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Tadalafil

Tadalafil is a PDE5 inhibitor used to treat erectile dysfunction, benign prostatic hyperplasia (BPH), and pulmonary arterial hypertension (PAH), depending on the product.

Brand names AdcircaCialisAlyqTadliq
Drug class Phosphodiesterase 5 Inhibitor
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 156 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 · 2
Tadalafil 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

Tadalafil is a PDE5 inhibitor that relaxes blood vessels to boost blood flow, used for erectile dysfunction and an enlarged prostate (BPH) as Cialis, and for pulmonary arterial hypertension (high blood pressure in the lungs) as Adcirca, Alyq or Tadliq; on the market since about 2003 and available generically, it is a common first choice for ED. Most people tolerate it well, and the side effects they notice are usually headache, indigestion and back pain. Never take it with nitrates such as nitroglycerin, or with riociguat, because blood pressure can drop dangerously; if chest pain ever hits, tell emergency staff you took tadalafil.

Clinical pearls

  • For ED it only works with sexual stimulation, and one dose lasts longer than sildenafil (Viagra), so timing is less rigid.
  • If you also take an alpha-blocker such as tamsulosin or doxazosin, stand up slowly, since together they lower blood pressure.
  • Avoid grapefruit juice, and remind prescribers of ketoconazole, itraconazole, ritonavir or erythromycin that you take tadalafil, since they raise its levels.
  • Sudden loss of vision or hearing, or an erection lasting more than 4 hours, needs emergency care right away.
How we write & review this content — our editorial policy →
How you get itPrescription only
Comes asTablet, Oral suspension
Earliest FDA record2003
Companies listing it with the FDA50
FDA label last updatedJun 3, 2026
FDA’s strongest warning (boxed)None on the label

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

What Tadalafil is used for

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Tadalafil is approved for several different conditions depending on the specific product:

  • Erectile dysfunction (ED): Cialis and generic tadalafil tablets help men get and maintain erections during sexual activity.
  • Benign prostatic hyperplasia (BPH — enlarged prostate): Cialis and generic tadalafil tablets help relieve urinary symptoms caused by an enlarged prostate.
  • ED and BPH together: Cialis and generic tadalafil tablets can treat both conditions at the same time.
  • Pulmonary arterial hypertension (PAH — high blood pressure in the lungs): Adcirca (tablet), Alyq (tablet), and Tadliq (oral suspension) are approved to improve exercise ability in adults with PAH (WHO Group 1).

How Tadalafil works

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Tadalafil blocks an enzyme called PDE5 (phosphodiesterase type 5). When PDE5 is blocked, a signaling chemical called cGMP stays active longer in the smooth muscle walls of blood vessels. This causes those muscles to relax, widening the blood vessels and increasing blood flow. In the penis, this makes it easier to get an erection — but only when sexual stimulation is present, because that's what kicks off the process. In the lungs, widening the blood vessels reduces resistance and the strain on the heart, which is what helps people with PAH exercise more easily. The exact reason it helps BPH symptoms hasn't been fully worked out, but the same PDE5 enzyme is found in the prostate and bladder.

Tadalafil dosage

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How you take tadalafil depends entirely on which condition is being treated and which product is prescribed. Tablets can be taken with or without food. Tadalafil for ED can be taken as needed (before sexual activity) or as a once-daily tablet. For BPH, or for both ED and BPH, it is typically taken once daily at around the same time each day. Adcirca and Alyq (both tablets for PAH) are taken once daily — the full daily dose should not be split up over the day. Tadliq oral suspension (for PAH) is also taken once daily by mouth. Always follow your prescriber's specific instructions, and do not split Cialis tablets.

Dosing details from the FDA-approved label

From the Tadalafil 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.

