The distribution of the 790
Proper Use
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. cases across country and calendar
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Cialis Generic | 40mg | 60 + 6 Pills | 130.98€ 124.74€ | |
| Tadalista Super Active | 20mg | 20 + 4 Pills | 92.35€ 87.95€ | |
| Cialis Generic | 10mg | 270 + 10 Pills | 308.71€ 294.01€ | |
| Cialis Generic | 2.5mg | 90 + 6 Pills | 112.43€ 107.08€ | |
| Cialis Generic | 5mg | 20 Pills | 41.99€ 39.99€ | |
| Cialis Generic | 60mg | 360 + 10 Pills | 570.52€ 543.35€ | |
| Cialis Generic | 20mg | 30 + 4 Pills | 68.05€ 64.81€ | |
| Cialis Generic | 60mg | 90 + 6 Pills | 196.67€ 187.30€ | |
| Cialis Generic | 5mg | 60 + 4 Pills | 86.02€ 81.92€ | |
| Tadalista Super Active | 20mg | 270 + 30 Pills | 661.49€ 629.99€ | |
| Tadalista Super Active | 20mg | 120 + 16 Pills | 382.15€ 363.95€ | |
| Cialis Generic | 2.5mg | 10 Pills | 28.51€ 27.15€ | |
| Cialis Generic | 2.5mg | 30 + 4 Pills | 51.95€ 49.48€ | |
| Cialis Generic | 60mg | 10 Pills | 41.22€ 39.26€ | |
| Cialis Generic | 2.5mg | 360 + 10 Pills | 260.03€ 247.65€ | |
| Cialis Generic | 2.5mg | 270 + 10 Pills | 199.64€ 190.13€ | |
| Cialis Generic | 10mg | 60 + 6 Pills | 105.81€ 100.77€ |
year is shown in Table 6 (Table 5 and 6).
- Tadalafil’s OTC status is more common in some countries outside the UK.
- Buying tadalafil over the counter without a prescription is risky and illegal.
- International online pharmacies may claim OTC availability, but legality is doubtful.
- Counterfeit tadalafil can cause side effects or reduce efficacy.
- Always seek medical advice before starting tadalafil treatment.
Table 5: Sildenafil, FAERS: ICSRs
Mechanism of action
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. Therefore, cases potentially concerning non-Sanofi CHC or not belonging to nonprescription tadalafil products might be stored in this database.
Pregnancy Categories
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. Sanofi CHC’s global pharmacovigilance database was queried for any ICSRs concerning tadalafil as suspect drug.
Cialis for ED and BPH
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 tadalafil sale 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. Cases concerning tadalafil were included for further analysis only if they originated from Poland or the UK. by duplicate categorization and country.
- The UK does not recognize OTC availability of tadalafil as standard practice.
- Tadalafil should be used only under supervision for optimal safety.
- Many unverified online sources claiming OTC sales are misleading.
- Pharmacists are unable to supply tadalafil OTC due to legal restrictions.
- Always prioritize health and legality when considering tadalafil purchase.
Table 6: Sildenafil, FAERS: ICSRs
- There are no officially approved OTC tadalafil products in the UK pharmacy market.
- Online regulatory agencies monitor and penalize illegal sales.
- Discussing health concerns with a doctor ensures proper tadalafil use.
- Illegal OTC sales undermine safety, efficacy, and legal compliance.
- Tadalafil's side effects necessitate professional medical guidance.
by country and calendar year.
Over-the-Counter ED Medications: What’s available in the UK
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 tadacip 20 mg tadalafil 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. 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).
Cialis for erectile dysfunction (ED)
Table 3: Sildenafil, EVDAS: ICSRs by country and calendar year. 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. 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.
Alternatives for erectile dysfunction (ED)
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. SMARS: The query of the
| Medication Type | Interaction Effect | Recommended Action | Notes |
|---|---|---|---|
| Nitrates | Severe hypotension | Avoid concurrent use | Dangerous blood pressure drop |
| Alpha-blockers | Increased risk of hypotension | Consult healthcare provider | Adjust dosage accordingly |
| Other ED drugs | Increased side effects | Do not combine | Risk of severe adverse effects |
| CYP3A4 inhibitors | Increased plasma levels of tadalafil | Dose reduction required | Potential for toxicity |
New Zealand SMARS database revealed
| Side Effect | Frequency | Severity | Advice | Notes |
|---|---|---|---|---|
| Headache | Common | Mild | Take pain relief | Usually transient |
| Flushing | Common | Mild | Stay cool | Temporary |
| Indigestion | Uncommon | Mild | Avoid spicy foods | |
| Ear ringing | Rare | Mild | Seek medical help | Persistent symptoms |
43 cases, 37 of which
Warnings & Precautions
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. Of these, 392 cases, concerning children, females and/or treatment of PAH, were excluded.
Levitra Brand
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 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. The proportion of consumer cases ranged from 14% for Norway to 74% for New Zealand.
Can I buy Tadalafil over-the-counter?
487 cases tadalafil online (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. The distribution of the 1,080 included cases by country and calendar year is shown in Table 3. were deemed relevant for this analysis. Further information on data retrieved from SMARS
What pharmacists and patients need to know about the currently available non-prescription ED products?
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. However, probable duplicates were flagged and the effect of excluding these cases on reporting patterns was explored in the country-specific analyses.
What if I miss a dose?
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. “non-Rx/OTC cases” based on ADR onset date or report date.
What should I do if I miss a dose of tadalafil?
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). 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. is presented in below section (Figure 3).
- Tadalafil treats erectile dysfunction and benign prostatic hyperplasia.
- Over-the-counter availability varies by country; UK is strict.
- Unauthorized OTC sales often come from black market sources.
- Fake tadalafil products pose health risks due to unregulated ingredients.
- Always verify sources before purchasing tadalafil OTC in the UK.