Does Tadalafil (Cialis) cause male infertility?

From the Guidelines

Tadalafil does not cause infertility, as there is no evidence from clinical studies or post-marketing surveillance that it negatively impacts male fertility parameters such as sperm count, motility, or morphology. This medication, commonly known by the brand name Cialis, is a phosphodiesterase type 5 (PDE5) inhibitor used to treat erectile dysfunction and benign prostatic hyperplasia. According to the most recent guideline updates on male infertility 1, there is no mention of tadalafil as a cause of infertility. In fact, some research suggests that PDE5 inhibitors like tadalafil might potentially improve certain fertility parameters in some men by enhancing blood flow to reproductive organs.

The typical dosing of tadalafil ranges from 2.5mg to 20mg depending on whether it's taken daily or as needed before sexual activity. While tadalafil may cause side effects such as headache, indigestion, back pain, muscle aches, flushing, or nasal congestion, these are temporary and not related to fertility. Men concerned about fertility while taking tadalafil can be reassured that this medication does not compromise their reproductive potential. It's worth noting that the diagnosis and treatment of infertility in men, as outlined in the AUA/ASRM guideline part II 1, do not mention tadalafil as a factor contributing to male infertility.

Key points to consider:

• Tadalafil is not listed as a cause of infertility in the latest guidelines 1
• PDE5 inhibitors like tadalafil may potentially improve fertility parameters by enhancing blood flow to reproductive organs
• Tadalafil's side effects are temporary and not related to fertility
• Men taking tadalafil for erectile dysfunction or benign prostatic hyperplasia can be reassured that it does not compromise their reproductive potential.

From the FDA Drug Label

1. 3 Females and Males of Reproductive Potential Infertility Based on the data from 3 studies in adult males, tadalafil decreased sperm concentrations in the study of 10 mg tadalafil for 6 months and the study of 20 mg tadalafil for 9 months. This effect was not seen in the study of 20 mg tadalafil taken for 6 months There was no adverse effect of tadalafil 10 mg or 20 mg on mean concentrations of testosterone, luteinizing hormone or follicle stimulating hormone. The clinical significance of the decreased sperm concentrations in the two studies is unknown. There have been no studies evaluating the effect of tadalafil on fertility in men [see Clinical Pharmacology (12 . 2)]. Based on studies in animals, a decrease in spermatogenesis was observed in dogs, but not in rats [see Nonclinical Toxicology (13.1)].

Tadalafil and Infertility:

• Tadalafil may decrease sperm concentrations in some men, but the clinical significance of this effect is unknown.
• There have been no studies evaluating the effect of tadalafil on fertility in men.
• Animal studies have shown a decrease in spermatogenesis in dogs, but not in rats.
• The FDA drug label does not provide conclusive evidence that tadalafil causes infertility in humans 2.

From the Research

Tadalafil and Infertility

• There is no evidence to suggest that Tadalafil causes infertility, as studies have shown that it has no adverse effects on spermatogenesis or reproductive hormones 3.
• A study published in The Journal of Urology found that Tadalafil had no detrimental effect on human spermatogenesis or reproductive hormones, even when administered daily for 6 months at doses of 10 and 20 mg 3.
• Other studies have focused on the efficacy and safety of Tadalafil in treating erectile dysfunction, rather than its effects on fertility 4, 5, 6, 7.
• These studies have shown that Tadalafil is effective and well-tolerated in treating erectile dysfunction, but do not provide information on its potential impact on fertility.
• Overall, the available evidence suggests that Tadalafil is unlikely to cause infertility, but further research may be needed to fully understand its effects on reproductive health.