  • Erectile dysfunction (ED) - Cialis for use as needed
    • Starting dose 10 mg taken prior to anticipated sexual activity
    • May be increased to 20 mg or decreased to 5 mg based on individual efficacy and tolerability
    • Maximum: Once per day in most patients
    • Improves erectile function compared to placebo up to 36 hours following dosing; may be taken without regard to food; do not split tablets
  • Erectile dysfunction (ED) - Cialis for once daily use
    • 2.5 mg taken at approximately the same time every day, without regard to timing of sexual activity
    • May be increased to 5 mg based on individual efficacy and tolerability
    • May be taken without regard to food
  • Benign prostatic hyperplasia (BPH) - Cialis for once daily use
    • 5 mg taken at approximately the same time every day
    • When therapy is initiated with Cialis and finasteride, 5 mg once daily for up to 26 weeks
    • May be taken without regard to food
  • ED and BPH - Cialis for once daily use
    • 5 mg taken at approximately the same time every day, without regard to timing of sexual activity
    • May be taken without regard to food
  • Renal impairment, creatinine clearance 30 to 50 mL/min - Cialis for use as needed
    • Starting dose of 5 mg not more than once per day
    • Maximum: 10 mg not more than once in every 48 hours
    • Kidney adjustment
  • Renal impairment, creatinine clearance less than 30 mL/min or on hemodialysis - Cialis for use as needed
    • Maximum dose is 5 mg not more than once in every 72 hours
    • Maximum: 5 mg not more than once in every 72 hours
    • Once daily use for ED is not recommended in this group
  • Renal impairment, creatinine clearance 30 to 50 mL/min - once daily use for BPH and ED/BPH
    • Starting dose of 2.5 mg
    • An increase to 5 mg may be considered based on individual response
    • Once daily use not recommended if creatinine clearance less than 30 mL/min or on hemodialysis
  • Mild or moderate hepatic impairment (Child Pugh Class A or B) - Cialis for use as needed
    • Dose should not exceed 10 mg once per day
    • Maximum: 10 mg once per day
    • Once daily use not extensively evaluated, caution advised; not recommended in severe (Child Pugh Class C)
  • Pulmonary arterial hypertension (PAH) - Adcirca
    • 40 mg (two 20 mg tablets) taken once daily with or without food
    • Dividing the 40 mg dose over the course of the day is not recommended; use with ritonavir requires dosage adjustments
  • Adcirca mild (creatinine clearance 51 to 80 mL/min) or moderate (31 to 50 mL/min) renal impairment
    • Start at 20 mg once daily
    • Increase to 40 mg once daily based on individual tolerability
    • Renal impairment adjustment
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION Do not split tadalafil tablets; entire dose should be taken. • Tadalafil tablets for use as needed: • ED: Starting dose: 10 mg as needed prior to sexual activity. Increase to 20 mg or decrease to 5 mg based upon efficacy/tolerability. Improves erectile function compared to placebo up to 36 hours post dose. Not to be taken more than once per day ( 2.1 ). • Tadalafil tablets for once daily use: • ED: 2.5 mg taken once daily, without regard to timing of sexual activity. May increase to 5 mg based upon efficacy and tolerability ( 2.2 ). • BPH: 5 mg, taken at approximately the same time every day ( 2.3 ). • ED and BPH: 5 mg, taken at approximately the same time every day ( 2.3 , 2.4 ). • Tadalafil tablets may be taken without regard to food ( 2.5 ). 2.1 Tadalafil Tablets for Use as Needed for Erectile Dysfunction • The recommended starting dose of tadalafil tablets for use as needed in most patients is 10 mg, taken prior to anticipated sexual activity. • The dose may be increased to 20 mg or decreased to 5 mg, based on individual efficacy and tolerability. The maximum recommended dosing frequency is once per day in most patients. • Tadalafil tablets for use as needed were shown to improve erectile function compared to placebo up to 36 hours following dosing. Therefore, when advising patients on optimal use of tadalafil tablets, this should be taken into consideration. 2.2 Tadalafil Tablets for Once Daily Use for Erectile Dysfunction • The recommended starting dose of tadalafil tablets for once daily use is 2.5 mg, taken at approximately the same time every day, without regard to timing of sexual activity. • The tadalafil tablet dose for once daily use may be increased to 5 mg, based on individual efficacy and tolerability. 2.3 Tadalafil Tablets for Once Daily Use for Benign Prostatic Hyperplasia • The recommended dose of tadalafil tablets for once daily use is 5 mg, taken at approximately the same time every day. • When therapy for BPH is initiated with tadalafil tablets and finasteride, the recommended dose of tadalafil tablets for once daily use is 5 mg, taken at approximately the same time every day for up to 26 weeks.

