Side effects reported by European consumers for medications for erectile dysfunction

Area of Science:

• Pharmacovigilance
• Drug Safety
• Consumer Health

Background:

• Phosphodiesterase type 5 (PDE5) inhibitors are widely used medications.
• Understanding consumer-reported adverse drug reactions (ADRs) is crucial for drug safety monitoring.
• European regulatory databases collect ADR reports for post-marketing surveillance.

Purpose of the Study:

• To characterize consumer-reported adverse drug reactions (ADRs) associated with phosphodiesterase type 5 (PDE5) inhibitors.
• To analyze the types and seriousness of ADRs reported by adult consumers.
• To identify common ADRs for specific PDE5 inhibitors.

Main Methods:

• Analysis of ADR reports submitted by adults to the European Medicines Agency database (EudraVigilance).
• Data collection spanned from 2007 to 2011.
• ADRs were classified by type, seriousness, consumer age, and sex.

Main Results:

• A total of 328 ADRs were reported for sildenafil and vardenafil.
• Only 5% of the reported ADRs were classified as serious.
• The most frequent ADRs for sildenafil were "lack of efficacy" or "drug efficacy decreased" (n=134) and "headache" (n=21).

Conclusions:

• Consumer-reported ADRs for PDE5 inhibitors are relatively uncommon.
• The majority of reported ADRs for these drugs are not serious.
• Findings support a generally favorable safety profile from a consumer reporting perspective.