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No fatal cases were retrieved for Norway from either database since non-Rx switch (August, 2019).
| Age Range | Recommended Dosage | Frequency | Time Before Activity | Notes |
|---|---|---|---|---|
| 18-40 | 10mg | Once per day | 30-60 minutes | Take with water, avoid high-fat meals |
| 41-60 | 10mg or 20mg | Depending on response | 30-60 minutes | Consult doctor for adjustments |
| 60+ | 5mg or as prescribed | As advised | 30-60 minutes | Monitor side effects |
Case characteristics: The ADRs included in the ICSRs retrieved from EVDAS and FAERS. No noteworthy ADR clusters or trends over time were observed.
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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.
WIPO Domain Name Decision D2004-0794 for cialis-viagra.info, cialisapcalis.com (26 KB)
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 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. Patient age was reported for 17 of the 22 cases retrieved from FAERS and ranged from 31 to 81 years (median, 63 years).
- Ireland has strict regulations on online medication sales, including Cialis.
- Use secure websites ending with .ie or verified pharmaceutical platforms.
- Always read the instructions and contraindications before taking Cialis.
- Do not take Cialis with nitrates or certain other medications.
No contraindicated medicines were reported as concomitant or cosuspect drugs in any of the ED cases from Norway retrieved from either database.
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Cialis Generic | 20mg | 360 + 10 Pills | 427.34€ 406.99€ | |
| Cialis Generic | 20mg | 90 + 6 Pills | 154.71€ 147.34€ | |
| Cialis Generic | 20mg | 60 + 6 Pills | 117.76€ 112.15€ | |
| Cialis Generic | 5mg | 90 + 6 Pills | 115.91€ 110.39€ | |
| Cialis Generic | 60mg | 270 + 10 Pills | 443.96€ 422.82€ | |
| Cialis Generic | 60mg | 360 + 10 Pills | 570.52€ 543.35€ | |
| Cialis Generic | 60mg | 180 + 10 Pills | 313.11€ 298.20€ | |
| Cialis Generic | 10mg | 10 Pills | 31.41€ 29.91€ | |
| Cialis Professional | 40mg | 60 + 2 Pills | 262.32€ 249.83€ | |
| Cialis Generic | 2.5mg | 60 + 4 Pills | 83.43€ 79.46€ | |
| Cialis Professional | 40mg | 120 + 4 Pills | 436.68€ 415.89€ | |
| Cialis Soft Tabs | 20mg | 20 + 2 Pills | 66.98€ 63.79€ | |
| Cialis Super Active | 20mg | 10 Pills | 55.64€ 52.99€ | |
| Cialis Black | 80mg | 360 + 20 Pills | 639.78€ 609.31€ | |
| Cialis Original | 20mg | 120 + 8 Pills | 497.29€ 473.61€ |
Sildenafil is available as non-prescription medicine for treatment of ED in Ireland since January, 2021.
- Buying Cialis without a prescription is not legal in Ireland.
- Be wary of counterfeit Cialis when purchasing from unverified sources.
- Some Irish pharmacies offer online ordering for Cialis with consultation.
- Always check for authenticity and proper licensing of online pharmacies.
Number of ICSRs and reporting rates over time: The annual number of relevant cases and corresponding annual reporting rates for ICSRs retrieved from EVDAS, stratified by seriousness, are shown in Figure 10.
How this fits in
Further information on this case is not available. Of the other 3 ICSRs, one is a literature report where exposure to sildenafil predated the non-Rx/OTC switch and one is a published report from the Netherlands describing death primarily attributed to illicit use of 3-methylmethcathinone; both cases are thus unrelated to the non-Rx switch in the UK. In the remaining third article, radiological and clinical findings of HIV associated pneumonia and patient being a heavy smoker are risk factor for cardiac arrest leading to fatality. Patient age was reported for 541 of the 770 cases retrieved from FAERS and ranged from 22 to 91 years (median, 59 years). No contraindicated medicines were reported as concomitant or cosuspect drugs in any of the ED cases from the UK retrieved from either database. There was no increase in case numbers or reporting rates during the limited period since non-Rx switch in Ireland.
| Side Effect | Percentage of Users Reporting | Severity | Likelihood if Overused | Recommendations |
|---|---|---|---|---|
| Headache | 20% | Mild | Higher | Take with water |
| Muscle Pain | 10% | Mild to Moderate | Less likely | Monitor dosage |
| Flushing | 15% | Mild | Same | Avoid hot environments |
| Indigestion | 8% | Mild | Less likely | Take with food |
Figure 10: EVDAS/Sildenafil/Ireland – Number of ICSRs and reporting rates, by seriousness.