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

Tadalafil side effects

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The most commonly reported side effects include:

Common side effects

  • Headache
  • Indigestion (dyspepsia)
  • Back pain
  • Muscle aches (myalgia)
  • Stuffy or runny nose (nasal congestion)
  • Flushing (warmth or redness in the face)
  • Pain in arms or legs

When to get medical help

  • Get emergency help immediately if you have chest pain — do NOT take a nitrate (like nitroglycerin) without telling emergency staff you took tadalafil.
  • Seek emergency care if an erection lasts more than 4 hours (priapism — this can cause permanent damage).
  • Stop taking tadalafil and call a doctor right away if you have a sudden loss of vision in one or both eyes.
  • Stop and seek prompt medical attention if you experience a sudden decrease or complete loss of hearing.
  • Call a doctor if you feel dizzy or faint, especially when standing up, as tadalafil can lower blood pressure.

Tadalafil warnings and precautions

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  • Nitrates are absolutely off-limits: Taking tadalafil with any nitrate medication (such as nitroglycerin or isosorbide) can cause a severe, life-threatening drop in blood pressure. If you need nitroglycerin in an emergency, at least 48 hours must pass after your last tadalafil dose before it can be given.
  • Riociguat and GC stimulators: Do not take tadalafil with riociguat or similar drugs — this combination also poses a serious blood pressure risk.
  • Heart health: Sexual activity itself puts stress on the heart. Tadalafil is not recommended if your doctor has told you sex is inadvisable due to your heart condition. It is also not recommended within 90 days of a heart attack, or in people with unstable angina or significant heart failure.
  • Priapism: A prolonged, painful erection lasting more than 4 hours is a medical emergency — seek care immediately to prevent permanent damage.
  • Vision and hearing: Rare cases of sudden vision loss (possibly NAION — reduced blood flow to the optic nerve) and sudden hearing loss have been reported. Stop tadalafil and seek care immediately if either occurs.
  • Blood pressure interactions: Alpha-blockers, blood pressure medications, and large amounts of alcohol (5 or more drinks) can amplify tadalafil's blood pressure–lowering effect, leading to dizziness or fainting.

Tadalafil interactions

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Tadalafil interacts with several important drugs and substances:

  • Nitrates (nitroglycerin, isosorbide) — contraindicated; causes dangerous blood pressure drops.
  • Riociguat and guanylate cyclase stimulators — contraindicated; similar blood pressure risk.
  • Alpha-blockers (doxazosin, tamsulosin, alfuzosin) — additive blood pressure–lowering effect; use with caution.
  • Blood pressure medications (amlodipine, enalapril, metoprolol, others) — may further reduce blood pressure.
  • Strong CYP3A4 inhibitors (ketoconazole, itraconazole, ritonavir, erythromycin, grapefruit juice) — increase tadalafil levels in the blood, which may require a lower dose.
  • CYP3A4 inducers (rifampin, carbamazepine, phenytoin, phenobarbital) — can significantly reduce tadalafil levels and effectiveness.
  • Alcohol (5 or more drinks) — increases risk of dizziness, fast heart rate, and low blood pressure.

Interactions listed in the FDA-approved label

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

  • Nitrates: Tadalafil potentiates the hypotensive effect of nitrates; use with any form of organic nitrate is contraindicated. If nitrate is medically necessary in a life-threatening situation, at least 48 hours should elapse after the last tadalafil dose, with close medical supervision and hemodynamic monitoring.
  • Alpha-blockers: Both are vasodilators with blood-pressure-lowering effects, so an additive effect on blood pressure may be anticipated. Caution is advised. For ED, patients should be stable on alpha-blocker therapy and Cialis started at the lowest recommended dose; Cialis is not recommended with alpha-blockers for BPH.
  • Antihypertensives: Small reductions in blood pressure occurred when tadalafil was given with amlodipine, angiotensin II receptor blockers, bendrofluazide, enalapril and metoprolol compared with placebo.
  • Alcohol: Both are mild vasodilators; substantial alcohol consumption (e.g., 5 units or greater) with tadalafil can increase orthostatic signs and symptoms including increased heart rate, decreased standing blood pressure, dizziness and headache.
  • CYP3A4 inhibitors (e.g., ketoconazole, ritonavir): They increase tadalafil exposure; ketoconazole 400 mg daily increased tadalafil 20 mg AUC by 312% and Cmax by 22%. For use as needed: no more than 10 mg every 72 hours. For once daily use: dose not to exceed 2.5 mg.
  • Other CYP3A4 inhibitors (erythromycin, itraconazole, grapefruit juice) and other HIV protease inhibitors: Would likely increase tadalafil exposure, although specific interactions have not been studied.
  • CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, phenobarbital): They decrease tadalafil exposure; rifampin 600 mg daily reduced tadalafil 10 mg AUC by 88% and Cmax by 46%, and may decrease efficacy of once daily use by an unknown amount. No dose adjustment is warranted.
  • Antacids (magnesium hydroxide/aluminum hydroxide): Reduced the apparent rate of absorption of tadalafil without altering exposure (AUC).
  • H2 antagonists (e.g., nizatidine): Increase in gastric pH from nizatidine had no significant effect on pharmacokinetics.
  • Aspirin: Tadalafil did not potentiate the increase in bleeding time caused by aspirin.
Read the label’s full interactions text

