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Prescription oral tableta phosphodiesterase 5 (PDE5) inhibitor, which is a medicine that blocks an enzyme called PDE5

Tadalafil

Tadalafil · Say it: ta-DAL-a-fil

A prescription tablet taken by mouth to treat erectile dysfunction and/or the signs and symptoms of an enlarged prostate (benign prostatic hyperplasia).

Reading levelLanguage

Used for

Erectile dysfunction (ED)

Comes as

2.5 mg tablets (off white to pale yellow, almond shaped, film coated); 5 mg tablets (light yellow, almond shaped, film coated)

Common side effects

Headache, Indigestion (dyspepsia), Back pain

Key facts
Generic nameTadalafil
Brand names—
Type of medicinea phosphodiesterase 5 (PDE5) inhibitor, which is a medicine that blocks an enzyme called PDE5
How it is soldPrescription oral tablet
Comes as2.5 mg tablets (off white to pale yellow, almond shaped, film coated); 5 mg tablets (light yellow, almond shaped, film coated); 10 mg tablets (yellow, almond shaped, film coated); 20 mg tablets (yellow, almond shaped, film coated)
Routeoral
Boxed warningNo
Label date2026-06-24

💊 What is Tadalafil used for?

  • Erectile dysfunction (ED)
  • Signs and symptoms of benign prostatic hyperplasia (BPH), a condition where the prostate gland is enlarged and not cancer
  • Both ED and BPH at the same time
  • When used with finasteride to start BPH treatment, the label recommends this use for up to 26 weeks, because the extra benefit of tadalafil decreases from 4 weeks until 26 weeks and its benefit beyond 26 weeks is unknown

How it works

The label describes tadalafil as a selective inhibitor of cGMP-specific phosphodiesterase type 5 (PDE5), an enzyme. The label does not explain this process in more detail.

How it is usually taken

  • The label says do not split the tablets. The entire dose should be taken.
  • For use as needed for ED, the label says the tablet is taken before anticipated sexual activity, and it should not be taken more than once per day.
  • For once-daily use (for ED, BPH, or both), the label says the tablet is taken at approximately the same time every day.
  • For once-daily ED use, the label says it can be taken without regard to the timing of sexual activity.
  • The label says tadalafil may be taken with or without food.
  • Follow the instructions from your prescriber or pharmacist about which form and schedule applies to you.

Comes as

  • 2.5 mg tablets (off white to pale yellow, almond shaped, film coated)
  • 5 mg tablets (light yellow, almond shaped, film coated)
  • 10 mg tablets (yellow, almond shaped, film coated)
  • 20 mg tablets (yellow, almond shaped, film coated)

⚠️ Tadalafil side effects

Common side effects

  • Headache
  • Indigestion (dyspepsia)
  • Back pain
  • Muscle pain (myalgia)
  • Nasal congestion
  • Flushing (warmth or redness of the face)
  • Pain in the limbs
  • In the once-daily ED studies, also nasopharyngitis (a throat and nose infection) and upper respiratory tract infection

Get medical help right away if

  • Get medical help right away if you have chest pain (angina) after taking tadalafil. The label says to seek immediate medical attention.
  • Get medical help right away if you have chest pain or other symptoms when you start sexual activity. The label says to stop further sexual activity and seek immediate medical attention.
  • Get emergency medical attention if an erection lasts longer than 4 hours, whether it is painful or not. The label says prolonged erections can cause permanent damage if not treated promptly.
  • Stop taking tadalafil and get medical attention right away if you have a sudden loss of vision in one or both eyes. The label says this may be a sign of a rare eye condition called NAION that can cause permanent vision loss.
  • Stop taking tadalafil and get prompt medical attention if you have a sudden decrease or loss of hearing. The label says this may come with ringing in the ears (tinnitus) and dizziness.
  • If you take it with nitrates, the label warns that blood pressure can suddenly drop to an unsafe level, causing dizziness, fainting, or even heart attack or stroke.

🛑 Who should not take Tadalafil, and who should be careful

The label says not to take it if

  • You use any form of organic nitrate, either regularly or as needed. The label says this combination is contraindicated.
  • You use a guanylate cyclase (GC) stimulator, such as riociguat. The label says this combination should not be used.
  • You have a known serious allergic reaction (hypersensitivity) to tadalafil or to ADCIRCA. The label lists reactions such as Stevens-Johnson syndrome and exfoliative dermatitis.

Tell your doctor before taking it if

  • Tell your prescriber about your heart and blood vessel health. The label says there is a degree of cardiac risk with sexual activity, and tadalafil should not be used when sexual activity is inadvisable because of your cardiovascular status.
  • The label says tadalafil is not recommended for people who have had a heart attack within the last 90 days, unstable angina or angina during sexual intercourse, New York Heart Association Class 2 or greater heart failure in the last 6 months, uncontrolled irregular heartbeat, low blood pressure (less than 90/50 mm Hg), uncontrolled high blood pressure, or a stroke within the last 6 months.
  • Tell your prescriber if you have had NAION (a sudden vision loss condition) in one eye, or a 'crowded' optic disc. The label says these may increase the risk of NAION.
  • Tell your prescriber if you have a condition that makes you prone to priapism (prolonged erection), or left ventricular outflow obstruction such as aortic stenosis. The label says caution is advised.
  • Tell your prescriber if you take alpha-blockers or other blood pressure medicines. The label says tadalafil can add to their blood pressure lowering effects.
  • The label says that for BPH, other urological conditions with similar symptoms should be considered first.
  • The label says tadalafil offers no protection against sexually transmitted diseases, including HIV.

