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Side-effect profile of sildenafil citrate (Viagra) in clinical practice.
Urology. 2000 Sep 01; 56(3):474-6.U

Abstract

OBJECTIVES

Sildenafil citrate (Viagra) has been shown to be an effective treatment for erectile dysfunction. Initial studies reported a high tolerability and low incidence of certain characteristic adverse reactions. We sought to evaluate the incidence of side effects of sildenafil citrate, independent of industry support and constraints, utilizing a heterogeneous cohort of patients from a university-based practice.

METHODS

A prospective, open-label, flexible-dose study of 256 patients treated with sildenafil citrate for erectile dysfunction was performed at a single institution. The patients were questioned explicitly about the occurrence of headache, flushing, dyspepsia, nasal congestion, visual changes, and other side effects.

RESULTS

The adverse reactions most commonly observed were flushing (30.8%), headache (25. 4%), nasal congestion (18.7%), and heartburn (10.5%). All events were short lived and mild in nature. In the present study, 31.6% of patients experienced one or more adverse events. However, no one withdrew from the study because of the severity of these events. There was a significant association between higher doses and the occurrence of side effects.

CONCLUSIONS

The incidence of adverse events attributable to sildenafil citrate may be higher than initially reported, but an explanation may be the methodology of data collection and the industry-independent nature of this study. The side-effect profile is dose related and mild. Sildenafil citrate remains a safe and well-tolerated treatment for erectile dysfunction.

Authors+Show Affiliations

Scott Department of Urology, Baylor College of Medicine, Houston, Texas, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

10962318

Citation

Moreira, S G., et al. "Side-effect Profile of Sildenafil Citrate (Viagra) in Clinical Practice." Urology, vol. 56, no. 3, 2000, pp. 474-6.
Moreira SG, Brannigan RE, Spitz A, et al. Side-effect profile of sildenafil citrate (Viagra) in clinical practice. Urology. 2000;56(3):474-6.
Moreira, S. G., Brannigan, R. E., Spitz, A., Orejuela, F. J., Lipshultz, L. I., & Kim, E. D. (2000). Side-effect profile of sildenafil citrate (Viagra) in clinical practice. Urology, 56(3), 474-6.
Moreira SG, et al. Side-effect Profile of Sildenafil Citrate (Viagra) in Clinical Practice. Urology. 2000 Sep 1;56(3):474-6. PubMed PMID: 10962318.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Side-effect profile of sildenafil citrate (Viagra) in clinical practice. AU - Moreira,S G,Jr AU - Brannigan,R E, AU - Spitz,A, AU - Orejuela,F J, AU - Lipshultz,L I, AU - Kim,E D, PY - 2000/8/30/pubmed PY - 2000/9/23/medline PY - 2000/8/30/entrez SP - 474 EP - 6 JF - Urology JO - Urology VL - 56 IS - 3 N2 - OBJECTIVES: Sildenafil citrate (Viagra) has been shown to be an effective treatment for erectile dysfunction. Initial studies reported a high tolerability and low incidence of certain characteristic adverse reactions. We sought to evaluate the incidence of side effects of sildenafil citrate, independent of industry support and constraints, utilizing a heterogeneous cohort of patients from a university-based practice. METHODS: A prospective, open-label, flexible-dose study of 256 patients treated with sildenafil citrate for erectile dysfunction was performed at a single institution. The patients were questioned explicitly about the occurrence of headache, flushing, dyspepsia, nasal congestion, visual changes, and other side effects. RESULTS: The adverse reactions most commonly observed were flushing (30.8%), headache (25. 4%), nasal congestion (18.7%), and heartburn (10.5%). All events were short lived and mild in nature. In the present study, 31.6% of patients experienced one or more adverse events. However, no one withdrew from the study because of the severity of these events. There was a significant association between higher doses and the occurrence of side effects. CONCLUSIONS: The incidence of adverse events attributable to sildenafil citrate may be higher than initially reported, but an explanation may be the methodology of data collection and the industry-independent nature of this study. The side-effect profile is dose related and mild. Sildenafil citrate remains a safe and well-tolerated treatment for erectile dysfunction. SN - 1527-9995 UR - https://www.unboundmedicine.com/medline/citation/10962318/Side_effect_profile_of_sildenafil_citrate__Viagra__in_clinical_practice_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0090-4295(00)00649-X DB - PRIME DP - Unbound Medicine ER -