7 DRUG INTERACTIONS • Tadalafil can potentiate the hypotensive effects of nitrates, alpha-blockers, antihypertensives or alcohol ( 7.1 ). • CYP3A4 inhibitors (e.g. ketoconazole, ritonavir) increase tadalafil exposure ( 2.7 , 5.10 , 7.2 ) requiring dose adjustment: • Tadalafil tablets for use as needed: no more than 10 mg every 72 hours. • Tadalafil tablets for once daily use: dose not to exceed 2.5 mg. • CYP3A4 inducers (e.g. rifampin) decrease tadalafil exposure ( 7.2 ). 7.1 Potential for Pharmacodynamic Interactions with Tadalafil Tablets Nitrates — Administration of tadalafil tablets to patients who are using any form of organic nitrate, is contraindicated. In clinical pharmacology studies, tadalafil was shown to potentiate the hypotensive effect of nitrates. In a patient who has taken tadalafil, where nitrate administration is deemed medically necessary in a life-threatening situation, at least 48 hours should elapse after the last dose of tadalafil before nitrate administration is considered. In such circumstances, nitrates should still only be administered under close medical supervision with appropriate hemodynamic monitoring [see Dosage and Administration ( 2.7 ), Contraindications ( 4.1 ), and Clinical Pharmacology ( 12.2 )] . Alpha-Blockers — Caution is advised when PDE5 inhibitors are coadministered with alpha-blockers. PDE5 inhibitors, including tadalafil 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 coadministration of tadalafil with doxazosin, tamsulosin or alfuzosin. [see Dosage and Administration ( 2.7 ), Warnings and Precautions ( 5.6 ), and Clinical Pharmacology ( 12.2 )] . Antihypertensives — PDE5 inhibitors, including tadalafil are mild systemic vasodilators.

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 Tadalafil interactions, ranked by severity Check Tadalafil against a supplement or herb →

Before taking Tadalafil

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  • Do not take tadalafil if you use any form of nitrate (for chest pain) or riociguat — this combination is contraindicated.
  • Do not take tadalafil if you have had a serious allergic reaction to tadalafil or Adcirca in the past.
  • Tell your doctor if you have heart disease, a recent heart attack (within the past 90 days), unstable angina, uncontrolled high or low blood pressure, or serious heart failure.
  • Tell your doctor if you have liver disease — severe liver impairment makes tadalafil not recommended; mild or moderate liver disease requires caution.
  • Tell your doctor if you have kidney disease or are on dialysis, as dosing restrictions may apply.
  • Tell your doctor if you have ever had sudden vision or hearing loss, a retinal disorder, or a condition affecting the shape of the optic nerve.
  • Tell your doctor about all other medications you take, especially alpha-blockers or blood pressure drugs.
  • Tadalafil tablets are not approved for use in women or children under 18 years of age.
  • Older adults may be more sensitive to tadalafil's effects; no automatic dose change is needed, but greater sensitivity should be kept in mind.
  • Some studies found a decrease in sperm concentration with tadalafil; discuss with your doctor if fertility is a concern.

Tadalafil overdose

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In studies, single doses far above the normal therapeutic range were given to healthy volunteers and side effects were similar to those seen at regular doses. If you take too much, standard supportive care is the approach — there is no specific antidote. Dialysis does not meaningfully remove tadalafil from the body. Contact Poison Control or seek emergency care if you suspect an overdose.

What Tadalafil does in the body

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Tadalafil causes blood vessels to relax and widen by preventing the breakdown of cGMP, a chemical that signals smooth muscle to relax. At usual doses in healthy volunteers, it produced only minimal changes in resting blood pressure on its own. However, when combined with nitrates, it significantly amplifies blood pressure–lowering effects — which is why that combination is contraindicated. When taken with alpha-blockers or large amounts of alcohol, a further additive blood pressure reduction can occur, sometimes enough to cause dizziness or fainting when standing up.

