Home  |  News  |  Sitemap  |  Contact Us  |  Login
Advertise With Us
Latest Notification
  • banner1
  • banner2
  • banner3
  • banner4
  • banner5
  • banner6
  • banner7
banner11 banner22 banner33 banner44 banner45 banner46 banner47

 Adverse Cases

Back Reported Adverse Drug Reaction Cases
Sildenafil - Three Years Experience

Sildenafil (Viagra) has now been available in Australia for over 3 years. During that time ADRAC has received 773 reports for sildenafil with it as the only suspected drug in 741. Most of these reports describe reactions that are relatively minor in nature and are consistent with the pharmacology of the drug and the adverse effects observed during clinical trials (see Table 1).

There have been, however, 20 reports describing myocardial infarction which included 4 with a fatal outcome. Nine of the 20 patients had established cardiovascular disease or diabetes, or were at high risk of cardiovascular disease, and one was taking concomitant nitrates. There have also been 26 other reports of chest pain and 10 other reports which described a fatal outcome: 6 sudden unexplained deaths, 2 strokes and 2 subarachnoid haemorrhages. The temporal relationship to the ingestion of sildenafil was often not reported and in only 23 of these 56 cases could it be inferred that the event occurred within 6 hours of the use of the drug.

Because ingestion of sildenafil occurs in the context of sexual intercourse and, in some cases, underlying coronary disease, the contribution of sildenafil to cardiac events is difficult to assess. Information on prior risk factors and accurate details on drug ingestion and timing of the adverse reaction are often lacking. Resolution of the role of sildenafil requires robust epidemiological studies, however a recent publication which shows no evidence for a higher incidence of fatal myocardial infarction or ischaemic heart disease among users of sildenafil provides some reassurance that sildenafil may not be a primary cause of cardiovascular events.1

Table 1
Most Commonly Reported Reactions with Sildenafil

Adverse Reaction

Number of Reports





Abnormal vision


Therapeutic inefficacy




Chest pain








Myocardial infarction


Abdominal pain






Prescribers are reminded that the drug is contraindicated in men for whom sexual intercourse is inadvisable such as those with severe cardiovascular disease, established cardiac failure and unstable angina pectoris. The possibility of undiagnosed cardiovascular disorders in men with erectile dysfunction should be considered before prescribing. Sildenafil has been shown to potentiate the hypotensive effects of both acute and chronic nitrate administration and, therefore, its coadministration with nitrates in any form, either regularly or intermittently, is contraindicated.

duloxetin urologie duloxetin dosis duloxetin hexal 30 mg
budesonid astma budesonid astrazeneca budesonid 32
  1. Shakir SAW, Wilton LV, Boshier A, Layton D, Heeley E. Cardiovascular events in users of sildenafil: results from first phase of prescription event monitoring in England. BMJ 2001; 322: 651-2.


» Home
» Latest Notification
» New Drugs
» Import of Drugs
» Drug Prices
» Legislations
» Applications Forms
» Quackwatch
» Forms & Fees
» Licence Conditions
» Schedules
» Health, Pharma. Policies & Reports
» Ayurvedic
» Govt. Bodies
» Information Centre
» Directory
» Alert
» Regulatory News
» Research News
» News in Hindi
» Login
» Contact Us

Copyright © DrugsControl.org - Jaipur, INDIA. All Rights Reserved   |   Disclaimer   |   Sitemap

Site last updated: December 30, 1899 at