Dr. David Liu - PhD
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.
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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. Of the 17 cases retrieved for Ireland from FAERS for Ireland (Table 6), 4 cases were classified as probable duplicates.
Cialis® (tadalafil) marks 10 years since U.S. approval
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.
Study design
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 cialis tadalafil 20mg 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). In view of the low case numbers, ICSR reporting rates for cases retrieved from FAERS for Ireland were not calculated.
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Sildenafil is available as non-prescription medicine for treatment of ED in Norway since August, 2019. Number of ICSRs and reporting rates over time: ICSR numbers and reporting rates over time for cases retrieved from EVDAS and FAERS are shown in Figures 8 and 9, respectively. Based on small case numbers, a possible trend towards higher in case numbers in EVDAS is apparent; however, this trend started several years before the non-Rx switch in Norway and was mostly due to non-serious cases. Figure 8: EVDAS/Sildenafil/Norway – Number of ICSRs and reporting rates, by seriousness. Figure 9: FAERS/Sildenafil/Norway – Number of ICSRs and reporting rates, by duplicate classification. Case characteristics: The ADRs included in the ICSRs retrieved from EVDAS and FAERS respectively. From the limited number of ICSRs reported in EVDAS and FAERS, no noteworthy ADR clusters or trends over time were observed.
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In FAERS, 32 cases reported AE of Flushing, 15 cases reported orthostatic hypotension, 13 cases reported hypotension and 12 cases reported for hot flush. More than half of these above mentioned cases were probable duplicates. (22 out of 32 cases reporting Flushing were duplicates, 12 out of 15 cases reporting Orthostatic hypotension were duplicates, 9 out of 13 cases reporting Hypotension were duplicates and 9 out of 12 cases reporting Hot flush were duplicates). Review of a cluster of reports of ‘Cardiac arrest’ (14 ADRs cialis 10mg prescription in FAERS in 2021) revealed that 11 of these 14 cases are probable duplicates referring to the same patient. The case describes a lifethreatening suspected drug-drug interaction with an alpha receptor agonist and a beta blocker, which are listed drug interactions where particular caution is advised. Patient age was reported for 18 of the 20 cases retrieved from FAERS and ranged from 28 to 69 years (median, 59 years). No contraindicated medicines were reported as concomitant or cosuspect drugs in any of the ED cases from Ireland retrieved from either database.
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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). There was no indication of a trend towards a greater proportion of fatal cases after the switch to non-prescription status in either database. Figure 6: EVDAS/Sildenafil/UK – Number of ICSRs and reporting rates, by seriousness. Figure 7: FAERS/Sildenafil/UK – Number of ICSRs and reporting rates, by duplicate classification. 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 SOC “Nervous system disorders” was observed in both databases which was primarily attributed to a higher incidence of specific adverse events such as ‘Headache’, ‘Loss of consciousness’, ‘Syncope’, ‘Dizziness’ and ‘Subarachnoid haemorrhage’.
WIPO Domain Name Decision D2014-2202 for viagraindonesia.com (11 KB)
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, 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). 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 reported in 2009 and further 5 cases were probable duplicates of a single case occurring in 2019. 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. This rise was attributed to reports of known undesirable effects, ‘Flushing’, ‘Orthostatic hypotension’, ‘Hypotension’ and ‘Hot flush’. Tadalafil is available as OTC medicine for treatment of ED in Poland since March, 2022.
| Medication Name | Active Ingredient | Effectiveness Rank | Price (€) | Common Side Effects | Notes |
|---|---|---|---|---|---|
| Viagra | Sildenafil | High | 20-45 | Headache, flushing | Similar to Cialis, different onset time |
| Levitra | Vardenafil | Moderate | 25-40 | Dizziness, nasal congestion | Shorter duration |
| Stendra | Avanafil | High | 30-50 | Flushing, dizziness | Faster onset |