How your body processes Tadalafil

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After a tadalafil tablet is swallowed, peak blood levels are typically reached within 30 minutes to 6 hours. Food does not affect how much of the drug is absorbed, so it can be taken with or without a meal. Tadalafil is broken down mainly by the liver enzyme CYP3A4 and is eliminated mostly through the feces (about 61%) and urine (about 36%). Its half-life (the time it takes for the body to clear half the drug) is about 17.5 hours — notably longer than other PDE5 inhibitors — which is why its effects can last up to 36 hours. People with kidney or liver impairment, and older adults, may have higher drug levels in their system and may need dose adjustments.

How to store Tadalafil

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Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) . Keep out of reach of children.

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

144

Supplements & herbs that interact with Tadalafil

144 supplements and herbal products have documented interactions with Tadalafil 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 Tadalafil — ranked by severity The full interaction hub: 5 major · 98 moderate · 41 minor · every one linked to its full report. Check Tadalafil 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.

Tadalafil: pharmacist answers to common questions

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

What exactly is tadalafil used for, and why do I see so many different brand names?

▾
Tadalafil is the active ingredient in several branded products, each approved for a specific use. Cialis (and generic tadalafil tablets) treat erectile dysfunction, an enlarged prostate (BPH), or both. Adcirca, Alyq, and Tadliq are approved specifically for pulmonary arterial hypertension — high blood pressure in the lungs — to help people exercise more easily. The same ingredient, but different approved uses depending on the product you've been prescribed.

Do I take it every day, or just when I need it?

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It depends on what you're taking it for. For erectile dysfunction, your doctor may prescribe it as-needed — taken before sexual activity — or as a lower once-daily dose so you don't have to plan ahead. For BPH or both ED and BPH together, it's taken once daily at about the same time each day. For PAH (Adcirca, Alyq, or Tadliq), it's also once daily. Whatever you've been prescribed, stick to that schedule and don't take it more than once a day.

What side effects should I expect, and which ones mean I need to call a doctor?

▾
The most common ones are headache, indigestion, back pain, muscle aches, stuffy nose, and flushing — usually mild and manageable. You need immediate medical attention for three things: an erection lasting more than 4 hours (go to the ER — this can cause permanent damage), sudden loss of vision in one or both eyes, or a sudden drop in your hearing. If you have chest pain after taking tadalafil and feel you need nitroglycerin, call 911 and tell them you took tadalafil — timing matters.

I've heard you can't take it with certain heart medications. What do I need to avoid?

▾
The big one is nitrates — drugs like nitroglycerin, isosorbide mononitrate, or isosorbide dinitrate used for chest pain or angina. Combining them with tadalafil can cause a severe, potentially life-threatening drop in blood pressure. This combination is absolutely contraindicated. You also cannot take it with riociguat. Be cautious with alpha-blockers, blood pressure medications, and alcohol — these can all lower your blood pressure further when combined with tadalafil. Always give your doctor and pharmacist a full list of everything you take.

Does it work automatically, or do I need to be in the mood?

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For erectile dysfunction, tadalafil only works when you're sexually stimulated — it doesn't cause an erection on its own. Sexual arousal is what triggers the natural process that tadalafil then enhances. For PAH, it works continuously to relax the blood vessels in the lungs, so that one doesn't require any trigger.

I'm older and have some kidney issues — is tadalafil safe for me?

▾
Possibly, but it depends on how well your kidneys are working. Tadalafil stays in your body longer and reaches higher levels when kidney function is reduced, so your doctor may need to adjust the dose or schedule, or avoid certain formulations altogether. Dialysis doesn't clear tadalafil from the body well. Older adults in general don't automatically need a different dose, but may be more sensitive to the drug's effects. Make sure your prescriber knows your kidney status before starting.

Is Tadalafil available over the counter?

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No. Tadalafil is a prescription medicine: every Tadalafil 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 Tadalafil first available?

▾
The earliest FDA record we hold for Tadalafil 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 Tadalafil was first used.

Who makes Tadalafil?

