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Silodosin

Silodosin is an alpha-blocker (alpha-1 adrenergic receptor antagonist) taken by mouth as a capsule to treat the signs and symptoms of benign prostatic hyperplasia (BPH), or enlarged prostate.

Brand name Rapaflo
Drug class Alpha-adrenergic Blocker
Rx Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 17 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 5, 2026 🚨Recall on record
Silodosin at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Silodosin (Rapaflo) is an alpha-blocker for the urinary symptoms of an enlarged prostate (benign prostatic hyperplasia, or BPH), relaxing muscle in the prostate and bladder neck so urine flows more easily; it is a common first choice, on the market since about 2006 and available generically. Most men tolerate it well, though it causes retrograde ejaculation (semen going backward into the bladder, so little or none comes out) more often than similar drugs; it is harmless and reverses after stopping. The thing to watch for is dizziness or fainting when you stand up, especially in the first days, so take it with a meal and get up slowly.

Clinical pearls

  • Never take it with clarithromycin, ketoconazole, itraconazole or ritonavir, which block its breakdown and push silodosin levels too high.
  • Before cataract surgery, tell your eye surgeon you take silodosin, since it can cause a floppy iris problem during the operation.
  • Sildenafil or tadalafil can add to silodosin's blood pressure drop, so your prescriber should know if you use either.
  • If swallowing is hard, the capsule can be opened and the powder sprinkled on a spoonful of applesauce.
How you get itPrescription only
Comes asCapsule
Earliest FDA record2006
Companies listing it with the FDA13
FDA label last updatedNov 28, 2025
FDA’s strongest warning (boxed)None on the label

Patient information guide A plain-language walkthrough of Silodosin, written from its FDA label.

What Silodosin is used for

▾

Silodosin is used for one condition:

  • Signs and symptoms of benign prostatic hyperplasia (BPH), or enlarged prostate (silodosin capsules, taken by mouth)
  • It is not used for high blood pressure.

How Silodosin works

▾

Silodosin blocks alpha-1 receptors in the prostate, bladder base, bladder neck, prostatic capsule and urethra. This relaxes smooth muscle in those tissues. The result is better urine flow and fewer BPH symptoms.

It binds most strongly to the alpha-1A subtype of these receptors.

Silodosin dosage

▾

Silodosin comes as a capsule taken by mouth once daily with a meal.

  • Food helps lower the risk of side effects, and the clinical trials were done with food.
  • If swallowing is hard, open the capsule and sprinkle the powder on a spoonful of soft, not hot, applesauce. Swallow it right away (within 5 minutes) without chewing, then drink a glass of cool water.
  • Do not split the capsule contents or save the mixture.
  • People with moderate kidney problems need a lower dose from their prescriber.

Dosing details from the FDA-approved label

From the Silodosin prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Usual dose (recommended dose)
    • 8 mg orally once daily with a meal
    • Patients who have difficulty swallowing may carefully open the capsule and sprinkle the powder on a tablespoonful of applesauce, swallowed immediately (within 5 minutes) without chewing, followed with an 8 oz glass of cool water
    • Take with a meal; applesauce should not be hot; do not store powder/applesauce mixture; subdividing the contents of a capsule is not recommended
  • Moderate renal impairment (CCr 30 mL/min -50 mL/min)
    • 4 mg once daily taken with a meal
    • Dose reduced from 8 mg; contraindicated in severe renal impairment (CCr less than 30 mL/min)
  • Mild renal impairment (CCr 50 mL/min - 80 mL/min)
    • No dosage adjustment is needed
  • Mild or moderate hepatic impairment
    • No dosage adjustment is needed
    • Not studied in severe hepatic impairment (Child-Pugh score greater than or equal to 10); contraindicated in these patients
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION 8 mg capsules taken orally once daily with a meal. ( 2.1 ) 4 mg capsules taken orally once daily with a meal for those with moderate renal impairment [Creatinine Clearance (CCr) 30 mL/min -50 mL/min]. (2.2 ) 2.1 Dosing Information The recommended dose is 8 mg orally once daily with a meal. Patients who have difficulty swallowing pills and capsules may carefully open the silodosin capsule and sprinkle the powder inside on a tablespoonful of applesauce. The applesauce should be swallowed immediately (within 5 minutes) without chewing and followed with an 8 oz glass of cool water to ensure complete swallowing of the powder. The applesauce used should not be hot, and it should be soft enough to be swallowed without chewing. Any powder/applesauce mixture should be used immediately (within 5 minutes) and not stored for future use. Subdividing the contents of a silodosin capsule is not recommended [see Clinical Pharmacology ( 12.3 )]. 2.2 Dosage Adjustment in Special Populations Renal impairment: Silodosin capsules are contraindicated in patients with severe renal impairment (CCr less than 30 mL/min). In patients with moderate renal impairment (CCr 30 mL/min -50 mL/min), the dose should be reduced to 4 mg once daily taken with a meal. No dosage adjustment is needed in patients with mild renal impairment (CCr 50 mL/min - 80 mL/min) [see Contraindications ( 4 ), Warnings and Precautions ( 5.2 ), Use in Specific Populations ( 8.6 ), and Clinical Pharmacology ( 12.3 )]. Hepatic impairment: Silodosin capsules has not been studied in patients with severe hepatic impairment (Child-Pugh score greater than or equal to 10) and is therefore contraindicated in these patients. No dosage adjustment is needed in patients with mild or moderate hepatic impairment [see Contraindications ( 4 ), Warnings and Precautions ( 5.3 ), Use in Specific Populations ( 8.7 ), and Clinical Pharmacology ( 12.3 )].

