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Vardenafil

Vardenafil is a PDE5 inhibitor used to treat erectile dysfunction in adult men.

Brand names LevitraStaxyn
Drug class Phosphodiesterase 5 Inhibitors
Rx Forms 2
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 22 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
Vardenafil 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

Vardenafil (Levitra, Staxyn) treats erectile dysfunction by increasing blood flow to the penis in response to sexual stimulation. It is a PDE5 inhibitor, a standard first choice like its better-known cousins sildenafil and tadalafil, on the U.S. market since about 2003 and available generically. Most men tolerate it well, and headache, flushing and a stuffy nose are what people usually notice. Never combine it with nitrates such as nitroglycerin for chest pain, or with guanylate cyclase stimulators such as riociguat, because blood pressure can drop dangerously. Get help right away for an erection lasting over 4 hours or sudden loss of vision or hearing.

Clinical pearls

  • The dissolving tablet (Staxyn) goes on the tongue straight from the blister pack, with no water or other liquid.
  • Take the regular tablet about an hour before sex, with or without food, and no more than once a day.
  • Alpha-blockers like tamsulosin add to vardenafil's blood pressure drop, and Staxyn should not be started by men already taking one.
  • Clarithromycin, ritonavir, ketoconazole and grapefruit juice raise vardenafil levels, so tell any new prescriber you use it and skip grapefruit.
How we write & review this content — our editorial policy →
How you get itPrescription only
Comes asTablet, Orally disintegrating tablet
Earliest FDA record2003
Companies listing it with the FDA11
FDA label last updatedJul 30, 2025
FDA’s strongest warning (boxed)None on the label

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

What Vardenafil is used for

▾

Vardenafil is approved for one indication across all its supported products:

  • Erectile dysfunction: Both Vardenafil and Vardenafil Hydrochloride tablets (film-coated/standard) and Vardenafil orally disintegrating tablets are indicated for the treatment of erectile dysfunction in adult men. Sexual stimulation is required for vardenafil to produce an erection.

How Vardenafil works

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During sexual arousal, the body releases nitric oxide in the penis, which triggers the production of a chemical called cGMP. cGMP causes smooth muscle in the penis to relax, allowing blood to flow in and produce an erection. Vardenafil works by blocking an enzyme called PDE5 (phosphodiesterase type 5) that normally breaks down cGMP — so by blocking PDE5, vardenafil keeps cGMP levels higher for longer, supporting the ability to get and maintain an erection. Because this process depends on sexual stimulation to release nitric oxide in the first place, vardenafil has no effect without arousal.

Vardenafil dosage

▾

Vardenafil is taken by mouth as needed, approximately 60 minutes before sexual activity, and no more than once per day. The standard tablet form (Vardenafil, Vardenafil Hydrochloride) can be taken with or without food. The orally disintegrating tablet form (Vardenafil) is placed on the tongue to dissolve and must be taken without any liquid, immediately after opening the blister pack — it can also be taken with or without food.

  • The orally disintegrating tablet is not interchangeable with the standard film-coated tablet; they deliver different amounts of drug into the bloodstream
  • Patients who need a lower or higher dose than the orally disintegrating tablet provides must use the tablet form instead
  • Older adults (65 and over) and those with moderate liver disease should discuss a lower starting dose of the tablet form with their prescriber
  • Always follow your prescriber's specific instructions — dose may be adjusted based on how well it works and how well you tolerate it

Dosing details from the FDA-approved label

From the Vardenafil 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.

