Safety Profile
The safety of OraVerse® has been evaluated in 5 clinical trials involving 777 adults, adolescents and children. To date, over 4,500 dentists have purchased 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
- Pregnancy category C -- OraVerse has not been tested in pregnant women or nursing mothers.
- Adverse events for OraVerse were comparable to control in clinical trials
Frequency of Adverse Events in Pooled Studies
*Adverse reactions with frequency greater than or equal to 2% in either group.
OraVerse is indicated for reversal of soft-tissue anesthesia, i.e., anesthesia of the lip and tongue, and the associated functional deficits resulting from an intraoral submucosal injection of a local anesthetic containing a vasoconstrictor. OraVerse is not recommended for use in children less than 6 years of age or weighing less than 15 kg (33 lbs).
Important Safety Information
In clinical trials, the most common adverse events with OraVerse (phentolamine mesylate) vs. control were post procedural pain (6% vs. 6%), injection site pain (5% vs. 4%), tachycardia (5% vs. 6%), bradycardia (2% vs. 0.3%) and headache (3% vs. 4%). Following parenteral use of phentolamine in non-dental indications, 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 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.
