Skip to main content

Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.

  • Article
  • Published:

Medications mostly associated with priapism events: assessment of the 2015–2020 Food and Drug Administration (FDA) pharmacovigilance database entries

Abstract

A range of drugs have a direct role in triggering ischaemic priapism. We aimed at identifying: a) which medications are associated with most priapism-reports; and, b) within these medications, comparing their potential to elicit priapism through a disproportionality analysis. The FDA Adverse Event Reporting System (FAERS) database was queried to identify those drugs associated the most with priapism reports over the last 5 years. Only those drugs being associated with a minimum of 30 priapism reports were considered. The Proportional Reporting Ratios (PRRs), and their 95% confidence intervals were computed. Out of the whole 2015–2020 database, 1233 priapism reports were identified, 933 of which (75.7%) were associated with 11 medications with a minimum of 30 priapism-reports each. Trazodone, olanzapine and tadalafil showed levels of disproportionate reporting, with a PRR of 9.04 (CI95%: 7.73–10.58), 1.55 (CI95%: 1.27–1.89), and 1.42 (CI95%: 1.10–1.43), respectively. Most (57.5%) of the reports associated with the phosphodiesterase type 5 inhibitors (PDE5Is) were related with concomitant priapism-eliciting drugs taken at the same time and/or inappropriate intake/excessive dosage. Patients taking trazodone and/or antipsychotics need to be aware of the priapism-risk; awareness among prescribers would help in reducing priapism-related detrimental sequelae; PDE5I-intake is not responsible for priapism by itself, when appropriate medical supervision is provided.

This is a preview of subscription content, access via your institution

Access options

Rent or buy this article

Prices vary by article type

from$1.95

to$39.95

Prices may be subject to local taxes which are calculated during checkout

Similar content being viewed by others

Data availability

The datasets generated during the current study are available in the FDA Adverse Event Reporting System (FAERS) Public Dashboard repository, https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/fda-adverse-event-reporting-system-faers-public-dashboard

References

  1. Salonia A, Eardley I, Giuliano F, Hatzichristou D, Moncada I, Vardi Y, et al. European association of urology guidelines on priapism. Eur Urol. 2014;65:480–9. https://doi.org/10.1016/j.eururo.2013.11.008

    Article  PubMed  Google Scholar 

  2. Salonia A, Bettocchi C, Boeri L, Capogrosso P, Carvalho J, Cilesiz NC, et al. EAU Working Group on Male Sexual and Reproductive Health. European Association of Urology Guidelines on Sexual and Reproductive Health-2021 Update: Male Sexual Dysfunction. Eur Urol. 2021;80:333–57.

  3. Arrichiello A, Angileri SA, Buccimazza G, Di Bartolomeo F, Di Meglio L, Liguori A, et al. Interventional radiology management of high flow priapism: review of the literature. Acta Biomed. 2020;91:e2020010 https://doi.org/10.23750/abm.v91i10-S.10233

    Article  PubMed  PubMed Central  Google Scholar 

  4. Zacharakis E, Garaffa G, Raheem AA, Christopher AN, Muneer A, Ralph DJ. Penile prosthesis insertion in patients with refractory ischaemic priapism: early vs delayed implantation. BJU Int. 2014;114:576–81. https://doi.org/10.1111/bju.12686

    Article  PubMed  Google Scholar 

  5. Eland IA, Van der Lei J, Stricker BHC, Sturkenboom MJCM. Incidence of priapism in the general population. Urology. 2001;57:970–2. https://doi.org/10.1016/S0090-4295(01)00941-4

    Article  CAS  PubMed  Google Scholar 

  6. Hwang T, Shah T, Sadeghi-Nejad H. A review of antipsychotics and priapism. Sex Med Rev. 2021;9:464–71. https://doi.org/10.1016/j.sxmr.2020.10.003

    Article  PubMed  Google Scholar 

  7. Rubin R. Use of illicit drugs continues to rise. JAMA. 2019;322:1543 https://jamanetwork.com/journals/jama/article-abstract/2753347 accessed 18 Aug 2021

    PubMed  Google Scholar 

  8. Zhao H, Berdahl C, Bresee C, Moradzadeh A, Houman J, Kim H, et al. Priapism from recreational intracavernosal injections in a high-risk metropolitan community. J Sex Med. 2019;16:1650–4. https://doi.org/10.1016/j.jsxm.2019.07.024

    Article  PubMed  PubMed Central  Google Scholar 

  9. Montastruc JL, Sommet A, Bagheri H, Lapeyre-Mestre M. Benefits and strengths of the disproportionality analysis for identification of adverse drug reactions in a pharmacovigilance database. Br J Clin Pharmacol. 2011. https://doi.org/10.1111/j.1365-2125.2011.04037.x.

