Olvion Adverse Reactions

The adverse events were generally transient and mild to moderate in nature.
In fixed-dose studies, the incidence of some adverse events increased with dose.
The nature of the adverse events in flexible-dose studies, which more closely reflect the recommended dosage regimen, was similar to that for fixed-dose studies.
The most commonly reported adverse reactions were headache and flushing. (See Tables 1 and 2.)

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At doses above the recommended dose range, adverse events were similar to those detailed above but generally were reported more frequently.
In an analysis of double blind placebo controlled clinical trials encompassing >700 person-years of observation on placebo and >1300 person-years on sildenafil, there were no differences in the incidence rate of myocardial infarction (MI) or in the rate of cardiovascular mortality for patients receiving sildenafil compared to those receiving placebo. The rates of MI were 1.1 per 100 person-years for men receiving sildenafil and for those receiving placebo. The rates of cardiovascular mortality were 0.3 per 100 person-years for men receiving sildenafil and those receiving placebo.
The Following Adverse Reactions were Reported During Post-Marketing Surveillance: Immune System Disorders: Hypersensitivity reaction (including skin rash).
Nervous System Disorders: Seizure, seizure recurrence.
Cardiac Disorders: Tachycardia.
Vascular Disorders: Hypotension, syncope, epistaxis.
Gastrointestinal Disorders: Vomiting.
Eye Disorders: Eye pain, red eyes/bloodshot eyes.
Reproductive System and Breast Disorders: Prolonged erection and/or priapism.