Tadalafil

(Cialis®)

Cialis®

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Drug updated on 4/17/2024

Dosage FormTablet (oral: 2.5 mg, 5 mg, 10 mg, 20 mg)
Drug ClassPhosphodiesterase inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of erectile dysfunction (ED).
  • Indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).
  • Indicated for or the treatment of ED and the signs and symptoms of BPH (ED/BPH).

Summary
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  • Tadalafil (Cialis) is indicated for the treatment of erectile dysfunction, benign prostatic hyperplasia, and a combination of both. It has shown effectiveness in treating these conditions either alone or in combination with tamsulosin.
  • The information was derived from nine systematic reviews/meta-analyses focused on the use of tadalafil and its comparison to other drugs across various indications.
  • Compared to sildenafil in esophageal motility disorders, PDE-5 inhibitors like tadalafil are suggested to have beneficial effects, although specific comparative safety data between them were not provided.
  • In male lower urinary tract symptoms (LUTS), with or without erectile dysfunction (ED), tadalafil showed a good efficacy profile as it had lower discontinuation rates due to lack of efficacy. Its rate of discontinuation due to adverse events was also relatively low, indicating that it's well tolerated by patients.
  • When compared against all PDE5 inhibitors used for men with ED, tadalafil, along with sildenafil, were highlighted for their efficacy. However, at recommended doses, tadalafil may offer an advantageous safety profile over others, which noted side effects at higher doses.
  • Treatment using tadalafil significantly improved sperm concentration, motility, and morphology, thus showing promising results towards managing male infertility, but explicit safety data relative to this indication was not provided.

Product Monograph / Prescribing Information

Document TitleYearSource
Cialis (tadalafil) Prescribing Information.2023Lilly USA, LLC., Indianapolis, IN

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Phosphodiesterase 5 (PDE-5) inhibitors (sildenafil, tadalafil, and vardenafil) effects on esophageal motility: a systematic review2023BMC Gastroenterology
A systematic review and meta-analysis of the efficacy and safety of tamsulosin plus tadalafil compared with tamsulosin alone in treating males with lower urinary tract symptoms secondary to benign prostrate hyperplasia.2023American Journal of Men’s Health
Sexual dysfunction therapeutic approaches in patients with multiple sclerosis: a systematic review.2023Neurological Sciences
Discontinuation rates of tadalafil alone and in combination with a-blockers in the treatment of male lower urinary tract symptoms with or without coexisting erectile dysfunction: a systematic review and meta-analysis.2022International Journal of Clinical Practice
Effect of phosphodiesterase-5 inhibitors on the treatment of male infertility: a systematic review and meta-analysis. 2021The World Journal of Men's Health
Efficacy and safety of oral phosphodiesterase 5 inhibitors for erectile dysfunction: a network meta-analysis and multicriteria decision analysis. 2021World Journal of Urology
Efficacy and safety of 12-week monotherapy with once daily 5 mg tadalafil for lower urinary tract symptoms of benign prostatic hyperplasia: Evidence-based analysis.2021Frontiers in Medicine
Comparative effectiveness of tadalafil versus tamsulosin in treating lower urinary tract symptoms suggestive of benign prostate hyperplasia: a meta-analysis of randomized controlled trials.2020Medical Science Monitor
Meta-analysis of efficacy and safety of tadalafil plus tamsulosin compared with tadalafil alone in treating men with benign prostatic hyperplasia and erectile dysfunction.2019American Journal of Men’s Health

Clinical Practice Guidelines