  • Most patients (general dosing)
    • Starting dose is 10 mg, taken orally as needed, approximately 60 minutes before sexual activity, up to once daily
    • May be increased to 20 mg or decreased to 5 mg based on efficacy and side effects
    • Maximum: 20 mg; maximum recommended dosing frequency is once per day
    • May be taken with or without food; sexual stimulation is required for a response
  • Patients ≥65 years of age
    • A starting dose of 5 mg should be considered
    • Geriatric starting dose
  • Moderate hepatic impairment (Child-Pugh B)
    • Starting dose of 5 mg is recommended
    • Maximum: Should not exceed 10 mg
    • Do not use in severe hepatic impairment (Child-Pugh C)
  • Patients on renal dialysis
    • Do not use vardenafil hydrochloride tablets
    • Not for use in patients on renal dialysis
  • Patients stable on alpha-blocker therapy
    • Initiate at a dose of 5 mg (2.5 mg when used concomitantly with certain CYP3A4 inhibitors)
    • Initiate only if stable on alpha-blocker; a time interval between dosing should be considered
  • Taking ritonavir
    • No more than 2.5 mg in a 72-hour period
    • Maximum: 2.5 mg in a 72-hour period
    • Strong CYP3A4 inhibitor adjustment
  • Taking cobicistat
    • No more than 2.5 mg in a 72-hour period
    • Maximum: 2.5 mg in a 72-hour period
    • Strong CYP3A4 inhibitor adjustment
  • Taking indinavir, saquinavir, atazanavir, ketoconazole 400 mg daily, itraconazole 400 mg daily, or clarithromycin
    • No more than 2.5 mg in a 24-hour period
    • Maximum: 2.5 mg in a 24-hour period
    • CYP3A4 inhibitor adjustment
  • Taking ketoconazole 200 mg daily, itraconazole 200 mg daily, or erythromycin
    • No more than 5 mg in a 24-hour period
    • Maximum: 5 mg in a 24-hour period
    • CYP3A4 inhibitor adjustment
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION Vardenafil hydrochloride tablets are taken as needed: For most patients, the starting dose is 10 mg, up to once daily. Increase to 20 mg or decrease to 5 mg based on efficacy/tolerability. ( 2.1 ) A starting dose of vardenafil hydrochloride tablets, 5 mg should be considered in patients ≥65 years of age. ( 2.3 ) Vardenafil hydrochloride tablets are taken orally, approximately 60 minutes before sexual activity. ( 2.1 ) The maximum recommended dosing frequency is one tablet per day. ( 2.1 ) Vardenafil hydrochloride tablets may be taken with or without food. ( 2.2 ) If taking strong or moderate inhibitors of CYP3A4, the dose of vardenafil hydrochloride tablets should be adjusted as follows ( 2.4 , 5.2 , 7.2 ): Ritonavir: No more than 2.5 mg in a 72-hour period Cobicistat: No more than 2.5 mg in a 72-hour period Indinavir, saquinavir, atazanavir, ketoconazole 400 mg daily, itraconazole 400 mg daily, clarithromycin: No more than 2.5 mg in a 24-hour period Ketoconazole 200 mg daily, itraconazole 200 mg daily, erythromycin: No more than 5 mg in a 24-hour period. In patients on stable alpha-blocker therapy the recommended starting dose of vardenafil hydrochloride tablets is 5 mg ( 2.4 , 5.6 ) The recommended starting dose of vardenafil hydrochloride tablets is 5 mg in patients with moderate hepatic impairment (Child-Pugh B). The maximum dose in patients with moderate hepatic impairment should not exceed 10 mg. ( 2.3 , 8.6 ) 2.1 General Dose Information For most patients, the recommended starting dose of vardenafil hydrochloride tablets is 10 mg, taken orally, as needed, approximately 60 minutes before sexual activity. The dose may be increased to a maximum recommended dose of 20 mg or decreased to 5 mg based on efficacy and side effects. The maximum recommended dosing frequency is once per day. Sexual stimulation is required for a response to treatment. 2.2 Use with Food Vardenafil hydrochloride tablets can be taken with or without food. 2.3 Use in Specific Populations Geriatrics: A starting dose of vardenafil hydrochloride tablets, 5 mg should be considered in patients ≥65 years of age [see Use in Specific Populations ( 8.5 )] . Hepatic Impairment: For patients with moderate hepatic impairment (Child-Pugh B), a starting dose of vardenafil hydrochloride tablets, 5 mg is recommended.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Vardenafil side effects

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The most common side effects reported with vardenafil include:

Common side effects

  • Headache
  • Flushing (feeling of warmth or redness)
  • Stuffy or runny nose
  • Upset stomach (dyspepsia)
  • Sinus congestion
  • Dizziness
  • Nausea
  • Back pain