Read the full Dosage and Administration section on DailyMed →

Silodosin side effects

▾

Most side effects are mild. Common ones include:

Common side effects

  • Retrograde ejaculation (semen goes backward into the bladder; reversible after stopping)
  • Dizziness
  • Diarrhea
  • Low blood pressure when standing (orthostatic hypotension)
  • Headache
  • Stuffy or runny nose, nasopharyngitis (cold-like symptoms)
  • Nasal congestion

When to get medical help

  • Fainting or severe dizziness, especially when you start treatment or stand up
  • Allergic-type reactions such as swollen tongue or throat, trouble breathing, hives or a serious rash
  • Yellowing of the skin or eyes (jaundice) or signs of liver problems
  • A painful erection that does not go away (priapism; one case was reported in trials)
  • Before cataract surgery, tell your eye surgeon you take silodosin

Silodosin warnings and precautions

▾
  • Low blood pressure and fainting: This can happen when you start treatment. Use caution with driving or hazardous tasks at first.
  • Kidney and liver disease: Not for severe kidney or liver disease. Moderate kidney disease needs a lower dose.
  • Prostate cancer: It causes similar symptoms to BPH, so you should be checked before treatment.
  • Cataract surgery: Tell your eye surgeon about silodosin because of Intraoperative Floppy Iris Syndrome.
  • Allergic reactions: Serious ones, including swollen tongue and throat, have been reported after approval.

Silodosin interactions

▾

Several medicines can raise silodosin levels or add to its blood pressure effects.

  • Strong CYP3A4 inhibitors (ketoconazole, clarithromycin, itraconazole, ritonavir): contraindicated, as they greatly raise silodosin levels.
  • Moderate CYP3A4 inhibitors (diltiazem, erythromycin, verapamil): may raise levels; use caution.
  • Cyclosporine and other strong P-gp inhibitors: not recommended.
  • Other alpha-blockers: not to be combined.
  • PDE5 inhibitors (sildenafil, tadalafil): may lower blood pressure and cause symptoms.
  • Blood pressure medicines: use caution and watch for dizziness.
  • Probenecid, valproic acid, fluconazole: may increase silodosin exposure.
  • Digoxin: no dose change needed.