▾
50 companies currently list Tadalafil products in the FDA's NDC Directory, including NuCare Pharmaceuticals,Inc., Asclemed USA, Inc., Bryant Ranch Prepack. 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 Tadalafil on HelloPharmacist

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

Tadalafil forms and strengths (how it comes)

Tadalafil 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
Brands Adcirca Alyq Cialis
How this form is used
What it may be used for
  • Cialis (and generic tadalafil tablets) are used to treat erectile dysfunction (ED).
  • Cialis (and generic tadalafil tablets) are used to treat the signs and symptoms of benign prostatic hyperplasia (BPH).
  • Cialis (and generic tadalafil tablets) are used to treat both ED and BPH together.
  • Adcirca and Alyq are used to treat pulmonary arterial hypertension (PAH, WHO Group 1) to improve exercise ability.
Important instructions
  • Cialis tablets should not be split — take the entire dose.
  • Cialis tablets for ED may be taken as needed before sexual activity or once daily; for BPH or ED/BPH, take once daily at approximately the same time each day.
  • Adcirca is taken once daily — do not divide the daily dose across multiple times during the day.
  • All tadalafil tablets can be taken with or without food.
Available strengths 4 strengths
2.5 mg 5 mg 10 mg 20 mg
456 FDA-listed product records ⓘ

Oral suspension

By mouth
Brands Tadliq
How this form is used
What it may be used for
  • Tadliq is used to treat pulmonary arterial hypertension (PAH, WHO Group 1) to improve exercise ability.
Important instructions
  • Tadliq is taken by mouth once daily.
  • Take Tadliq with or without food, as directed by your prescriber.
  • Follow your prescriber's instructions carefully for the correct dose and schedule.
Available strengths 1 strength
20 mg/5 mL
3 FDA-listed product records ⓘ

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

How Tadalafil 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.

50 companies list 254 Tadalafil product records with the FDA, mostly as tablet, oral suspension; the earliest marketing or approval year on record is 2003. Brand names on the directory include Adcirca, Cialis, Alyq and 1 more; the rest are generics.

2
Dose forms ⓘ
50
Labelers (makers, repackagers, distributors)
5
Brand names
254
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 (37) · Granule (1) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

NuCare Pharmaceuticals,Inc.7%
Asclemed USA, Inc.6%
Bryant Ranch Prepack6%
Proficient Rx LP5%
A-S Medication Solutions4%
Aphena Pharma Solutions - Tennessee, LLC4%
Other makers69%

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

How widely Tadalafil is used (Medicaid data)

A general measure of how commonly Tadalafil 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 Tadalafil 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.

53,237
Medicaid prescriptions filled (Q1–Q4 2025)
$21.9M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Tadalafil prescribed? Of the 1,601 medications we measure, Tadalafil ranks #622 by Medicaid prescriptions — more than 61% of them.

Where Tadalafil ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #622 of 1,601
#617 Abatacept Injection 55,268 Rx #618 Fluticasone Topical 55,053 Rx #619 Darunavir, Cobicistat,... 54,928 Rx #620 Entecavir 54,796 Rx #621 Ivacaftor 53,353 Rx #622 Tadalafil 53,237 Rx #623 Cefepime Injection 52,968 Rx #624 Sulindac 52,720 Rx #625 Leucovorin Injection 52,618 Rx #626 Cefprozil 52,006 Rx #627 Mometasone Nasal Spray 51,854 Rx

Utilization by Tadalafil 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 20 mg oral tablet is the most-dispensed Tadalafil product — about 46% of these Medicaid prescriptions.

Pulmonary Hypertension tadalafil 20 MG Oral Tablet Most dispensed

24,556 Medicaid prescriptions (Q1–Q4 2025) 46% of Tadalafil prescriptions shown $10.3M gross reimbursement (before rebates) ≈ $420 per prescription (gross)

Summed across the 10 of 31 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2123194

tadalafil 5 MG Oral Tablet

17,184 Medicaid prescriptions (Q1–Q4 2025) 32% of Tadalafil prescriptions shown $227,750 gross reimbursement (before rebates) ≈ $13 per prescription (gross)

Summed across the 15 of 231 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 403957

tadalafil 4 MG/ML Oral Suspension

6,799 Medicaid prescriptions (Q1–Q4 2025) 13% of Tadalafil prescriptions shown $11.2M gross reimbursement (before rebates) ≈ $1,654 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2613563

tadalafil 20 MG Oral Tablet

2,929 Medicaid prescriptions (Q1–Q4 2025) 6% of Tadalafil prescriptions shown $42,617 gross reimbursement (before rebates) ≈ $15 per prescription (gross)

Summed across the 12 of 251 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 402019

tadalafil 10 MG Oral Tablet

1,745 Medicaid prescriptions (Q1–Q4 2025) 3% of Tadalafil prescriptions shown $20,155 gross reimbursement (before rebates) ≈ $12 per prescription (gross)

Summed across the 11 of 168 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 484814

tadalafil 2.5 MG Oral Tablet

24 Medicaid prescriptions (Q1–Q4 2025) <1% of Tadalafil prescriptions shown $360 gross reimbursement (before rebates) ≈ $15 per prescription (gross)

Summed across the 2 of 121 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 757707

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 Tadalafil, 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 51 of 803 listed Tadalafil NDCs with Medicaid activity.