When to get medical help

  • Get emergency help right away if you have an erection lasting more than 4 hours — this is a medical emergency that can cause permanent damage
  • Stop taking vardenafil and call your doctor immediately if you experience sudden loss of vision in one or both eyes
  • Stop taking vardenafil and seek medical attention right away if you have a sudden decrease or total loss of hearing, which may come with ringing in the ears or dizziness
  • Call your doctor if you feel faint, dizzy, or lightheaded — especially if you also take alpha-blockers or blood pressure medications
  • Do not take vardenafil if you take nitrates (such as nitroglycerin) for chest pain — the combination can cause a dangerous drop in blood pressure
  • Seek prompt medical care for any signs of a severe allergic reaction

These effects are generally mild and more likely at higher doses. Seek immediate medical help for serious reactions such as an erection lasting more than 4 hours, sudden vision loss, sudden hearing loss, or severe dizziness — these require urgent care.

Vardenafil warnings and precautions

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  • Never combine with nitrates or nitric oxide donors (e.g., nitroglycerin for chest pain): this can cause a sudden, life-threatening drop in blood pressure. This combination is strictly contraindicated.
  • Never combine with guanylate cyclase stimulators (e.g., riociguat): same risk of severe low blood pressure.
  • Prolonged erection (priapism): An erection lasting more than 4 hours is a medical emergency. Without prompt treatment, permanent damage to penile tissue can occur.
  • Sudden vision loss: Rare cases of NAION (nonarteritic anterior ischemic optic neuropathy — a type of sudden vision loss due to reduced blood flow to the optic nerve) have been reported. Stop vardenafil and get medical help immediately if this happens.
  • Sudden hearing loss: Cases of sudden decrease or loss of hearing, sometimes with ringing in the ears or dizziness, have been reported. Stop vardenafil and seek prompt medical attention.
  • Heart health: There is some cardiac risk associated with sexual activity. Vardenafil should not be used in men for whom sex is medically inadvisable due to heart conditions such as unstable angina, very high or very low blood pressure, or recent stroke or heart attack.
  • QT prolongation (a change in heart rhythm): Vardenafil can affect the heart's electrical activity. People with congenital long QT syndrome or taking Class IA or III antiarrhythmic medications should avoid vardenafil.
  • Alpha-blockers: Do not start the orally disintegrating tablet form if you are already on an alpha-blocker. Combining the two can cause a significant drop in blood pressure.

Vardenafil interactions

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Vardenafil interacts with several important drugs and substances — tell your doctor and pharmacist about everything you take:

  • Nitrates and nitric oxide donors (e.g., nitroglycerin, isosorbide): contraindicated — can cause dangerous drops in blood pressure
  • Guanylate cyclase stimulators (e.g., riociguat): contraindicated — same blood pressure risk
  • Alpha-blockers (e.g., tamsulosin, terazosin, alfuzosin): can cause additive blood pressure lowering and fainting; do not start the orally disintegrating tablet form if already taking one
  • Strong CYP3A4 inhibitors (e.g., ritonavir, cobicistat, indinavir, ketoconazole, itraconazole, clarithromycin): significantly raise vardenafil blood levels; the orally disintegrating tablet must not be used with these; strict dose limits apply to the tablet form
  • Moderate CYP3A4 inhibitors (e.g., erythromycin): raise vardenafil blood levels; dose limits apply to the tablet form
  • Antihypertensive medications: vardenafil may add to blood pressure-lowering effects
  • Grapefruit juice: likely increases vardenafil exposure by inhibiting the same enzyme that metabolizes it
  • Alcohol: no significant blood pressure interaction was found in a controlled study at moderate amounts, but caution is still advisable

