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In FAERs, this increase was found to predate the non-Rx/OTC switch and to be mostly explained by reporting of probable duplicates (Figure 7).

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The distribution of the 790 cases across country and calendar year is shown in Table 6 (Table 5 and 6). Table 5: Sildenafil, FAERS: ICSRs by duplicate categorization and country. Table 6: Sildenafil, FAERS: ICSRs by country and calendar year. SMARS: The query of the New Zealand SMARS database revealed 43 cases, 37 of which were deemed relevant for this analysis. Further information on data retrieved from SMARS is presented in below section (Figure 3).

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Figure 3: Flowchart of ICSRs retrieved from SMARS. In the following subsections, trends of specific countries over time are further described. Countries are presented in chronological order of the switch of sildenafil to non-prescription status. In the following analyses, the annual number of ICSRs and county-specific annual reporting rate is presented for the cases retrieved from EVDAS and FAERS. EVDAS data are stratified by seriousness and FAERS data are stratified by duplicate classification. There was no indication of a trend towards a greater proportion of fatal cases after the switch to non-prescription status in either database.

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Figure 6: EVDAS/Sildenafil/UK – Number of ICSRs and reporting rates, by seriousness.

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Figure 5: FAERS/Sildenafil/Poland – Number of ICSRs and reporting rates, by duplicate classification. The annual ICSR reporting rates for Poland were notably lower than for the other countries included in this analysis. This observation is consistent with the traditionally low rate of spontaneous ADR reporting from Poland [5]. Case characteristics: The ADRs included in the ICSRs retrieved from EVDAS and FAERS, respectively. A cluster of the ADRs ‘Death’ (N=7) in 2022 was identified.

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ICSR review revealed 7 spontaneous cases each describing ‘Intentional product use issue’ and ‘Death’ and reported into EV/FAERS by one marketing authorization holder on the same day. The cases provide only minimal information, prohibiting further assessment. Otherwise, no noteworthy ADR clusters or trends over time were observed. Patient age was reported in 32 of the 54 cases retrieved for Poland from FAERS and ranged from 30 to 71 years (median, 64 years). No contraindicated medicines were reported as concomitant or cosuspect drugs in any of the ED cases from Poland retrieved from either database. Figure 7: FAERS/Sildenafil/UK – Number of ICSRs and reporting rates, by duplicate classification.

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Possible clusters of individual ADRs (MedDRA PTs) after 2018 were consistently found to be artefacts, mostly due to probable case duplicates: A possible trend towards higher numbers of ADRs from the

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Of these, 624 cases, concerning children, females and/or treatment of PAH, were excluded. The remaining 790 cases were included in the analysis (Figure 2). Figure 2: Flowchart of ICSRs retrieved from FAERS. Of the 790 relevant cases, 686 (87%) were from the UK, 54 (7%) from Poland, 20 (3%) from Norway, 18 (2%) from New Zealand and 12 (2%) from Ireland. Consistent with the regulatory reporting requirements for foreign ICSRs into FAERS, overall case numbers per country were lower than in EVDAS and all cases but one (99.9%) were serious.

Less common

The proportion of consumer cases ranged from 15% for Norway to 72% for New Zealand (Table 4). Table 4: Sildenafil, FAERS: ICSRs by reporter type and country. In the FAERS case set, a high proportion of probable case duplicates (i.e., ICSRs reporting the same country of origin, patient age, suspect and concomitant drugs, ADRs and ADR onset dates but received from different marketing authorization holders and with different Worldwide Unique Case Identification numbers) was apparent: overall, 391 of the 790 relevant cases (49%) were categorized as probable duplicates of other cases included in the case set. In some instances, more than 10 retrieved ICSRs were found to probably refer to the same case. This phenomenon started in 2014, likely as a consequence of the launch of generic sildenafil products, which led to the same ICSRs (e.g., those detected in the scientific literature) being reported multiple times by different marketing authorization holders. SOC “Nervous system disorders” was observed in both databases which was primarily attributed to a higher

Misconception	Reality	Source
OTC Tadalafil is completely safe	Not entirely, side effects and interactions possible	MHRA, NHS
Only prescribed meds work	OTC can be effective if used responsibly	Medical advice
It can cure all ED causes	It alleviates symptoms, not cures underlying causes	Urology guidelines
It’s addictive	No evidence of physical dependence	Clinical studies

incidence of specific adverse events such as ‘Headache’, ‘Loss of consciousness’, ‘Syncope’, ‘Dizziness’ and ‘Subarachnoid haemorrhage’.

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In addition, potential changes in case characteristics over time are presented. For New Zealand, ICSRs retrieved from SMARS are additionally presented. Since October, 2014 in New Zealand, pharmacists are supplying Sildenafil for the treatment of ED without prescription. Number of ICSRs and reporting rates over time: The annual number of relevant ICSRs retrieved from EVDAS and FAERS, stratified by seriousness, are shown in Tables 7 and 8, respectively. There was no indication of a significant increase in the number of reports following the non-Rx/OTC switch in 2014.

