Important Safety Information: Tadalafil Tablets | Oral Medication

What is this?

This Important Safety Information summarizes key warnings and precautions for tadalafil, a phosphodiesterase type 5 (PDE5) inhibitor used for the treatment of erectile dysfunction (ED), the signs and symptoms of benign prostatic hyperplasia (BPH), or both ED and BPH. Tadalafil works by increasing blood flow to specific tissues in the body. This summary is based on FDA-approved prescribing information. This summary does not include all available information. Always read your medication label and follow your provider’s instructions. See full prescribing information for complete safety details. 

Most Serious Warnings

Tadalafil can cause serious side effects, including:

• Severe drop in blood pressure if taken with nitrates or guanylate cyclase (GC) stimulators

• Sudden vision loss in one or both eyes, which may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION)

• Sudden hearing decrease or loss, which may be accompanied by ringing in the ears or dizziness

• Prolonged erection lasting more than 4 hours (priapism), which can cause permanent damage if not treated promptly

• Serious cardiovascular events including chest pain, heart attack, stroke, or irregular heartbeat, particularly in individuals with underlying heart disease

Who Should NOT Take Tadalafil

Do not take this medication if you:

• Take any form of nitrate medication, including nitroglycerin or recreational “poppers” containing amyl nitrite or butyl nitrite

• Take guanylate cyclase stimulators such as riociguat

• Have a known serious allergy to tadalafil

• Have been advised by your healthcare provider to avoid sexual activity due to cardiovascular risk

Before Taking Tadalafil, Tell Your Healthcare Provider if You:

• Have heart disease, chest pain, irregular heartbeat, heart failure, or history of heart attack or stroke

• Have low blood pressure or uncontrolled high blood pressure

• Have liver or kidney disease

• Have a history of vision problems, including NAION or retinitis pigmentosa

• Have a history of hearing problems

• Have a history of blood cell disorders such as sickle cell anemia, multiple myeloma, or leukemia

• Have stomach ulcers or bleeding disorders

• Have a penile deformity or history of prolonged erections

• Take alpha-blockers, blood pressure medications, antifungals, certain antibiotics, HIV protease inhibitors, or other erectile dysfunction treatments

• Regularly consume large amounts of alcohol

Possible Side Effects

Common (mild to moderate):

• Headache

• Indigestion

• Back pain

• Muscle aches

• Flushing

• Nasal congestion

• Pain in arms or legs

Serious (seek medical care immediately):

• Chest pain, fainting, or symptoms of heart attack or stroke

• Sudden vision loss

• Sudden hearing loss

• Erection lasting more than 4 hours

• Severe allergic reaction including rash, swelling of the face or throat, or difficulty breathing

While Taking Tadalafil

Tell your healthcare provider immediately if you:

• Experience chest pain during sexual activity

• Develop sudden changes in vision or hearing

• Have dizziness, fainting, or severe drop in blood pressure

• Develop an erection lasting longer than 4 hours

• Experience severe back pain, muscle pain, or unusual swelling

Alcohol and Drug Interactions

Taking tadalafil with nitrates or guanylate cyclase stimulators is contraindicated due to risk of severe hypotension. Use caution if taking alpha-blockers or antihypertensive medications, as blood pressure may drop further. Substantial alcohol use may increase the risk of dizziness, fainting, or low blood pressure. Certain medications that affect CYP3A4 enzymes may increase or decrease tadalafil levels and require dose adjustment. 

Pregnancy and Fertility

Tadalafil is not indicated for use in women. It has not been established as safe for use during pregnancy or breastfeeding.

Overdose

Symptoms of overdose may include severe dizziness, fainting, prolonged erection, or significant drop in blood pressure. Seek emergency medical attention if overdose is suspected.

Missed Dosage

If taking tadalafil once daily and you miss a dose:

• Take it when remembered

• Do not take more than one dose per day

If using as needed, do not take more than one dose in 24 hours unless directed by your provider.

Storage

• Store at room temperature 59–86°F (15–30°C)

• Keep in original container

• Keep out of reach of children

Medication Disposal

Dispose of unused medication according to local medication disposal guidelines. Do not flush unless instructed. Consult your pharmacy for safe disposal options.

Provider Oversight and Order Review

This medication requires prescription authorization and ongoing evaluation by a licensed Superior Health and Wellness provider. Dosage adjustments may be required based on cardiovascular risk, kidney or liver function, and medication interactions.

Telemedicine Disclosure

This prescription may be issued via telemedicine. If you experience severe or concerning symptoms, contact your prescribing clinician immediately or seek emergency medical care.

Disclaimer

This summary does not include all information about tadalafil and should not replace medical guidance. Always consult your healthcare provider or pharmacist for complete safety information, potential interactions, and individualized treatment recommendations. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088.