedipine, atenolol, or enalapril [see Clinical Pharmacology (12.3) ]. |
| Cimetidine | drug interactions | Cimetidine Treatment with cimetidine resulted in a significant decrease (26%) in the clearance of tamsulosin hydrochloride, which resulted in a moderate increase in tamsulosin hydrochloride AUC (44%) [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.3) ]. |
| Digoxin | drug interactions | Dosage adjustments are not necessary when a tamsulosin hydrochloride capsule is administered concomitantly with digoxin or theophylline [see Clinical Pharmacology (12.3) ]. |
| Enalapril | drug interactions | Dosage adjustments are not necessary when tamsulosin hydrochloride capsules are administered concomitantly with nifedipine, atenolol, or enalapril [see Clinical Pharmacology (12.3) ]. |
| Erythromycin | drug interactions | Tamsulosin hydrochloride capsules should be used with caution in combination with moderate inhibitors of CYP3A4 (e.g., erythromycin), in combination with strong (e.g., paroxetine) or moderate (e.g., terbinafine) inhibitors of CYP2D6, or in patients known to be CYP2D6 poor metabolizers, particularly at a dose higher … |
| 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 tamsulosin hydrochloride capsules dosage [see Clinical Pharmacology (12.3) ]. |
| Ketoconazole | drug interactions | DRUG INTERACTIONS Tamsulosin hydrochloride capsules 0.4 mg should not be used with strong inhibitors of CYP3A4 (e.g., ketoconazole). |
| Nifedipine | drug interactions | Dosage adjustments are not necessary when tamsulosin hydrochloride capsules are administered concomitantly with nifedipine, atenolol, or enalapril [see Clinical Pharmacology (12.3) ]. |
| Paroxetine | drug interactions | Tamsulosin hydrochloride capsules should be used with caution in combination with moderate inhibitors of CYP3A4 (e.g., erythromycin), in combination with strong (e.g., paroxetine) or moderate (e.g., terbinafine) inhibitors of CYP2D6, or in patients known to be CYP2D6 poor metabolizers, particularly at a dose higher … |
| Terbinafine | drug interactions | Tamsulosin hydrochloride capsules should be used with caution in combination with moderate inhibitors of CYP3A4 (e.g., erythromycin), in combination with strong (e.g., paroxetine) or moderate (e.g., terbinafine) inhibitors of CYP2D6, or in patients known to be CYP2D6 poor metabolizers, particularly at a dose higher … |
| Theophylline | drug interactions | Dosage adjustments are not necessary when a tamsulosin hydrochloride capsule is administered concomitantly with digoxin or theophylline [see Clinical Pharmacology (12.3) ]. |
| Warfarin | drug interactions | Caution should be exercised with concomitant administration of warfarin and tamsulosin hydrochloride capsules [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.3) ]. |
Other labels that name tamsulosin
Source: FDA drug label (Tamsulosin hydrochloride), Synthon Pharmaceuticals, Inc., effective December 1, 2025 (SPL set 13a5032d-0be1-4001-916e-459f0b1a051d), via openFDA; the full label on DailyMed
What do FAERS reports show for tamsulosin?
The FDA Adverse Event Reporting System holds 20,287 reports that list tamsulosin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2,204 are coded as a death and 7,120 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 tamsulosin?
6 other medicines are given the same way (oral) and in the same FDA class as tamsulosin 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 |
|---|---|---|---|---|
| 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 |
| 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 |
| Finasteride | Enlarged prostate (BPH) | 30 labelers | $0.0688 per tablet 5 mg tablet | No current entry |
| Dutasteride | Enlarged prostate (BPH) | 13 labelers | $0.157 per capsule 0.5 mg capsule | No current entry |
Every medicine labeled for the same conditions as tamsulosin
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does tamsulosin compare with medicines for the same use?
7 side-by-side pages set tamsulosin beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to tamsulosin
- 6 medicines for the same use
- Other alpha blockers
- the pharmacologic class, with prices and generics
- Tamsulosin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other