What Is Cialis 40 mg?

Cialis 40 mg is not an FDA-approved strength or dosing regimen for erectile dysfunction (ED). Cialis (tadalafil) is approved for ED in strengths of 2.5 mg, 5 mg, 10 mg, and 20 mg. The 20 mg dose is the maximum recommended dose for use as needed.

However, tadalafil 40 mg does exist as a separate FDA-approved product—marketed under the brand name ADCIRCA—for a completely different condition: pulmonary arterial hypertension (PAH). The two products contain the same active ingredient but are not interchangeable and serve different patient populations.

Critical warning: Cialis and ADCIRCA are both tadalafil, but they are not the same medication in terms of approved use. Do not take both Cialis and ADCIRCA together. Do not take Cialis if you are taking ADCIRCA or any other tadalafil-containing product.

What Tadalafil 40 mg (ADCIRCA) Is Prescribed For

The 40 mg once-daily dose of tadalafil is FDA-approved for one condition:

• Pulmonary Arterial Hypertension (PAH) (WHO Group 1): To improve exercise ability in patients with PAH. Studies establishing effectiveness included predominantly patients with NYHA Functional Class II–III symptoms and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (23%).

Important limitation: Tadalafil 40 mg is not approved for erectile dysfunction. Using this dose for ED is outside FDA-approved labeling and has not been established as safe or effective for that purpose.

Active Ingredients

The active ingredient is tadalafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).

ADCIRCA 40 mg is supplied as 20 mg tablets; the 40 mg dose is taken as two 20 mg tablets once daily. The tablets are orange, film-coated, almond-shaped, and debossed with “4467”.

Cialis is supplied in 2.5 mg, 5 mg, 10 mg, and 20 mg strengths. There is no 40 mg Cialis tablet.

Dosage Guidelines

• For PAH (ADCIRCA): The recommended dose is 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.
• For ED (Cialis): The recommended starting dose for use as needed is 10 mg, taken prior to anticipated sexual activity. The dose may be increased to 20 mg or decreased to 5 mg based on efficacy and tolerability. The maximum recommended dosing frequency is once per day. The maximum approved ED dose is 20 mg—not 40 mg.
• For Once-Daily Use (ED or BPH): The recommended starting dose is 2.5 mg for ED, and 5 mg for BPH, taken at approximately the same time every day.

Important Safety Information

Contraindications (Applies to All Tadalafil Products):

Tadalafil is contraindicated in patients taking nitrates in any form (including recreational “poppers” such as amyl nitrite and butyl nitrite) and guanylate cyclase stimulators such as riociguat (Adempas). Tadalafil is also contraindicated in patients with known serious hypersensitivity to tadalafil, including Stevens-Johnson syndrome and exfoliative dermatitis.

Cardiovascular Risks:

Tadalafil has vasodilatory properties that may result in transient decreases in blood pressure. Patients should not use tadalafil if sex is inadvisable due to cardiovascular status. Specific cardiovascular contraindications include: myocardial infarction within the last 90 days, unstable angina or angina occurring during sexual intercourse, NYHA Class 2 or greater heart failure in the last 6 months, uncontrolled arrhythmias, hypotension (<90/50 mm Hg), uncontrolled hypertension, or stroke within the last 6 months.

Visual Loss (NAION):

Non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported postmarketing with PDE5 inhibitor use. Patients should stop tadalafil and seek medical attention for sudden loss of vision.

Sudden Hearing Loss:

Cases of sudden decrease or loss of hearing have been reported. Patients should stop tadalafil and seek prompt medical attention.

Prolonged Erection and Priapism:

There have been reports of prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours). Priapism, if not treated promptly, can result in irreversible damage to the erectile tissue. Seek emergency medical attention if an erection lasts more than 4 hours.

Common Side Effects (40 mg PAH Dose)

In the placebo-controlled PAH trial, treatment-emergent adverse events reported by ≥9% of patients in the tadalafil 40 mg group and occurring more frequently than placebo by 2% included:

Headache 15% 42% Myalgia 4% 14% Nasopharyngitis 7% 13% Flushing 2% 13% Respiratory Tract Infection 6% 13% Pain in Extremity 2% 11% Nausea 6% 11% Back Pain 6% 10% Dyspepsia 2% 10% Nasal Congestion 1% 9%The overall rate of discontinuation because of an adverse event in the placebo-controlled trial was 9% for tadalafil 40 mg and 15% for placebo.