Interactions listed in the FDA-approved label

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

  • Nitrates and nitric oxide donors: Vardenafil potentiated the blood pressure lowering effects of sublingual nitrates (0.4 mg) taken 1 and 4 hours after vardenafil 20 mg in healthy middle-aged subjects. Concomitant use is contraindicated.
  • Guanylate cyclase stimulators (such as riociguat): Concomitant use is contraindicated. Do not use together.
  • Alpha-blockers: Both are vasodilators with blood-pressure-lowering effects, so an additive effect on blood pressure may be anticipated. Use caution; initiate at 5 mg only if stable on alpha-blocker therapy, and consider a time interval between dosing.
  • Antihypertensives: Vardenafil may add to the blood pressure lowering effects of antihypertensive agents.
  • Alcohol: Vardenafil 20 mg did not potentiate the hypotensive effects of alcohol, and alcohol and vardenafil plasma levels were not altered.
  • Ketoconazole: Ketoconazole 200 mg once daily produced a 10-fold increase in vardenafil AUC and a 4-fold increase in Cmax. Do not exceed 5 mg in 24 hours with ketoconazole 200 mg daily; do not exceed a single 2.5 mg dose in 24 hours with ketoconazole 400 mg daily.
  • Indinavir: Indinavir resulted in a 16-fold increase in vardenafil AUC, a 7-fold increase in Cmax and a 2-fold increase in half-life. Do not exceed a single 2.5 mg dose in a 24-hour period.
  • Ritonavir: Ritonavir resulted in a 49-fold increase in vardenafil AUC and a 13-fold increase in Cmax, and prolonged vardenafil half-life to 26 hours. Do not exceed a single 2.5 mg dose in a 72-hour period.
  • Cobicistat: Cobicistat can result in increased vardenafil plasma concentrations. Do not exceed a single 2.5 mg dose in a 72-hour period.
  • Erythromycin: Erythromycin produced a 4-fold increase in vardenafil AUC and a 3-fold increase in Cmax. Do not exceed a single 5 mg dose in a 24-hour period.
Read the label’s full interactions text

7 DRUG INTERACTIONS Vardenafil hydrochloride tablets can potentiate the hypotensive effects of nitrates, alpha- blockers, and antihypertensives. ( 7.1 ) 7.1 Potential for Pharmacodynamic Interactions with Vardenafil Hydrochloride Tablets Nitrates: Concomitant use of vardenafil hydrochloride tablets and nitrates and nitric oxide donors is contraindicated. The blood pressure lowering effects of sublingual nitrates (0.4 mg) taken 1 and 4 hours after vardenafil and increases in heart rate when taken at 1, 4 and 8 hours after vardenafil were potentiated by a 20 mg dose of vardenafil hydrochloride tablets in healthy middle-aged subjects. These effects were not observed when vardenafil hydrochloride tablets 20 mg were taken 24 hours before the nitroglycerin (NTG). Potentiation of the hypotensive effects of nitrates for patients with ischemic heart disease has not been evaluated, and concomitant use of vardenafil hydrochloride tablets and nitrates is contraindicated [see Contraindications (4.1) and Clinical Pharmacology (12.2) . Alpha-Blockers: Caution is advised when PDE5 inhibitors are co-administered with alpha-blockers. PDE5 inhibitors, including vardenafil hydrochloride tablets and alpha-adrenergic blocking agents are both vasodilators with blood-pressure-lowering effects. When vasodilators are used in combination, an additive effect on blood pressure may be anticipated. Clinical pharmacology studies have been conducted with co-administration of vardenafil with alfuzosin, terazosin or tamsulosin. [See Dosage and Administration (2.4) , Warnings and Precautions (5.6) , and Clinical Pharmacology (12.2) .] Antihypertensives: Vardenafil hydrochloride tablets may add to the blood pressure lowering effects of antihypertensive agents.

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.

🌿144 supplements and herbs with documented Vardenafil interactions, ranked by severity Check Vardenafil against a supplement or herb →

Before taking Vardenafil

▾
  • Do not take vardenafil if you use nitrates for chest pain (e.g., nitroglycerin) or any nitric oxide donor — this combination is dangerous
  • Do not take vardenafil if you use a guanylate cyclase stimulator such as riociguat
  • Tell your doctor if you take alpha-blockers — special precautions apply, especially with the orally disintegrating tablet form
  • Tell your doctor about any heart problems, including recent heart attack or stroke, unstable angina, severe heart failure, or very high or very low blood pressure
  • Tell your doctor if you have moderate or severe liver disease — the orally disintegrating tablet must not be used; dose adjustments are needed for the tablet form in moderate liver impairment
  • Do not use vardenafil if you are on kidney dialysis
  • Older adults (65 and over) may need a lower starting dose of the tablet form due to higher drug levels in the blood
  • Vardenafil is not approved for children or women
  • Tell your doctor if you have a history of NAION (a type of sudden vision loss) or a 'crowded' optic disc — vardenafil should be used only with caution in these patients
  • Tell your doctor if you have a hereditary eye disease such as retinitis pigmentosa — vardenafil has not been evaluated in these patients
  • Tell your doctor if you have a personal or family history of long QT syndrome or take certain heart rhythm medications
  • If you have phenylketonuria (PKU), be aware that the orally disintegrating tablet contains phenylalanine
  • Tell your doctor if you have a condition that predisposes you to prolonged erections, such as sickle cell anemia, multiple myeloma, or leukemia

