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Together, these observations suggest that the case cluster seen in EVDAS for 2011 is due to delayed reporting of a batch of cases from earlier years (Table 3).

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

Table 3: Sildenafil, EVDAS: ICSRs by country and calendar year.

Tip	Explanation	Source
Check for authentic products	Only buy from reputable sources	NHS, MHRA notices
Be aware of side effects	Common and severe side effects, report if occurs	MHRA, BNF
Avoid alcohol and certain drugs	Can increase side effects or reduce efficacy	NHS, Pharmacist
Consult a healthcare professional before use	Especially if having existing health conditions	NHS, General Practitioners

Shaded cells indicate the year of switch of prescription status in the respective country. Because relevant variables for identification of case duplicates such as exact patient age or ADR onset date are not available in the EVDAS Level 1 retrievals, reliable identification of duplicate ICSRs was not possible within this dataset.

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ICSR review did however reveal case clusters suggestive for possible duplicates. FAERS: The query of FAERS resulted in a total of 47,238 ICSRs with FDA receipt date ≥01 Jan 2010, of which 1,414 originated from one of the countries of interest.

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Of these, 624 cases, concerning children, females and/or treatment of PAH, were excluded.

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The remaining 790 cases were included in the analysis (Figure 2).

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

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. The proportion of consumer cases ranged from 15% for Norway to 72% for New Zealand (Table 4).

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Table 4: Sildenafil, FAERS: ICSRs by reporter type and country.

Medical uses

The distribution of the 1,080 included cases by country and calendar year is shown in Table 3. Approximately one third of the cases (324/1,095 cases) were reported in 2011 alone. Further investigation of this cluster revealed that 239 of these 324 cases (27 serious, 212 non-serious) were reported into EV by a single marketing authorization holder over a 2-day period. No such cluster in 2011 was apparent in FAERS. A small subset of the serious cases could also be identified in FAERS, where they all had event onset dates and/or FDA receipt dates in 2009-2010. 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.

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Cialis Generic	5mg	20 Pills	41.99€ 39.99€	Buy
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Cialis Generic	60mg	60 + 4 Pills	145.06€ 138.15€	Buy
Cialis Generic	20mg	360 + 10 Pills	427.34€ 406.99€	Buy
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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.

Frequently Asked Question

ADR summary tabulations on MedDRA PT level were produced from the downloaded case listings and evaluated for any noteworthy trends in the distribution of ADRs over time that could indicate towards potential changes in the characteristics of the ICSRs received before and after the non-Rx/OTC switch. As possible indicators of change of patient characteristics or drug utilization over time, ICSRs were evaluated for changes of average patient age (FAERS only) and for evidence of concomitant use of contraindicated drugs (EVDAS, FAERS, SMARS and Sanofi CHC’s pharmacovigilance database; Appendix 3). Sildenafil is a medication primarily used to treat erectile dysfunction and pulmonary arterial hypertension. Sildenafil works by relaxing the muscles in the blood vessels of the penis, allowing increased blood flow during sexual stimulation, leading to an erection. EudraVigilance: The query of EVDAS resulted in a total of 29,752 ICSRs concerning sildenafil with an EV Gateway receipt date ≥01 Jan 2010, of which 1,472 originated from one of the countries of interest.

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Of these, 392 cases, concerning children, females and/or treatment of PAH, were excluded. The remaining 1,080 cases were included in the analysis (Figure 1). Figure 1: Flowchart of ICSRs retrieved from EVDAS. Consistent with high exposure estimates for sildenafil in the UK (Section 3.1.2.3) as well as traditionally high spontaneous ADR reporting rates in the UK, 763 (71%) of the 1,080 cases included in tadalafil in women the analysis were reported from the UK [5]. Further 153 cases (14%) were from Norway, 76 cases (7%) from Poland, 45 cases (4%) from Ireland and 43 cases (4%) from New Zealand.

Pregnancy Categories

The proportion of consumer cases ranged from 14% for Norway to 74% for New Zealand. 487 cases (45%) were serious, including 43 (4%) fatal cases. The proportion of serious cases ranged from 16% for Norway to 52% for UK (Table 1 and 2). Table 1: Sildenafil/EVDAS: ICSRs by reporter type and country. Table 2: Sildenafil/EVDAS: ICSRs by seriousness and country. Table 6: Sildenafil, FAERS: ICSRs by country and calendar year.

