Tadalafil

Cialis

Approved uses

• CIALIS ® is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: erectile dysfunction (ED) the signs and symptoms of benign prostatic hyperplasia (BPH)
• If CIALIS is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks.

Forms and strengths

• Three strengths of almond-shaped tablets are available in different sizes and different shades of yellow: 5 mg tablets debossed with "C 5" 10 mg tablets debossed with "C 10" 20 mg tablets debossed...

How it is taken

• Do not split CIALIS tablets; entire dose should be taken. CIALIS 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.
• ED and BPH: 5 mg, taken at approximately the same time every day
• CIALIS may be taken without regard to food.

Must not be used when

• Administration of CIALIS to patients using any form of organic nitrate is contraindicated.
• CIALIS was shown to potentiate the hypotensive effect of nitrates.
• History of known serious hypersensitivity reaction to CIALIS or ADCIRCA ®.
• Administration with guanylate cyclase (GC) stimulators, such as riociguat.

Interactions

• CIALIS can potentiate the hypotensive effects of nitrates, alpha-blockers, antihypertensives or alcohol.
• CYP3A4 inhibitors (e.g. ketoconazole, ritonavir) increase CIALIS exposure requiring dose adjustment: CIALIS for use as needed: no more than 10 mg every 72 hours CIALIS for once daily use: dose not to exceed 2.5 mg CYP3A4 inducers (e.g. rifampin) decrease CIALIS exposure.

Warnings and precautions

• Evaluation of erectile dysfunction and BPH should include an appropriate medical assessment to identify potential underlying causes, as well as treatment options. Before prescribing CIALIS, it is important to note the following: Patients should not use CIALIS if sex is inadvisable due to cardiovascular status.
• Patients should seek emergency treatment if an erection lasts >4 hours. Use CIALIS with caution in patients predisposed to priapism. Patients should stop CIALIS and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of non-arteritic anterior ischemic optic neuropathy (NAION).

Common side effects

• Most common adverse reactions (≥2%) include headache, dyspepsia, back pain, myalgia, nasal congestion, flushing, and pain in limb.

Pregnancy

CIALIS (tadalafil) is not indicated for use in females. There are no data with the use of CIALIS in pregnant women to inform any drug-associated risks for adverse developmental outcomes. In animal reproduction studies, no adverse developmental effects were observed with oral administration of tadalafil to pregnant rats or mice during organogenesis at exposures up to 11 times the maximum recommended human dose (MRHD) of 20 mg/day (see Data).

How it acts

Penile erection during sexual stimulation is caused by increased penile blood flow resulting from the relaxation of penile arteries and corpus cavernosal smooth muscle. This response is mediated by the release of nitric oxide (NO) from nerve terminals and endothelial cells, which stimulates the synthesis of cGMP in smooth muscle cells. Cyclic GMP causes smooth muscle relaxation and increased blood flow into the corpus cavernosum.

Label holder:

Eli Lilly and Company

Label version:

3 June 2026

This section reports the approved product information. The wording is condensed from the regulator's own summary, and the full document is linked under Sources.