Interactions listed in the FDA-approved label

From the Silodosin prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Strong CYP3A4 inhibitors (e.g., itraconazole, ritonavir, ketoconazole): A 3.8-fold increase in silodosin maximum plasma concentrations and 3.2-fold increase in exposure were observed with 400 mg ketoconazole; strong CYP3A4 inhibitors may cause plasma concentrations of silodosin to increase. Concomitant administration is contraindicated.
  • Moderate CYP3A4 inhibitors (e.g., diltiazem, erythromycin, verapamil): May increase concentration of silodosin; the effect has not been evaluated. Exercise caution and monitor patients for adverse events.
  • Strong P-glycoprotein inhibitors (e.g., cyclosporine): Inhibition of P-gp may lead to increased silodosin concentration. Concomitant use is not recommended.
  • Other alpha-blockers: Pharmacodynamic interactions have not been determined, but interactions may be expected. Should not be used in combination with other alpha-blockers.
  • Digoxin: Did not significantly alter the steady state pharmacokinetics of digoxin (0.25 mg/day for 7 days). No dose adjustment is required.
  • PDE5 inhibitors (sildenafil, tadalafil): The total number of positive orthostatic test results was greater with silodosin plus a PDE5 inhibitor than with silodosin alone; no symptomatic orthostasis or dizziness was reported in the study, but concomitant use with alpha-blockers can potentially cause symptomatic hypotension.
  • Antihypertensives: Incidence of dizziness and orthostatic hypotension was higher in patients using concomitant antihypertensives than in the general silodosin population (4.6% versus 3.8% and 3.4% versus 3.2%, respectively). Exercise caution during concomitant use and monitor patients for possible adverse events.
  • Cytochrome P450 enzyme systems (metabolic interactions): In vitro data indicate silodosin does not have the potential to inhibit or induce cytochrome P450 enzyme systems.
  • Food (moderate fat, moderate calorie meal): Silodosin Cmax decreased by approximately 18% - 43% and AUC by 4% - 49% across three studies; effect was variable. Take silodosin with a meal to reduce risk of adverse events.
Read the label’s full interactions text

7 DRUG INTERACTIONS Strong P-glycoprotein inhibitors (e.g., cyclosporine): Co-administration may increase plasma silodosin concentration. Concomitant use is not recommended. ( 7.2 ) Alpha-blockers: Interactions involving concomitant use have not been determined. However, interactions are expected and concomitant use is not recommended. ( 7.3 ) Concomitant use of PDE5 inhibitors with alpha-blockers including silodosin can potentially cause symptomatic hypotension. ( 5.5 , 7.5 ) 7.1 Moderate and Strong CYP3A4 Inhibitors In a clinical metabolic inhibition study, a 3.8-fold increase in silodosin maximum plasma concentrations and 3.2-fold increase in silodosin exposure were observed with concurrent administration of a strong CYP3A4 inhibitor, 400 mg ketoconazole. Use of strong CYP3A4 inhibitors such as itraconazole or ritonavir may cause plasma concentrations of silodosin to increase. Concomitant administration of strong CYP3A4 inhibitors and silodosin capsules are contraindicated [see Contraindications ( 4 ), Warnings and Precautions ( 5.4 ) and Clinical Pharmacology ( 12.3 )]. The effect of moderate CYP3A4 inhibitors on the pharmacokinetics of silodosin has not been evaluated. Concomitant administration with moderate CYP3A4 inhibitors (e.g., diltiazem, erythromycin, verapamil) may increase concentration of silodosin. Exercise caution and monitor patients for adverse events when co-administering silodosin capsules with moderate CYP3A4 inhibitors. 7.2 Strong P-glycoprotein (P-gp) Inhibitors In vitro studies indicated that silodosin is a P-gp substrate. Ketoconazole, a CYP3A4 inhibitor that also inhibits P-gp, caused significant increase in exposure to silodosin. Inhibition of P-gp may lead to increased silodosin concentration. Silodosin capsules are therefore not recommended in patients taking strong P-gp inhibitors such as cyclosporine [see Clinical Pharmacology ( 12.3 )].

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Before taking Silodosin

▾
  • Do not use with severe kidney disease or severe liver disease.
  • Do not use if allergic to silodosin or its ingredients.
  • Moderate kidney disease: lower dose and monitoring.
  • Not indicated for women, including during pregnancy.
  • Not indicated for children; safety has not been established.
  • Older adults had somewhat higher drug exposure and should report dizziness.
  • Plan to see an eye surgeon? Mention silodosin first.

Silodosin overdose

▾

In studies of healthy men at up to 48 mg a day, the main problem was low blood pressure on standing. If too much is taken and blood pressure drops, care focuses on supporting the heart and circulation. Lying flat may help, and IV fluids or medicines to raise blood pressure may be used. Dialysis is unlikely to help. Seek emergency help.

What Silodosin does in the body

▾

In 12-week trials, a small number of people had a blood pressure or heart rate change on standing, slightly more often than with placebo. Silodosin did not lengthen the QT interval (a heart rhythm measurement) in a study of healthy men.

How your body processes Silodosin

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About 32% of silodosin is absorbed into the bloodstream. Food can lower blood levels by a variable amount. Peak levels occur at about 2.6 hours and the half-life is about 13 hours. It is broken down in the liver, and its main metabolite is active and lasts about 24 hours. It leaves the body through feces and urine.

How to store Silodosin

▾

Store at 20° to 25°C (68° to 77°F) . Protect from light and moisture. Keep out of reach of children.