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Cases concerning tadalafil were included for further analysis only if they originated from Poland or the UK. ICSRs concerning females, patients younger than 18 years of age, or describing use of sildenafil or tadalafil in patients with PAH (as defined in Appendix 2) were excluded from all analyses. Within the FAERS dataset, almost half of the retrieved, relevant ICSRs were suggestive for duplicates (i.e., ICSRs reporting the same country of origin, patient age and sex, suspect and concomitant drugs, ADRs and/or ADR onset dates, but received from different marketing authorization holders and with different Worldwide Unique Case Identification Numbers). Because full case information was not accessible through the FAERS Public Dashboard, definitive identification of case duplicates was not possible. Therefore, suspected duplicates were not categorically excluded from the FAERS dataset.

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However, probable duplicates were flagged and the effect of excluding these cases on reporting patterns was explored in the country-specific analyses. In the EVDAS Level 1 retrievals, exact patient age and ADR onset dates are not provided at all, thereby prohibiting reliable identification of potential duplicates. There was no indication of the presence of duplicates in Sanofi CHC’s global pharmacovigilance database or, from the limited information available, in the SMARS dataset. Number of ICSRs and reporting rates over time The mode of dispensing of the suspect drug is not reported in the outputs of any of the queried databases and could also not be reliably established from the trade name of the suspect PDE5i, which was missing in approximately 52.5% of the relevant ICSRs of tadalafil retrieved from Sanofi CHC’s company database. Unknown delays between dispense, administration, ADR onset and ADR reporting also prohibited reliable classification of ICSRs as “prescription cases” vs.

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“non-Rx/OTC cases” based on ADR onset date or report date. Therefore, the annual number of ICSRs over time (i.e., pre and post non-Rx/OTC switch) was displayed and assessed per country, acknowledging that ICSRs reported after the non-Rx/OTC switch date would comprise an unknown mix of ADRs occurring in prescription and non-prescription settings. To crudely adjust for changes in patient exposure over time, country-specific, annual RR (number of ICSRs per million sold tablets) were calculated for Poland, UK, Norway and Ireland for 2014-2024 on the basis of IQVIA sales data. For New Zealand, sales data were only available for 2016-2024 (Appendix 4). These analyses were stratified by case seriousness (EVDAS and Sanofi CHC’s global pharmacovigilance database only) and duplicate classification (probable duplicate yes/no; FAERS only). SMARS: The query of the New Zealand SMARS database revealed 43 cases, 37 of which were deemed relevant for this analysis.

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At the time of data retrieval for this analysis, data were current through 01 May 2024. Sanofi Consumer Healthcare’s (CHC) pharmacovigilance database holds full case information for all ICSRs reported for Sanofi medicinal products from worldwide sources. ICSRs concerning sildenafil are not systematically collected in this database because Sanofi does not hold any marketing authorizations for sildenafil products. Currently, UK is the only country where Sanofi is marketing authorization holder and has launched a tadalafil product. In accordance with applicable regulatory requirements, ICSRs are entered into this database not only if they concern a Sanofi CHC product, but also if a Sanofi CHC product cannot be ruled out based on the reported information.

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Therefore, cases potentially concerning non-Sanofi CHC or not belonging to nonprescription tadalafil products might be stored in this database. The cut-off date for this database was 30 June, 2024. Data retrievals and selection of relevant ICSRs FAERS, EVDAS and SMARS were queried for ICSRs where sildenafil was reported as a suspect or interacting drug and that had been initially entered into the respective database on or after 01 Jan, 2010. This date was chosen to allow for retrieval of ICSRs occurring with prescribed medicine that could serve as a baseline for comparison with ICSRs reported after the non-Rx/OTC switch. FAERS, EVDAS were also queried for ICSRs concerning tadalafil based on the same criteria.

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Sanofi CHC’s global pharmacovigilance database was queried for any ICSRs concerning tadalafil as suspect drug. Data from FAERS, EVDAS and Sanofi CHC’s global pharmacovigilance database were downloaded as Microsoft Excel® files (ICSR line listings). The ISCR listing resulting from the SMARS website query was also transferred into Excel®. Excel® was used to organize, classify, tabulate and visualize retrieved ICSRs. In line with the research questions, retrieved cases concerning sildenafil were included for further analysis only if they originated from Ireland, New Zealand, Norway, Poland or the UK.