Compare Tadalafil products

A representative set of FDA-listed product records for Tadalafil — 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 107 of 254 products — FDA National Drug Code Directory. See every product, package size and price: browse all 254 Tadalafil NDCs →

Tadalafil 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 4 Tadalafil recalls since July 2021, covering 9 product listings. Two of them are still ongoing or began in the last six months and are listed first. 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 Mar 23, 2023 · Preferred Pharmaceuticals, Inc.
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
  • Tadalafil Tablets, USP, 20 mg, 7-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC 68788-8153-7 Lots: Lot: C0822E, Exp 1/31/2024, F1121B, Exp 1/31/2024, G2721L, Exp 1/31/2024. FDA record D-0526-2023 →
Ongoing Class II Mar 16, 2023 · Northwind Pharmaceuticals LLC
CGMP Deviations
  • Tadalafil Tablets, USP 5 mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203. NDC 51655-487-52 Lots: Lot #: F114302001, Exp. Date 05/31/2023 FDA record D-0554-2023 →
  • Tadalafil Tablets, USP 20 mg, packaged in a) 6-count bottles (NDC 51655-473-87), and b) 15-count bottles (NDC 51655-473-54), Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203. Lots: a) Lot #: F113892002, Exp. Date 08/31/2023; F113892201, Exp. Date 11/30/2023 b) Lot #: F113892001, Exp. Date 08/31/2023; F113892202, Exp. Date 11/30/2023; F113892203, Exp. Date 12/31/2023 FDA record D-0553-2023 →
Class II Feb 7, 2023 · Terminated · Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
  • Tadalafil Tablets, USP, 20 mg, Rx Only, Packaged as: a) 30-count bottle NDC 16729-372-10, UPC 3 16729 37210 7; b) 500-count bottle NDC 16729-372-16, UPC 3 16729 37216 9; Manufactured for: Accord Heal… Lots: Batches: a) P2002461, Exp. Date 4/30/2023; P2002457, Exp. Date 4/30/2023; P2002460, Exp. Date 4/30/2023; P2002464, Exp. Date 4/30/2023; P2002463, Exp. Date 4/30/2023; P2002462, Exp. Date 4/30/2023; P2002465, Exp. Date 4/30/2023; P2003153,… FDA record D-0417-2023 →
  • Tadalafil Tablets, USP 10 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-371-10, UPC 3 16729 37110 0; b) 500-count bottle NDC 16729-371-16, UPC 3 16729 37116 2; Manufactured for: Accord Health… Lots: Batches: a) P2002525, Exp. Date 4/30/2023; P2004442, Exp. Date 7/31/2023; P2005014, Exp. Date 8/31/2023; P2005015, Exp. Date 8/31/2023; P2005016, Exp. Date 8/31/2023; P2005825, Exp. Date 10/31/2023; P2005824, Exp. Date 10/31/2023; P2005826… FDA record D-0416-2023 →
  • Tadalafil Tablets, USP, 5 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-370-10, UPC 3 16729 37010 3; b) 500-count bottle NDC 16729-370-16, UPC 3 16729 37016 5; Manufactured for: Accord Health… Lots: Batches: a) P2002450, Exp. Date 4/30/2023, P2003222, Exp. Date 5/31/2023; P2003223, Exp. Date 5/31/2023; P2003224, Exp. Date 5/31/2023; P2004636, Exp. Date 8/31/2023; P2005035, Exp. Date 8/31/2023; P2005038, Exp. Date 8/31/2023; P2005040,… FDA record D-0415-2023 →
  • Tadalafil Tablets, USP, 2.5 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-369-10, UPC 3 16729 36910 7; b) 500-count bottle NDC 16729-369-16, UPC 3 16729 36916 9; Manufactured for: Accord Heal… Lots: Batches: a) P2002522, Exp. Date 4/30/2023; P2005817, P2005816, Exp. Date 10/31/2023; P2203687, Exp. Date 6/30/2025; b) P2002521, Exp. Date 4/30/2023; P2005818, Exp. Date 10/31/2023; P2100075, Exp. Date 12/31/2023; P2100996, P2100997, P2100… FDA record D-0414-2023 →
Class II Oct 25, 2021 · Terminated · SUN PHARMACEUTICAL INDUSTRIES INC
Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.
  • Tadalafil Tablets, USP 20 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Limited, India, NDC # 16714-077-01 Lots: Lot # DNC0814A, DNC0815A, Exp. Date 04/2023 FDA record D-0231-2022 →
  • Tadalafil Tablets, USP 5 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Limited, India, NDC # 16714-075-01 Lots: Lot # DNC1127A, exp. date 05/2023 FDA record D-0230-2022 →