Vardenafil overdose

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Taking too much vardenafil can cause back pain, muscle aches, and abnormal vision, based on data from studies using high doses in healthy volunteers. If an overdose is suspected, standard supportive medical care should be sought. Kidney dialysis is not useful for removing vardenafil from the body because it binds tightly to proteins in the blood and is not significantly cleared through the urine.

What Vardenafil does in the body

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Vardenafil lowers blood pressure to a modest degree — studies with the film-coated tablet showed a mean maximum drop of about 7 mmHg in systolic (top number) and 8 mmHg in diastolic (bottom number) blood pressure, with a small increase in heart rate. This effect peaks between 1 and 4 hours after taking the dose. When vardenafil is combined with nitrates, blood pressure drops much more significantly and dangerously — this effect can persist for up to 8 hours after a dose. Vardenafil may also add to the blood pressure-lowering effects of antihypertensive medications and alpha-blockers.

How your body processes Vardenafil

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After taking the orally disintegrating tablet, vardenafil typically reaches its peak blood level in about 1.5 hours. Vardenafil is broken down mainly in the liver by an enzyme called CYP3A4, and its main breakdown product (metabolite M1) is also mildly active. The drug has a half-life (time for the body to clear half of it) of roughly 4 to 6 hours for the orally disintegrating tablet form. Most of the drug leaves the body through the feces, with only a small amount in the urine. The orally disintegrating tablet delivers more drug into the bloodstream than the standard 10 mg film-coated tablet, and it should not be swallowed with water, which reduces absorption. Older adults tend to have higher vardenafil blood levels than younger adults. Taking the orally disintegrating tablet with a high-fat meal can reduce peak drug levels somewhat, but does not change the total amount absorbed.

How to store Vardenafil

▾

Store at 25°C (77°F); excursions permitted within15-30°C (59-86°F) .

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

144

Supplements & herbs that interact with Vardenafil

144 supplements and herbal products have documented interactions with Vardenafil 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 · 5
  • Moderate · 98
  • Minor · 41
ACTIVATED CHARCOAL Major AMERICAN MISTLETOE Major GRAPEFRUIT Major HAWTHORN Major ST. JOHN'S WORT Major ACACIA RIGIDULA Moderate ADRAFINIL Moderate AFRICAN WILD POTATO Moderate +136 more
Every supplement checked against Vardenafil — ranked by severity The full interaction hub: 5 major · 98 moderate · 41 minor · every one linked to its full report. Check Vardenafil 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.

Vardenafil: pharmacist answers to common questions

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

How long before sex should I take vardenafil, and does it matter if I eat first?

▾
Generally, you should take vardenafil about 60 minutes before sexual activity — that's when it tends to work best. For the standard tablet, food doesn't really matter; you can take it with or without a meal. If you're using the orally disintegrating tablet, let it dissolve on your tongue without any liquid, and take it right away after opening the blister pack. A high-fat meal may slightly reduce peak absorption with the orally disintegrating form, but it can still be taken with food. Just remember — you still need to be sexually aroused for it to work.

Can I take vardenafil with my other heart or blood pressure medications?

▾
This is really important to go over with your doctor. If you take any nitrate medications — like nitroglycerin for chest pain — you absolutely cannot take vardenafil. The combination can cause a dangerous, potentially life-threatening drop in blood pressure. Similarly, if you take a drug called riociguat, the two must not be combined. Blood pressure medications in general may have an added lowering effect when combined with vardenafil, so your doctor needs to know everything you take. If you're on alpha-blockers for your prostate or blood pressure, there are extra precautions as well — don't start the orally disintegrating tablet form if you're already on one of those.

