Prescription medicine
Silodosin First approved as Rapaflo
Silodosin (Rapaflo) is a prescription medicine with an FDA approval on record since 2008. FDA's NDC Directory lists it from 13 generic labelers, and pharmacies paid $0.319 per silodosin 8 mg capsule in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the silodosin FDA label on DailyMed (effective April 15, 2026, Amneal Pharmaceuticals NY LLC); the NDA 22206 record on Drugs@FDA; every silodosin label on DailyMed.
Highlights of the record
FDA label of April 15, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageSilodosin, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies (14 ) ].
Forms and strengths
- 4 mg
- 8 mg
Capsule.
On the market
- Earliest approval on file
- October 8, 2008 Rapaflo, Abbvie; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 13 first March 31, 2017; 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)
- $0.319 per capsule Silodosin 8 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2025 0 Class I among all firms' recalls; latest February 4, 2025
- FAERS reports
- 3,956 through July 30, 2026
What is silodosin used for?
From the label: indications and usageSilodosin, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies (14 ) ]. Silodosin capsules are not indicated for the treatment of hypertension. Silodosin, an alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). Silodosin capsules are not indicated for the treatment of hypertension.
Conditions named in the indications of silodosin's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: alpha-Adrenergic Blocker.
Source: FDA drug label (Silodosin), Amneal Pharmaceuticals NY LLC, effective April 15, 2026 (SPL set de619e27-9384-4b86-abdc-de0557cd39e8), via openFDA; the full label on DailyMed
Is there a generic for silodosin (Rapaflo)?
The FDA approved the first generic silodosin on March 31, 2017. 13 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 silodosin 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.
- 2008 earliest approval on file
- 2017 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 silodosin (Rapaflo)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.319 per Silodosin 8 mg capsule, down 29% from $0.451 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.
- Silodosin 8 mg capsule (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Silodosin 4 mg capsule | Generic | $0.265 per capsule | $7.95 | -25% |
| Silodosin 8 mg capsule | Generic | $0.319 per capsule | $9.56 | -29% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has silodosin been recalled?
The FDA's Enforcement Report lists 1 recall naming silodosin since 2025: 0 Class I (the most serious), 1 Class II, 0 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| February 4, 2025 | Class II | AvKARE | Subpotent Drug: Out of Specification (OOS) result for De hydro Impurity (0.654%) for 18 M Stability sample and low assay 94.9% (specification of NLT 95.0% NMT … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the silodosin label say about other medicines?
The silodosin label names 11 other medicines in its interaction, contraindication or warning sections. The labels of 2 other medicines name silodosin. 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 |
|---|---|---|
| Clarithromycin | contraindications | CONTRAINDICATIONS Severe renal impairment (CCr < 30 mL/min) Severe hepatic impairment (Child-Pugh score ≥ 10) Concomitant administration with strong Cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ketoconazole, clarithromycin, itraconazole, ritonavir) [see Drug Interactions (7.1) ] Patients with a history of … |
| Cyclosporine | drug interactions | DRUG INTERACTIONS Strong P-glycoprotein inhibitors (e.g., cyclosporine): Co-administration may increase plasma silodosin concentration. |
| Digoxin | drug interactions | Concomitant administration of silodosin and digoxin did not significantly alter the steady-state pharmacokinetics of digoxin. |
| Diltiazem | drug interactions | Concomitant administration with moderate CYP3A4 inhibitors (e.g., diltiazem, erythromycin, verapamil) may increase concentration of silodosin. |
| Erythromycin | drug interactions | Concomitant administration with moderate CYP3A4 inhibitors (e.g., diltiazem, erythromycin, verapamil) may increase concentration of silodosin. |
| Itraconazole | contraindications | CONTRAINDICATIONS Severe renal impairment (CCr < 30 mL/min) Severe hepatic impairment (Child-Pugh score ≥ 10) Concomitant administration with strong Cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ketoconazole, clarithromycin, itraconazole, ritonavir) [see Drug Interactions (7.1) ] Patients with a history of … |
| Ketoconazole | contraindications | CONTRAINDICATIONS Severe renal impairment (CCr < 30 mL/min) Severe hepatic impairment (Child-Pugh score ≥ 10) Concomitant administration with strong Cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ketoconazole, clarithromycin, itraconazole, ritonavir) [see Drug Interactions (7.1) ] Patients with a history of … |
| Ritonavir | contraindications | CONTRAINDICATIONS Severe renal impairment (CCr < 30 mL/min) Severe hepatic impairment (Child-Pugh score ≥ 10) Concomitant administration with strong Cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ketoconazole, clarithromycin, itraconazole, ritonavir) [see Drug Interactions (7.1) ] Patients with a history of … |
| Sildenafil | drug interactions | PDE5 Inhibitors Co-administration of silodosin with a single dose of 100 mg sildenafil or 20 mg tadalafil was evaluated in a placebo-controlled clinical study that included 24 healthy male subjects, 45 to 78 years of age. |
| Tadalafil | drug interactions | PDE5 Inhibitors Co-administration of silodosin with a single dose of 100 mg sildenafil or 20 mg tadalafil was evaluated in a placebo-controlled clinical study that included 24 healthy male subjects, 45 to 78 years of age. |
| Verapamil | drug interactions | Concomitant administration with moderate CYP3A4 inhibitors (e.g., diltiazem, erythromycin, verapamil) may increase concentration of silodosin. |
Source: FDA drug label (Silodosin), Amneal Pharmaceuticals NY LLC, effective April 15, 2026 (SPL set de619e27-9384-4b86-abdc-de0557cd39e8), via openFDA; the full label on DailyMed
What do FAERS reports show for silodosin?
The FDA Adverse Event Reporting System holds 3,956 reports that list silodosin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 499 are coded as a death and 1,960 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 silodosin?
6 other medicines are given the same way (oral) and in the same FDA class as silodosin 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 |
| Tamsulosin | Enlarged prostate (BPH) | 37 labelers | $0.05 per capsule 0.4 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 |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does silodosin compare with medicines for the same use?
6 side-by-side pages set silodosin beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to silodosin
- 6 medicines for the same use
- Other alpha blockers
- the pharmacologic class, with prices and generics
- Silodosin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other