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Because most cases in EVDAS and FAERS were reported before 2016 whereas annual sales data were available only from 2016 onwards, calculation of meaningful reporting rates was not possible (Table 7 and 8). Table 7: EVDAS, Sildenafil, New Zealand: Number of relevant ICSRs retrieved, by seriousness. Shaded row indicates the year of switch of prescription status. Table 8: FAERS, Sildenafil, New Zealand: Number of relevant ICSRs retrieved, by seriousness. There was no indication of a trend towards a greater proportion of serious or fatal cases in either database after the switch to nonprescription status. Review of the corresponding cases in FAERS revealed that most of the cases reported in or after 2018 were duplicates (16 of the 29 cases reporting Headache were duplicates,

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17 of the 23 cases reporting Syncope were duplicates, 16 of the 17 cases reporting Loss of consciousness were duplicates and 12 of the 21 cases reporting dizziness were duplicates).

Adverse effects

Patient age, reported in 26 cases retrieved from SMARS, ranged from 39 to 81 years (median, 63.5 years). No time trend in patient age was apparent. No contraindicated medicines were reported as concomitant or cosuspect drugs in any of the ED cases from New Zealand retrieved from any of the three databases. Sildenafil is available as non-prescription medicine for treatment of ED in Poland since May, 2016. Number of ICSRs and reporting rates over time: The annual number of relevant tadalafil weekend pill cases and corresponding annual reporting rates for ICSRs retrieved from EVDAS (stratified by seriousness) and from FAERS (stratified by duplicate classification) for 2014 to 2024, are shown in Figures 4 and 5, respectively.

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The trend towards increasing annual ICSR numbers coincided with an almost 5-fold increase in exposure between 2014 and 2023 (full year data is not available for year 2024, hence data of 2023 was taken for comparison). Consequently, exposure-adjusted reporting rates did not increase after the non-Rx/OTC switch in 2016. Increasing case numbers also need to be seen against the backdrop of a general increase in spontaneous ADR reporting observed in Europe. Moreover, for FAERS, more than half of the serious cases reported from Poland in recent years were determined to be probable case duplicates (Figures 4 and 5). Figure 4: EVDAS/Sildenafil/Poland – Number of ICSRs and reporting rates, by seriousness. This high proportion of duplicate reports suggests that the actual number of unique adverse events may be considerably lower than initially indicated by the raw data. Two of the 8 cases reporting ‘Subarachnoid haemorrhage’ were identified as probable duplicates of a case initially

Age Group	Percentage	Common Usage Reasons	Frequency of Use	Additional Notes
30-40	25%	Erectile Dysfunction	Occasionally	Active lifestyle
40-50	40%	Performance enhancement, ED	Regularly	Health-conscious
50-60	25%	Age-related ED	Occasionally	Medical oversight
60+	10%	Age-related health concerns	Rarely	Consult doctor

reported in 2009 and further 5 cases were probable duplicates of a single case occurring in 2019.

Dosage	Typical Use Cases	Max Daily Dose	Notes
5 mg	Mild ED, occasional use	20 mg	Start with lowest dose
10 mg	Moderate ED	20 mg	Standard OTC dose
20 mg	Severe ED, as advised by pharmacist	20 mg	Do not exceed recommended
25 mg (less common)	Specific formulations or as advised	25 mg	Less common, consult pharmacist

Since 2018, there has been a notable increase in Adverse Drug Reactions (ADRs) reported within the System Organ Class (SOC) of Vascular disorders from FAERS.

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A cluster of cases in FAERS (and SMARS) but not in EVDAS in 10mg tadalafil 2023 mostly comprised reports of perceived drug ineffectiveness in the ED indication. It is unclear why these cases were classified as serious in FAERS. The number of relevant ICSRs retrieved from SMARS and the corresponding reporting rates are presented in Table 9. Because sales data were only available for 2016-2024, annual reporting rates could only be calculated for the post non-Rx/OTC switch period. These rates were consistently <1 per 1 million sold tablets until 2019 and <2 per 1 million sold tablets in 2020 and 2023.

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Table 9: Sildenafil, New Zealand: Number of relevant ICSRs retrieved from SMARS and corresponding reporting rates. The majority of the ICSRs were reported in the year 2023 in which most frequently reported PT was Drug ineffective (n=5). No specific trend in adverse event reporting was observed. Case characteristics: The ADRs included in the ICSRs retrieved from EVDAS, FAERS and SMARS respectively. From the limited number of ICSRs reported, no noteworthy ADR clusters or trends over time were observed. This rise was attributed to reports of known undesirable effects, ‘Flushing’, ‘Orthostatic hypotension’, ‘Hypotension’ and ‘Hot flush’.

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Sildenafil is available as non-prescription medicine for treatment of ED in the UK since March, 2018. Number of ICSRs and reporting rates over time: Consistent with high exposure estimates for sildenafil in the UK as well as a traditionally high spontaneous ADR reporting rate, the majority of the ICSRs selected from EVDAS and FAERS (71.93% and 87.30%, respectively) were received from the UK (5). An increase in ICSR numbers over time was observed. This trend coincided with an approximately 75% increase in exposure between 2014 and 2022 and also needs to be seen against the backdrop of a general increase in spontaneous ADR reporting observed in Europe in recent years. Annual exposure-adjusted ICSR reporting rates were consistently very low (<4 to 5 ICSRs per million sold tablets per year) but showed a transient increase for non-serious cases in 2018- 2019 and increase for serious cases in 2023 (Figure 6).