What side effects should I expect, and which ones mean I need to call for help right away?

▾
The most common side effects are headache, flushing (that warm, red feeling), a stuffy nose, and sometimes an upset stomach or dizziness — these are usually mild and tend to ease up over time. The ones that need immediate medical attention are a prolonged erection lasting more than 4 hours (even if it's not painful — don't wait), any sudden loss of vision in one or both eyes, or a sudden drop in hearing ability. These are rare but serious, and you should stop vardenafil and get medical help right away if any of them happen.

I've heard the dissolving tablet and the regular tablet are different — is that true?

▾
Yes, and this is worth knowing. The orally disintegrating tablet (the kind that dissolves on your tongue) actually delivers more of the drug into your bloodstream than the standard 10 mg film-coated tablet. They are not interchangeable. If your dose needs to be adjusted up or down, you would need to switch to the standard tablet form instead. Also, the dissolving tablet must not be swallowed with water — that actually reduces how much of the drug your body absorbs. Take it right out of the blister pack and let it dissolve on your tongue.

Does vardenafil work on its own, or do I need to be in the mood for it to do anything?

▾
You do need to be sexually aroused — vardenafil won't produce an erection on its own. The way it works, it depends on your body first releasing a natural chemical (nitric oxide) in response to sexual stimulation. Vardenafil then helps that signal last longer and work more effectively. Think of it as supporting your body's natural response, not replacing it.

I'm 70 years old — is vardenafil safe for me to take?

▾
Vardenafil has been studied in men over 65, and it can be used in older adults — but your body tends to process the drug more slowly as you age, so blood levels can run higher than in younger men. Because of this, your doctor will likely start you on a lower dose of the tablet form. Make sure to mention all your other medications and any heart, liver, or kidney conditions, since these affect which form and dose are right for you.

Is Vardenafil available over the counter?

▾
No. Vardenafil is a prescription medicine: every Vardenafil 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 Vardenafil first available?

▾
The earliest FDA record we hold for Vardenafil is from 2003: 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 Vardenafil was first used.

Who makes Vardenafil?

▾
11 companies currently list Vardenafil products in the FDA's NDC Directory, including Bryant Ranch Prepack, Alembic Pharmaceuticals Inc., Alembic Pharmaceuticals Limited. 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 Vardenafil on HelloPharmacist

📊Vardenafil supplement interactions144 checked — ranked by severity 🌿Drug & Supplement CheckerVardenafil vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Vardenafil NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Vardenafil 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.

Vardenafil forms and strengths (how it comes)

Vardenafil is available in 2 forms. 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.

Tablet

By mouth
How this form is used
What it may be used for
  • Vardenafil and Vardenafil Hydrochloride tablets are used to treat erectile dysfunction in adult men
Important instructions
  • Vardenafil Hydrochloride tablets are taken by mouth approximately 60 minutes before sexual activity, no more than once per day
  • Vardenafil Hydrochloride tablets may be taken with or without food
  • Older adults (65 and over) should discuss starting at a lower dose of Vardenafil Hydrochloride tablets with their prescriber
  • Vardenafil Hydrochloride tablets should not be used in patients with severe liver impairment; a lower starting dose and maximum dose limit applies in moderate liver impairment
Available strengths 5 strengths
2.5 mg 5 mg 10 mg 11.85 mg 20 mg
94 FDA-listed product records ⓘ

Orally disintegrating tablet

By mouth
How this form is used
What it may be used for
  • Vardenafil orally disintegrating tablets are used to treat erectile dysfunction in adult men
Important instructions
  • Vardenafil orally disintegrating tablets should be placed on the tongue and allowed to dissolve — do not swallow with water or any other liquid
  • Vardenafil orally disintegrating tablets should be taken immediately upon removal from the blister pack
  • Vardenafil orally disintegrating tablets may be taken with or without food and are taken approximately 60 minutes before sexual activity, no more than once per day
  • Vardenafil orally disintegrating tablets are not interchangeable with vardenafil film-coated tablets and should not be used in patients on alpha-blockers, strong or moderate CYP3A4 inhibitors, or moderate-to-severe liver impairment
Available strengths 1 strength
10 mg
5 FDA-listed product records ⓘ

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

How Vardenafil 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.

