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A three-part study to investigate the incidence and potential etiologies of tadalafil-associated back pain or myalgia

Abstract

The potential mechanisms underlying back pain and/or myalgia experienced by men taking tadalafil were investigated. An integrated analysis of 10 placebo-controlled tadalafil clinical trials (N=1846) showed that the incidence of back pain and/or myalgia was 9.4% in patients receiving tadalafil 10 mg (N=394), 8.3% in patients receiving tadalafil 20 mg (N=883) and 3.7% in placebo-treated patients (N=569). One (0.3%) patient receiving tadalafil 10 mg, six (0.7%) patients receiving tadalafil 20 mg, and no patients receiving placebo discontinued treatment due to back pain and/or myalgia. In a prospective study in healthy volunteers, no substantial changes were observed in laboratory markers indicative of inflammation or muscle damage, and tadalafil did not affect renal plasma flow nor produce lumbar or gluteal myositis by positron emission tomography scan or magnetic resonance imaging. Although the mechanism of back pain and/or myalgia remains unknown, these events appear to be self-limiting and a general effect of phosphodiesterase 5 inhibition.

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Acknowledgements

Funding for this and the parent studies was provided by Lilly ICOS LLC. We wish to thank Chris Fischer of ICOS Corporation for his assistance in the preparation of the manuscript.

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Correspondence to A D Seftel.

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Seftel, A., Farber, J., Fletcher, J. et al. A three-part study to investigate the incidence and potential etiologies of tadalafil-associated back pain or myalgia. Int J Impot Res 17, 455–461 (2005). https://doi.org/10.1038/sj.ijir.3901374

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  • DOI: https://doi.org/10.1038/sj.ijir.3901374

Keywords

  • impotence
  • phosphodiesterase inhibitors
  • back pain
  • myositis

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