Tadalafil Safety Information

What Is This Medication?

Tadalafil is a phosphodiesterase type 5 (PDE5) inhibitor used to treat erectile dysfunction (ED) in adult men. Tadalafil works by relaxing blood vessels and increasing blood flow to the penis during sexual stimulation. It is the active ingredient originally found in Cialis. A key distinction of tadalafil is its longer duration of action, lasting up to 36 hours, which has earned it the name "the weekend pill." Tadalafil can be prescribed for as-needed use (taken before sexual activity) or as a lower daily dose for continuous readiness.

Who Should Consider This Treatment?

Tadalafil may be appropriate for adult men who experience difficulty achieving or maintaining erections. It is particularly suitable for men who prefer a longer window of effectiveness or the flexibility of a daily low-dose option that does not require timing around sexual activity. Your healthcare provider will evaluate your cardiovascular health, medical history, and current medications to determine if tadalafil is appropriate for you.

Who Should Not Use This Medication?

Do not use tadalafil if you:

• Take nitrates in any form(nitroglycerin, isosorbide mononitrate, isosorbide dinitrate, or recreational nitrates such as amyl nitrite or "poppers"). Combining tadalafil with nitrates can cause a sudden, dangerous drop in blood pressure that may be fatal.
• Take riociguat (Adempas), a medication for pulmonary arterial hypertension
• Have severe cardiovascular disease, including unstable angina, uncontrolled high blood pressure, or recent heart failure
• Have had a heart attack or stroke within the past six months
• Have a known hypersensitivity or allergy to tadalafil or any of its ingredients
• Have severe liver impairment

Warnings and Precautions

• Sexual activity carries cardiovascular risk. Your provider will assess your cardiac health before prescribing tadalafil. Stop sexual activity and seek medical help if you experience chest pain, dizziness, or nausea.
• Never combine tadalafil with nitrates. This includes all prescription nitrate medications and recreational nitrites. This combination can be life-threatening.
• Because tadalafil has a longer half-life than other PDE5 inhibitors, its effects on blood pressure may last longer. Use caution with blood pressure medications.
• Use caution if you have anatomical deformation of the penis or conditions that predispose to priapism (sickle cell anemia, multiple myeloma, or leukemia).
• Do not take more than the prescribed dose. Taking excess tadalafil does not improve results and increases side effect risk.

Common Side Effects

The most commonly reported side effects include:

• Headache
• Back pain (more common with tadalafil than other PDE5 inhibitors)
• Muscle aches (myalgia), particularly in the legs
• Nasal congestion or runny nose
• Dyspepsia (indigestion or upset stomach)
• Facial flushing (redness or warmth)
• Limb pain

Back pain and muscle aches typically occur 12 to 24 hours after taking tadalafil and usually resolve within 48 hours. Over-the-counter pain relief may help manage these symptoms. Contact your provider if side effects persist or become bothersome.

Serious Side Effects

Seek immediate medical attention if you experience any of the following:

• Priapism: An erection lasting more than four hours. This is a medical emergency. Seek treatment immediately to prevent permanent damage to the penis.
• Sudden vision loss in one or both eyes, which may indicate non-arteritic anterior ischemic optic neuropathy (NAION). Discontinue use and seek emergency care.
• Sudden hearing loss or decrease in hearing, with or without ringing in the ears or dizziness
• Severe hypotension: Sudden drop in blood pressure causing fainting, severe dizziness, or lightheadedness
• Severe back pain that is debilitating or accompanied by numbness, weakness, or loss of bladder or bowel control
• Chest pain, irregular heartbeat, or shortness of breath during or after sexual activity

Drug Interactions

Tell your healthcare provider about all medications you are taking. Tadalafil has important interactions with several drug classes:

• Nitrates (ABSOLUTE CONTRAINDICATION): Nitroglycerin, isosorbide mononitrate, isosorbide dinitrate, and recreational nitrites. This combination can cause fatal hypotension. Because tadalafil remains active for up to 36 hours, the risk window is longer than with shorter-acting PDE5 inhibitors.
• Alpha-blockers (tamsulosin, doxazosin, prazosin): May cause additive blood pressure lowering. Your provider may start tadalafil at a lower dose or adjust your alpha-blocker if needed.
• CYP3A4 inhibitors (ketoconazole, itraconazole, ritonavir, erythromycin, clarithromycin): These medications can increase tadalafil levels in your blood. Dose adjustment may be required.
• Other PDE5 inhibitors: Do not use tadalafil with sildenafil, vardenafil, or avanafil. Combining PDE5 inhibitors increases the risk of serious adverse effects.
• Blood pressure medications: Tadalafil may enhance the blood pressure-lowering effects of antihypertensive drugs.
• Alcohol: Excessive alcohol consumption with tadalafil can increase the risk of dizziness, low blood pressure, and headache.

Before Starting Treatment

Before taking tadalafil, inform your healthcare provider if you:

• Have heart disease, a history of heart attack, or irregular heartbeat
• Have high or low blood pressure
• Have a history of stroke
• Have liver or kidney problems
• Have a blood disorder such as sickle cell anemia, multiple myeloma, or leukemia
• Have a bleeding disorder or active peptic ulcer
• Have a physical deformity of the penis
• Have retinitis pigmentosa or a history of vision problems
• Take medications for blood pressure, prostate conditions, or HIV

How to Use This Medication

Tadalafil is taken by mouth as a tablet. There are two prescribing approaches. For as-needed use, take the prescribed dose at least 30 minutes before sexual activity. The effects can last up to 36 hours, so you do not need to time your dose as precisely as with shorter-acting medications. For daily use, take a lower dose at the same time each day, regardless of when you plan sexual activity. This approach provides continuous readiness. Tadalafil can be taken with or without food. Do not take more than one as-needed dose in a 24-hour period, and do not combine as-needed and daily dosing. Store at room temperature, away from moisture and heat.