🔀 Tadalafil with other medicines, food and alcohol

The label says to discuss these with your doctor or pharmacist

  • Nitrates: The label says tadalafil is contraindicated with any organic nitrate. If nitrates are medically necessary in a life-threatening situation, the label says at least 48 hours should pass after the last tadalafil dose, and nitrates should only be given under close medical supervision.
  • Alpha-blockers (such as doxazosin, tamsulosin, or alfuzosin): The label says caution is advised, because both can lower blood pressure.
  • Blood pressure medicines (such as amlodipine, angiotensin II receptor blockers, bendrofluazide, enalapril, and metoprolol): The label says small blood pressure reductions occurred when these were combined with tadalafil.
  • CYP3A4 inhibitors (such as ketoconazole and ritonavir): The label says these increase tadalafil levels and require dose limits.
  • CYP3A4 inducers (such as rifampin): The label says these decrease tadalafil levels.
  • GC stimulators (such as riociguat): Contraindicated, as noted above.
  • Alcohol: The label says substantial alcohol use can increase dizziness, headache, and drops in standing blood pressure.

Alcohol and food

The label says tadalafil may be taken without regard to food. The label also says that substantial alcohol use (5 units or greater) with tadalafil can increase dizziness, headache, and drops in standing blood pressure.

🤰 Tadalafil in pregnancy and breastfeeding

Pregnancy

The label says tadalafil is not indicated for use in females. It also says there are no data on use in pregnant women. In animal studies, no harmful developmental effects were seen at high exposures, but the label notes some effects on pup survival at very high doses.

Breastfeeding

The label does not say.

🗓️ Storage, missed doses and taking too much

Storage

The label says to store at 25°C (77°F), with excursions permitted between 15°C and 30°C (59°F and 86°F). Keep out of reach of children.

If a dose is missed

The label does not say.

If too much is taken

The label says single doses much higher than recommended have been given to healthy study volunteers, and that adverse events were similar to those seen at lower doses. The label says standard supportive measures should be used as needed. It also says hemodialysis contributes negligibly to tadalafil removal from the body.

🗒️ Questions to ask about Tadalafil

🎯 Check what you understood

1. According to the label, how should tadalafil tablets be handled?

2. What does the label say about combining tadalafil with organic nitrates?

3. What does the label say about an erection that lasts a long time?

❓ Tadalafil: frequently asked questions

Can I take tadalafil with food?

The label says tadalafil tablets may be taken without regard to food. It does not require a meal.

Does tadalafil protect against sexually transmitted diseases?

No. The label says the use of tadalafil tablets offers no protection against sexually transmitted diseases, including HIV.

Can tadalafil be used with nitrate medicines?

The label says no. Tadalafil is contraindicated with any form of organic nitrate. The label says at least 48 hours should pass after the last tadalafil dose before nitrates are considered, and only under close medical supervision in a life-threatening situation.

Does the label say what happens if I drink alcohol?

The label says substantial alcohol use (5 units or greater) with tadalafil can increase dizziness, headache, heart rate increases, and drops in standing blood pressure.

What should I do if I notice sudden vision loss while taking tadalafil?

The label says to stop all PDE5 inhibitors, including tadalafil, and seek medical attention right away. It says this may be a sign of NAION.

🧪 Tests and reports linked to Tadalafil

The label text mentions these. If you have one of these reports, get every line of it explained.

📖 Medical words used on this page

  • Allergic reaction

    An allergic reaction is when the immune system overreacts to something harmless, such as a medicine or food, causing symptoms from a rash to swelling.

  • Angina

    Angina is chest pain or tightness caused by the heart muscle not getting enough blood and oxygen, usually from narrowed heart arteries.

  • Anterior and posterior

    Anterior means toward the front of the body and posterior means toward the back, so both words describe where something is.

  • Aortic Stenosis

    Aortic stenosis means the aortic valve of the heart is narrowed, so the heart must work harder to push blood out to the body.

  • Arrhythmia

    An arrhythmia is a heartbeat that is too fast, too slow or irregular, because the heart's electrical signals are not working in their usual pattern.

  • Benign

    Benign means not cancer. A benign growth does not spread to other parts of the body.

  • Benign prostatic hyperplasia

    Benign prostatic hyperplasia (BPH) is non-cancerous growth of the prostate gland, common with age, which can make passing urine harder.

  • Contraindication

    A contraindication is a reason not to use a particular medicine, test or procedure for a person because it could cause harm.

  • CYP3A

    CYP3A is a family of enzymes, mainly in the liver and gut, that break down a large share of commonly used medicines.

  • CYP3A4

    CYP3A4 is a liver and gut enzyme that breaks down many medicines. Drugs or foods that block or boost it can change medicine levels.

  • Erectile dysfunction

    Erectile dysfunction (ED) means difficulty getting or keeping an erection firm enough for sex. It is common and often treatable.

  • Heart failure

    Heart failure means the heart is not pumping or filling as well as it should, so it struggles to meet the body's needs. It does not mean the heart has stopped.

  • Hemodialysis

    Hemodialysis is a treatment where a machine filters the blood to remove waste and extra fluid when the kidneys cannot do it well enough.

  • HIV-1

    HIV-1 is the most common type of human immunodeficiency virus, which attacks immune cells and is treated with antiretroviral medicines.

📖 Medical words on this page

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Source: official FDA drug label (label updated 2026-06-24). Read the full label on DailyMed

MedicDecode explains the official label in plain words. It is not medical advice and does not replace your doctor or pharmacist. Never start, stop or change a medicine because of what you read here.