Drug Interactions

• Nitrates: Tadalafil potentiates the hypotensive effect of nitrates. Do not use nitrates within 48 hours of the last dose of tadalafil. This combination is contraindicated.
• CYP3A4 Inhibitors (e.g., ketoconazole, ritonavir): Potent inhibitors increase tadalafil exposure. For PAH, co-administration with ritonavir requires starting at 20 mg once daily and increasing to 40 mg based on tolerability.
• CYP3A4 Inducers (e.g., rifampin, bosentan): Decrease tadalafil exposure. Bosentan reduced tadalafil 40 mg systemic exposure by 42% and Cmax by 27%.
• Alpha-Blockers: Tadalafil can potentiate the blood-pressure-lowering effect of alpha-blockers. For ED, patients should be stable on alpha-blocker therapy prior to initiating tadalafil, and tadalafil should be initiated at the lowest recommended dose. For BPH, tadalafil is not recommended in combination with alpha-blockers.
• Alcohol: Substantial consumption of alcohol (≥5 units) in combination with tadalafil can increase the potential for orthostatic signs and symptoms, including increased heart rate, decreased standing blood pressure, dizziness, and headache.

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Who Should Not Take Tadalafil 40 mg

Tadalafil is contraindicated in patients with:

• Nitrate use in any form (including recreational “poppers”)
• Guanylate cyclase stimulators such as riociguat
• Known serious hypersensitivity to tadalafil (including Stevens-Johnson syndrome and exfoliative dermatitis)
• Recent cardiovascular events as listed above
• Severe hepatic impairment (Child Pugh Class C) — use is not recommended
• Severe renal impairment (creatinine clearance <30 mL/min) — avoid use because of increased tadalafil exposure, limited clinical experience, and inability to influence clearance by dialysis

How Prescriptions Work

Tadalafil 40 mg (ADCIRCA) is a prescription-only medication. Legal access requires:

• Consultation with a licensed healthcare provider to evaluate cardiovascular risk factors, current medications, and contraindications
• A valid prescription issued for a legitimate medical purpose (PAH diagnosis for the 40 mg dose)
• Filling at a verified pharmacy that requires prescription verification

Warning about illegal online sellers: The FDA and NABP warn that illegal online pharmacies often sell counterfeit medications containing unknown ingredients. Analysis of over-the-counter sexual enhancement products has found that these products may contain sildenafil or tadalafil in unknown quantities, or may contain entirely different substances.

Frequently Asked Questions

• Is Cialis 40 mg available for erectile dysfunction? No. The maximum FDA-approved dose of Cialis for erectile dysfunction is 20 mg. Tadalafil 40 mg is approved only for pulmonary arterial hypertension under the brand name ADCIRCA. Using tadalafil 40 mg for ED is outside approved labeling.
• Can I take two 20 mg Cialis tablets to make 40 mg? No. Taking 40 mg of Cialis for ED is not an approved dose and increases the risk of side effects including severe hypotension, priapism, and visual disturbances. The maximum approved ED dose is 20 mg.
• What is the difference between Cialis and ADCIRCA? Both contain tadalafil as the active ingredient. Cialis is approved for erectile dysfunction and benign prostatic hyperplasia in doses up to 20 mg. ADCIRCA is approved for pulmonary arterial hypertension in a 40 mg once-daily dose. They are not interchangeable.
• Can I take Cialis and ADCIRCA together? No. Do not take both Cialis and ADCIRCA together. Do not take Cialis if you are taking ADCIRCA or any other tadalafil-containing product.
• What happens if I take too much tadalafil? Taking more than the recommended dose increases the risk of severe side effects, including hypotension, priapism, visual disturbances, and hearing loss. Seek emergency medical attention if an erection lasts more than 4 hours or if you experience sudden vision or hearing changes.
• Is tadalafil 40 mg safe during pregnancy? Tadalafil is not indicated for use in women for ED or PAH. Safety and effectiveness in pregnant women have not been established.
• How long does tadalafil 40 mg stay in your system? Tadalafil has a mean terminal half-life of 17.5 hours in healthy subjects. Steady-state plasma concentrations are attained within 5 days of once-daily dosing.

Conclusion

Cialis 40 mg does not exist as an approved erectile dysfunction treatment. The maximum approved Cialis dose for ED is 20 mg. The 40 mg dose of tadalafil is approved only for pulmonary arterial hypertension under the brand name ADCIRCA, taken as two 20 mg tablets once daily. Both products contain tadalafil and share the same serious risks: contraindication with nitrates and guanylate cyclase stimulators, cardiovascular risks, NAION-related vision loss, sudden hearing loss, and priapism. Common side effects at the 40 mg PAH dose include headache (42%), myalgia (14%), and flushing (13%). Patients should never take Cialis and ADCIRCA together, should not exceed 20 mg for ED, and should obtain tadalafil only through a licensed provider and a verified pharmacy. Any use of tadalafil 40 mg for ED is outside FDA-approved labeling and carries increased risk of serious adverse events.