Drugs
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Sildenafil (marketed as Viagra and Revatio) Information
To report any serious adverse events associated with the use of this drug, please contact the FDA MedWatch program using the contact information at the bottom of this page.
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Related Information
FDA Drug Safety Communication: FDA recommends against use of Revatio (sildenafil) in children with pulmonary hypertension
8/30/2012Comunicado de la FDA sobre la seguridad de los medicamentos La FDA recomienda que no se use Revatio en niños con hipertensión pulmonar
8/30/2012FDA Drug Safety Podcast: FDA recommends against use of Revatio in children with pulmonary hypertension
8/30/2012Information for Healthcare Professionals: Sildenafil (marketed as Viagra and Revatio), Vardenafil (marketed as Levitra), Tadalafil (marketed as Cialis)
11/14/2007FDA Announces Revisions to Labels for Cialis, Levitra and Viagra
FDA news release (10/18/2007)Questions and Answers about Viagra, Levitra, Cialis, and Revatio: Possible Sudden Hearing Loss
10/2007FDA Updates Labeling for Viagra, Cialis and Levitra for Rare Post-Marketing Reports of Eye Problems
7/8/2005- Historical Information
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Regulatory History and Labeling from Drugs@FDA
- Regulatory History of Sildenafil
Includes labeling and approval letters
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