  10. Kumar A. The newly available FAERS public dashboard: implications for health care professionals. Hosp Pharm. 2019;54:75–7. https://doi.org/10.1177/0018578718795271

    Article  PubMed  Google Scholar 

  11. EMA. Guideline on good pharmacovigilance practices (GVP) Annex I—Definitions (Rev 4). Heads Med Agencies. 2017.

  12. Schifano N, Chiappini S, Castiglione F, Salonia A, Schifano F. Is medicinal ketamine associated with urinary dysfunction issues? Assessment of both the European Medicines Agency (EMA) and the UK Yellow Card Scheme pharmacovigilance database-related reports. Low Urin Tract Symptoms. 2020.

  13. Chiappini S, Schifano F. A decade of gabapentinoid misuse: an analysis of the European Medicines Agency’s ‘suspected adverse drug reactions’ database. CNS Drugs. 2016;30:647–54. https://doi.org/10.1007/s40263-016-0359-y

    Article  PubMed  Google Scholar 

  14. European Medicines Agency. Guideline on the use of statistical signal detection methods in the EudraVigilance data analysis system. 2008.

  15. WHO. The WHO Programme for International Drug Monitoring. 2015.

  16. Felicetti P, Trotta F, Bonetto C, Santuccio C, Brauchli Pernus Y, Burgner D, et al. Spontaneous reports of vasculitis as an adverse event following immunization: a descriptive analysis across three international databases. Vaccine. 2016. https://doi.org/10.1016/j.vaccine.2015.09.027.

  17. Scherzer ND, Reddy AG, Le TV, Chernobylsky D, Hellstrom WJG. Unintended consequences: a review of pharmacologically-induced priapism. Sex Med Rev. 2019;7:283–92. https://doi.org/10.1016/j.sxmr.2018.09.002

    Article  PubMed  Google Scholar 

  18. Grundmark B, Holmberg L, Garmo H, Zethelius B. Reducing the noise in signal detection of adverse drug reactions by standardizing the background: a pilot study on analyses of proportional reporting ratios-by-therapeutic area. Eur J Clin Pharm. 2014. https://doi.org/10.1007/s00228-014-1658-1

    Article  Google Scholar 

  19. Dutta R, Matz EL, Overholt TL, Anderson WB, Deebel NA, Cowper M, et al. Patient education is associated with reduced delay to presentation for management of ischemic priapism: a retrospective review of 123 men. J Sex Med. 2021;18:385–90. https://doi.org/10.1016/j.jsxm.2020.11.017

    Article  CAS  PubMed  Google Scholar 

  20. Shah T, Deolanker J, Luu T, Sadeghi-Nejad H. Pretreatment screening and counseling on prolonged erections for patients prescribed trazodone. Investig Clin Urol. 2021;62:85–9. https://doi.org/10.4111/icu.20200195

    Article  PubMed  Google Scholar 

  21. Matz A, Ambinder D, Spencer E, Phillips J, Wong NC. Review of priapism litigation in the United States. Urology. 2021. https://doi.org/10.1016/j.urology.2021.05.001.

  22. Panchatsharam PK, Durland J, Zito PM. Physiology, erection. physiol erection [Updated 9 May 2021] 2021: In: StatPearls [Internet]. Treasure Island (FL). https://www.ncbi.nlm.nih.gov/books/NBK513278/ (accessed 18 Aug 2021).

  23. Traish A, Kim NN, Moreland RB, Goldstein I. Role of alpha adrenergic receptors in erectile function. Int J Impot Res. 2000;12:S48–63. https://doi.org/10.1038/sj.ijir.3900506

    Article  CAS  PubMed  Google Scholar 

  24. Greiner T, Schneider M, Regente J, Toto S, Bleich S, Grohmann R, et al. Priapism induced by various psychotropics: a case series. World J Biol Psychiatry. 2019;20:505–12. https://doi.org/10.1080/15622975.2018.1520396

    Article  PubMed  Google Scholar 

  25. Dent LA, Brown WC, Murney JD. Citalopram-induced priapism. Pharmacotherapy. 2002;22:538–41.

  26. Trivedi SK, Mangot AG, Sinha S. Aripiprazole-induced priapism n.d.

  27. Koirala S, Penagaluri P, Smith C, Lippmann S. Priapism and risperidone. South Med J. 2009;102:1266–8. https://doi.org/10.1097/SMJ.0b013e3181c04775

    Article  PubMed  Google Scholar 

  28. Goldmeier D. Prolonged erections produced by dihydrocodeine and sildenafil. BMJ. 2002;312:44 https://doi.org/10.1136/bmj.312.7022.44

