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U.S. Department of Health and Human Services

Safety

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Revatio (Sildenafil) Tablets, Oral Suspension and Injection

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – August 2012

Summary View

 

CONTRAINDICATIONS

  • Concomitant use of organic nitrates in any form, either regularly or intermittently, because of the greater risk of hypotension
  • Known hypersensitivity to Sildenafil or any component of the tablet, injection, or oral suspension. Hypersensitivity, including anaphylactic reaction, anaphylactic shock and anaphylactoid reaction, has been reported in association with the use of Sildenafil.
 

WARNINGS AND PRECAUTIONS

Hypotension
  • Revatio has vasodilatory properties, resulting in mild and transient decreases in blood pressure…
Visual Loss
  • When used to treat erectile dysfunction, non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported postmarketing in temporal association with the use of phosphodiesterase type 5 (PDE-5) inhibitors, including Sildenafil…
Hearing Loss
  • Cases of sudden decrease or loss of hearing, which may be accompanied by tinnitus and dizziness, have been reported in temporal association with the use of PDE-5 inhibitors, including Revatio…

 

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