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
Subscribe to Journal
Get full journal access for 1 year
only $14.88 per issue
All prices are NET prices.
VAT will be added later in the checkout.
Tax calculation will be finalised during checkout.
Get time limited or full article access on ReadCube.
All prices are NET prices.
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
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
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.
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
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
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
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
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
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
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.
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
EMA. Guideline on good pharmacovigilance practices (GVP) Annex I—Definitions (Rev 4). Heads Med Agencies. 2017.
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.
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
European Medicines Agency. Guideline on the use of statistical signal detection methods in the EudraVigilance data analysis system. 2008.
WHO. The WHO Programme for International Drug Monitoring. 2015.
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.
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
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
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
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
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.
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).
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
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
Dent LA, Brown WC, Murney JD. Citalopram-induced priapism. Pharmacotherapy. 2002;22:538–41.
Trivedi SK, Mangot AG, Sinha S. Aripiprazole-induced priapism n.d.
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
Goldmeier D. Prolonged erections produced by dihydrocodeine and sildenafil. BMJ. 2002;312:44 https://doi.org/10.1136/bmj.312.7022.44
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
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
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
Galatti L, Fioravanti A, Salvo F, Polimeni G, Giustini SE. Interaction between tadalafil and itraconazole . Ann Pharmacother. 2005;39:200 https://doi.org/10.1345/aph.1E383
Kassim AA, Fabry ME, Nagel RL. Acute priapism associated with the use of sildenafil in a patient with sickle cell trait . Blood. 2000;95:1878–9. https://doi.org/10.1182/blood.v95.5.1878
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
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
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.
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
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
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
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
This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.
The authors declare no competing interests.
Publisher’s note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
About this article
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 (2022). https://doi.org/10.1038/s41443-022-00583-3