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) Tadalafil RxCUI 358263 2 dose forms · 6 strengths
  1. Dose form (SCDF) Oral Suspension RxCUI 2613562 In current FDA listings
    Clinical drug / strength (SCD) 4 MG/ML RxCUI 2613563

Look up RxCUI 358263 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 Tadalafil 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 $53.83 per tablet NDC details & price history
Tablet, Film Coated · Oral 5 mg $9.20 per tablet NDC details & price history
Tablet, Film Coated · Oral 10 mg $53.69 per tablet NDC details & price history
Tablet, Film Coated · Oral 2.5 mg $0.113 per tablet NDC details & price history
Tablet · Oral 20 mg $0.167 per tablet NDC details & price history
Tablet · Oral 5 mg $0.103 per tablet NDC details & price history
Tablet · Oral 10 mg $0.153 per tablet NDC details & price history
Tablet · Oral 2.5 mg $0.113 per tablet NDC details & price history
Tablet, Film Coated 5 mg $0.146 per tablet NDC details & price history
Tablet, Film Coated 2.5 mg $0.219 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.

Tadalafil brand names

Tadalafil is sold under 4 brand names in the FDA directory — Adcirca, Cialis, Alyq, Tadliq. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Adcirca Cialis Alyq Tadliq

Who makes Tadalafil: manufacturers and labelers

50 companies list Tadalafil products with the FDA. By number of product records, the largest are NuCare Pharmaceuticals,Inc., Asclemed USA, Inc., Bryant Ranch Prepack. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

NuCare Pharmaceuticals,Inc. 17 Asclemed USA, Inc. 15 Bryant Ranch Prepack 15 Proficient Rx LP 13 A-S Medication Solutions 11 Aphena Pharma Solutions - Tennessee, LLC 9 Solco Healthcare US, LLC 9 Amneal Pharmaceuticals NY LLC 8 NorthStar Rx, LLC 8 PD-Rx Pharmaceuticals, Inc. 7 Preferred Pharmaceuticals Inc. 7 Remedyrepack Inc. 6 Ajanta Pharma USA Inc. 5 Aurobindo Pharma Limited 5 AvKARE 5 Camber Pharmaceuticals, Inc. 5 Dr.Reddys Laboratories Inc 5 Macleods Pharmaceuticals Limited 5 Torrent Pharmaceuticals Limited 5 Accord Healthcare Inc. 4 Alembic Pharmaceuticals Inc. 4 Alembic Pharmaceuticals Limited 4 Bostal LLC 4 Burel Pharmaceuticals, LLC 4

…and 26 more on the FDA NDC directory.

Tadalafil drug class (RxNorm)

Tadalafil belongs to the Phosphodiesterase 5 Inhibitor class.

Pharmacologic class Phosphodiesterase 5 Inhibitor
Drug family (ATC) Testosterone-5-alpha reductase inhibitors, Antihypertensives for pulmonary arterial hypertension, 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 Tadalafil 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 Jun 3, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Tadalafil.
📈
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 Tadalafil after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
156
Finished products in the current FDA directory
254
Companies listing them (makers, repackagers, distributors)
50
FDA labeler codes behind them ⓘ
55
Linked representative label ⓘ
Eli Lilly and Company
Linked label effective
Jun 3, 2026
Composite sections available
23
Linked SPL Set ID
bcd8f8ab-81a2-4891-83db-24a0b0e25895
Linked SPL Document ID
2b22fb0c-f97a-4008-a83b-1695396ef11d
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. Eli Lilly and Company 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 →