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

145

Supplements & herbs that interact with Silodosin

145 supplements and herbal products have documented interactions with Silodosin in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 3
  • Moderate · 104
  • Minor · 38
Every supplement checked against Silodosin — ranked by severity The full interaction hub: 3 major · 104 moderate · 38 minor · every one linked to its full report. Check Silodosin against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

Silodosin: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Silodosin — the kind of thing our pharmacy team would talk through with you at the counter.

What is silodosin for?

▾
It treats the symptoms of an enlarged prostate (BPH), such as poor urine flow. It relaxes muscle in the prostate and bladder area. It is not a blood pressure medicine.

How should I take it?

▾
Take one capsule once a day with a meal. If swallowing is hard, you can sprinkle the powder from an opened capsule on a spoonful of applesauce, swallow it right away, and follow with a glass of water. Follow your prescriber's directions.

What side effects should I expect?

▾
The most common is retrograde ejaculation, where semen goes backward, which goes away after stopping. Dizziness, diarrhea, headache and a stuffy nose can also happen. Stand up slowly at first.

When should I call my doctor?

▾
Call if you faint, feel very dizzy, have swelling of the tongue or throat, a serious rash, or yellowing of your skin or eyes. Get help right away for an erection that will not go away.

Can I take it with my other medicines?

▾
Not always. Some antifungals and antibiotics, like ketoconazole and clarithromycin, and ritonavir must not be used with it. Tell me about any blood pressure pills, other prostate alpha-blockers, or erectile dysfunction medicines so we can check.

Do I need to tell my eye doctor?

▾
Yes, if you plan cataract surgery. Alpha-blockers like silodosin can cause a small-pupil problem called Intraoperative Floppy Iris Syndrome, and your surgeon needs to know.

Is Silodosin available over the counter?

▾
No. Silodosin is a prescription medicine: every Silodosin product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Silodosin first available?

▾
The earliest FDA record we hold for Silodosin is from 2006: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Silodosin was first used.

Who makes Silodosin?

▾
13 companies currently list Silodosin products in the FDA's NDC Directory, including Amneal Pharmaceuticals NY LLC, Bryant Ranch Prepack, Ajanta Pharma USA Inc.. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Silodosin on HelloPharmacist

Detailed data & references for Silodosin Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Silodosin forms and strengths (how it comes)

Silodosin is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Capsule

By mouth
Brands Rapaflo
How this form is used
What it may be used for
  • Silodosin capsules are used to treat the signs and symptoms of benign prostatic hyperplasia (BPH).
  • Silodosin capsules are not indicated for high blood pressure.
Important instructions
  • Silodosin capsules are taken by mouth once daily with a meal.
  • Silodosin capsules can be opened and the powder sprinkled on applesauce if swallowing is hard; swallow within 5 minutes without chewing, then drink a glass of cool water.
  • Do not divide the contents of a silodosin capsule or store the applesauce mixture for later.
Available strengths 2 strengths
57 FDA-listed product records ⓘ

Silodosin on the U.S. market: products, makers and brands

How Silodosin appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

13 companies list 29 Silodosin product records with the FDA, mostly as capsule; the earliest marketing or approval year on record is 2006. Brand names on the directory include Rapaflo; the rest are generics.

1
Dose forms ⓘ
13
Labelers (makers, repackagers, distributors)
1
Brand names
29
FDA-listed product records ⓘ
2006
Earliest FDA record ⓘ

Also listed with the FDA, not a patient dose form: Powder (11) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Amneal Pharmaceuticals NY LLC14%
Bryant Ranch Prepack10%
Ajanta Pharma USA Inc.7%
Alembic Pharmaceuticals Inc.7%
Alembic Pharmaceuticals Limited7%
Aurobindo Pharma Limited7%
Other makers48%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Silodosin is used (Medicaid data)

A general measure of how commonly Silodosin is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Silodosin is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

6,899
Medicaid prescriptions filled (Q1–Q4 2025)
$175,862 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Silodosin prescribed? Of the 1,601 medications we measure, Silodosin ranks #994 by Medicaid prescriptions — more than 38% of them.