    Article  Google Scholar 

  29. Aoyagi T, Hayakawa K, Miyaji K, Ishikawa H, Hata M. Sildenafil induced priapism. Bull Tokyo Dent Coll. 1999;40:215–7. https://doi.org/10.2209/tdcpublication.40.215

    Article  CAS  PubMed  Google Scholar 

  30. Cantrell FL. Sildenafil citrate ingestion in a pediatric patient. Pediatr Emerg Care. 2004;20:314–5. https://doi.org/10.1097/01.pec.0000125660.50937.b5

    Article  PubMed  Google Scholar 

  31. Kumar R, Cantrell FL, Galatti L, Fioravanti A, Salvo F, Polimeni G, et al. Penile fracture after priapism due to sildenafil ingestion: out of frying pan into the fire. J Anal Toxicol. 2015;39:314–5. https://doi.org/10.1182/blood.v95.5.1878

    Article  Google Scholar 

  32. Galatti L, Fioravanti A, Salvo F, Polimeni G, Giustini SE. Interaction between tadalafil and itraconazole [4]. Ann Pharmacother. 2005;39:200 https://doi.org/10.1345/aph.1E383

    Article  PubMed  Google Scholar 

  33. Kassim AA, Fabry ME, Nagel RL. Acute priapism associated with the use of sildenafil in a patient with sickle cell trait [3]. Blood. 2000;95:1878–9. https://doi.org/10.1182/blood.v95.5.1878

    Article  CAS  PubMed  Google Scholar 

  34. Matheeussen V, Maudens KE, Anseeuw K, Neels H. A non-fatal self-poisoning attempt with sildenafil. J Anal Toxicol. 2015;39:572–6. https://doi.org/10.1093/jat/bkv071

    Article  CAS  PubMed  Google Scholar 

  35. Sharma D, Kumar M, Pandey S, Agarwal S. Penile fracture after priapism due to sildenafil ingestion: out of frying pan into the fire. BMJ Case Rep. 2018;2018:1–2. https://doi.org/10.1136/bcr-2018-226562

    Article  Google Scholar 

  36. Khan QS, Tucker P, Lokhande A. Priapism: what cause: mental illness, psychotropic medications or poly-substance abuse? J Okla State Med Assoc. 2016;109:515–7.

    PubMed  Google Scholar 

  37. Rezaee ME, Gross MS. Are we overstating the risk of priapism with oral phosphodiesterase type 5 inhibitors? J Sex Med. 2020;17:1579–82. https://doi.org/10.1016/j.jsxm.2020.05.019

    Article  CAS  PubMed  Google Scholar 

  38. McLeod AL, McKenna CJ, Northridge DB. Myocardial infarction following the combined recreational use of Viagra and cannabis. Clin Cardiol. 2002;25:133–4. https://doi.org/10.1002/clc.4960250310

    Article  CAS  PubMed  Google Scholar 

  39. Bechara A, Casabé A, De Bonis W, Helien A, Bertolino MV. Recreational use of phosphodiesterase type 5 inhibitors by healthy young men. J Sex Med. 2010;7:3736–42. https://doi.org/10.1111/j.1743-6109.2010.01965.x

    Article  PubMed  Google Scholar 

  40. Gebreyohannes EA, Bhagavathula AS, Gebresillassie BM, Tefera YG, Belachew SA, Erku DA. Recreational use of phosphodiesterase 5 inhibitors and its associated factors among undergraduate male students in an Ethiopian University: a cross-sectional study. World J Mens Health. 2016;34:186–93. https://doi.org/10.5534/wjmh.2016.34.3.186

    Article  PubMed  PubMed Central  Google Scholar 

Download references

Acknowledgements

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

Author information

Authors and Affiliations

Authors

Contributions

Conception of the work: NS and FS; Data collection: NS, GF and OC; Data analysis and interpretation: NS, PC, LB, FC, HA, AM, FD, FM, FS and AS; Drafting the article: NS and FS; Critical revision of the article: PC, LB, GF, OC, FC, HA, AM, FD, FS, FM and AS; Final approval of the version to be published: NS, PC, LB, GF, OC, FC, HA, AM, FD, FS, FM and AS.

Corresponding author

Correspondence to Andrea Salonia.

Ethics declarations

Competing interests

The authors declare no competing interests.

Additional information

Publisher’s note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Schifano, N., Capogrosso, P., Boeri, L. et al. Medications mostly associated with priapism events: assessment of the 2015–2020 Food and Drug Administration (FDA) pharmacovigilance database entries. Int J Impot Res 36, 50–54 (2024). https://doi.org/10.1038/s41443-022-00583-3

Download citation

  • Received:

  • Revised:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1038/s41443-022-00583-3

This article is cited by

Search

Quick links