11 companies list 43 Vardenafil product records with the FDA, mostly as tablet, orally disintegrating tablet; the earliest marketing or approval year on record is 2003. Brand names on the directory include Levitra, Staxyn; the rest are generics.

2
Dose forms ⓘ
11
Labelers (makers, repackagers, distributors)
2
Brand names
43
FDA-listed product records ⓘ
2003
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (27) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Bryant Ranch Prepack14%
Alembic Pharmaceuticals Inc.12%
Alembic Pharmaceuticals Limited12%
Macleods Pharmaceuticals Limited12%
Lannett Company, Inc.9%
Teva Pharmaceuticals USA, Inc.9%
Other makers33%

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

Compare Vardenafil products

A representative set of FDA-listed product records for Vardenafil — 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 43 of 43 products — FDA National Drug Code Directory. See every product, package size and price: browse all 43 Vardenafil NDCs →

Vardenafil 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 no Vardenafil recalls since July 2021.

✅No Vardenafil recalls on record since July 2021

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) Vardenafil RxCUI 306674 2 dose forms · 5 strengths
  1. Dose form (SCDF) Disintegrating Oral Tablet RxCUI 996178 In current FDA listings
    Clinical drug / strength (SCD) 10 MG RxCUI 996179
  2. Dose form (SCDF) Oral Tablet RxCUI 378688 In current FDA listings
    Clinical drug / strength (SCD) 2.5 MG RxCUI 402273 5 MG RxCUI 349478 10 MG RxCUI 349479 20 MG RxCUI 349480

Look up RxCUI 306674 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 Vardenafil 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
Tablet, Film Coated · Oral 20 mg $2.79 per tablet NDC details & price history
Tablet, Film Coated · Oral 5 mg $7.10 per tablet NDC details & price history
Tablet, Film Coated · Oral 10 mg $2.87 per tablet NDC details & price history
Tablet · Oral 20 mg $2.79 per tablet NDC details & price history
Tablet · Oral 10 mg $2.87 per tablet NDC details & price history
Tablet · Oral 5 mg $7.10 per tablet NDC details & price history
Tablet · Oral 11.85 mg $23.33 per tablet 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.

Vardenafil brand names

Vardenafil is sold under 2 brand names in the FDA directory — Levitra, Staxyn. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Levitra Staxyn

Who makes Vardenafil: manufacturers and labelers

11 companies list Vardenafil products with the FDA. By number of product records, the largest are Bryant Ranch Prepack, Alembic Pharmaceuticals Inc., Alembic Pharmaceuticals Limited. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Bryant Ranch Prepack 6 Alembic Pharmaceuticals Inc. 5 Alembic Pharmaceuticals Limited 5 Macleods Pharmaceuticals Limited 5 Lannett Company, Inc. 4 Teva Pharmaceuticals USA, Inc. 4 Zydus Lifesciences Limited 4 Zydus Pharmaceuticals USA Inc. 4 AvKARE 3 Aphena Pharma Solutions - Tennessee, LLC 2 Chartwell RX, LLC 1

Vardenafil drug class (RxNorm)

Vardenafil belongs to the Phosphodiesterase 5 Inhibitor class.

Pharmacologic class Phosphodiesterase 5 Inhibitor
Drug family (ATC) Drugs used in erectile dysfunction
How it works Phosphodiesterase 5 Inhibitors

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 Vardenafil 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 Jul 30, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Vardenafil.
📈
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 Vardenafil after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
22
Finished products in the current FDA directory
43
Companies listing them (makers, repackagers, distributors)
11
FDA labeler codes behind them ⓘ
12
Linked representative label ⓘ
Alembic Pharmaceuticals Inc.
Linked label effective
Jul 30, 2025
Composite sections available
23
Linked SPL Set ID
0ce4eb7b-fa50-441d-ae71-eb33dca27926
Linked SPL Document ID
33bb2a69-79e4-49bb-9388-97367b428639
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. Alembic Pharmaceuticals 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 →