Where Silodosin ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Silodosin product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 8 mg oral capsule is the most-dispensed Silodosin product — about 71% of these Medicaid prescriptions.

silodosin 8 MG Oral Capsule Most dispensed

4,893 Medicaid prescriptions (Q1–Q4 2025) 71% of Silodosin prescriptions shown $132,053 gross reimbursement (before rebates) ≈ $27 per prescription (gross)

Summed across the 12 of 41 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 809477

silodosin 4 MG Oral Capsule

2,006 Medicaid prescriptions (Q1–Q4 2025) 29% of Silodosin prescriptions shown $43,809 gross reimbursement (before rebates) ≈ $22 per prescription (gross)

Summed across the 7 of 33 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 826612

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Silodosin, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 19 of 74 listed Silodosin NDCs with Medicaid activity.

Compare Silodosin products

A representative set of FDA-listed product records for Silodosin — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 29 of 29 products — FDA National Drug Code Directory. See every product, package size and price: browse all 29 Silodosin NDCs →

Silodosin side effects reported to the FDA (FAERS)

After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Silodosin — a signal of what to watch for, not proof the drug caused it.

The effects most often named in FDA reports that mention Silodosin are diarrhoea, fatigue, dizziness; about 88% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.

3,956
Reports mentioning it
88%
Reported as serious
12
Distinct effects shown
Most reported effects
Diarrhoea
156
Fatigue
150
Dizziness
141
Acute Kidney Injury
139
Anaemia
126
Asthenia
124
Hypotension
123
Urinary Retention
121
Pyrexia
120
Drug Interaction
119
Age groups
Elderly · 816Adult · 135Neonate · 1Child · 1

Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Silodosin in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.

Silodosin FDA approval history

How Silodosin went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.

Silodosin was first approved by the FDA in 2006; the first generic version was approved in 2017. It remains available in U.S. pharmacies today.

2006
First FDA approval
2017
First generic approved
Lower-cost ANDA competition begins
2026
Available today
Active in U.S. pharmacies

Source: Drugs@FDA.

Silodosin recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list one Silodosin recall since July 2021. It is still ongoing. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Ongoing Class II Feb 4, 2025 · 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 105%)
  • Silodosin Capsules, 8mg, 90-count bottle, Rx only, Manufactured for: AvKare, Pulaski, TN 38478, Manufactured by: Amneal Pharmaceuticals of NY, LLC, NY 11719, NDC 42291-778-90 Lots: Lot#: BC20223A, Exp. March 31, 2025. FDA record D-0229-2025 →

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Silodosin RxCUI 720825 1 dose form · 2 strengths
  1. Dose form (SCDF) Oral Capsule RxCUI 809476 In current FDA listings
    Clinical drug / strength (SCD) 4 MG RxCUI 826612 8 MG RxCUI 809477

Look up RxCUI 720825 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Silodosin costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Capsule · Oral 8 mg $0.319 per capsule NDC details & price history
Capsule · Oral 4 mg $0.265 per capsule NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Silodosin brand names

Silodosin is sold under one brand name in the FDA directory — Rapaflo. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Rapaflo

Who makes Silodosin: manufacturers and labelers

13 companies list Silodosin products with the FDA. By number of product records, the largest are Amneal Pharmaceuticals NY LLC, Bryant Ranch Prepack, Ajanta Pharma USA Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Amneal Pharmaceuticals NY LLC 4 Bryant Ranch Prepack 3 Ajanta Pharma USA Inc. 2 Alembic Pharmaceuticals Inc. 2 Alembic Pharmaceuticals Limited 2 Aurobindo Pharma Limited 2 AvKARE 2 Camber Pharmaceuticals, Inc. 2 Creekwood Pharmaceuticals LLC 2 Lupin Pharmaceuticals, Inc. 2 Macleods Pharmaceuticals Limited 2 Novadoz Pharmaceuticals LLC 2 PD-Rx Pharmaceuticals, Inc. 2

Silodosin drug class (RxNorm)

Silodosin belongs to the alpha-Adrenergic Blocker class.

Pharmacologic class alpha-Adrenergic Blocker
Drug family (ATC) Alpha-adrenoreceptor antagonists
How it works Adrenergic alpha-Antagonists

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Silodosin page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Nov 28, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Silodosin.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Silodosin after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
17
Finished products in the current FDA directory
29
Companies listing them (makers, repackagers, distributors)
13
FDA labeler codes behind them ⓘ
15
Linked representative label ⓘ
Ajanta Pharma USA Inc.
Linked label effective
Nov 28, 2025
Composite sections available
22
Linked SPL Set ID
e863be56-d303-43bb-915a-1b2568674e31
Linked SPL Document ID
ae59631d-37e7-4fab-b160-fdfad41f6ce2
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Ajanta Pharma USA Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →