Safety Profile
The safety of OraVerse® has been evaluated in 5 clinical trials involving 777 adults, adolescents and children. To date, over 3,000 dentists have purchased more than 130,000 cartridges of OraVerse. The adverse events reported since the introduction of OraVerse have been consistent with those seen in clinical trials.
OraVerse was well tolerated in clinical trials
- No contraindications
- No known drug interactions with OraVerse
- Phentolamine mesylate, the active ingredient in OraVerse, is a vasodilator used in medical indications since 1952.
- Adverse events for OraVerse were similar to control in clinical trials
Frequency of Adverse Events in Pooled Studies
*Adverse reactions with frequency greater than or equal to 3% in any OraVerse dose group and equal to or exceeding that of the control group.
OraVerse is indicated for use in adults and children 6 years of age or older and weighing at least 33 lbs.
Important Safety Information
Following parenteral use of phentolamine at doses between 5 and 15 times higher than the recommended dose of OraVerse (phentolamine mesylate), myocardial infarction and cerebrovascular spasm and occlusion have been reported, usually in association with marked hypotensive episodes producing shock-like states. Although such effects are uncommon with OraVerse, clinicians should be alert to the signs and symptoms of tachycardia, bradycardia, and cardiac arrhythmias, particularly in patients with a history of cardiovascular disease, as these symptoms may occur with the use of phentolamine or other alpha-adrenergic blocking agents. See full prescribing information for details.
