In clinical trials, the most common adverse reaction with OraVerse that was greater than the control group was injection site pain.
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Dental patients were administered a dose of either 0.2, 0.4 or 0.8 mg of OraVerse. The majority of adverse reactions were mild and resolved within 48 hours. There were no serious adverse reactions and no discontinuations due to adverse reactions.
Table 1 lists adverse reactions where the frequency was greater than or equal to 3% in any OraVerse dose group and was equal to or exceeded that of the control group.
Table 1: Adverse Reactions with Frequency Greater Than or Equal to 3% and Equal to or Exceeding Control
| Adverse Event || || OraVerse || || || Control |
| || 0.2 mg |
(N = 83)
| 0.4 mg |
(N = 284)
| 0.8 mg |
(N = 51)
| Total |
(N = 418)
| Total |
(N = 359)
| || N (%) || N (%) || N (%) || N (%) || N (%) |
|Patients with AEs||15 (18)||82 (29)||20 (39)||117 (28)||96 (27)|
| Tachycardia||0 (0)||17 (6)||2 (4)||19 (5)||20 (6)|
| Bradycardia||0 (0)||5 (2)||2 (4)||7 (2)||1 (0.3)|
| Injection site pain||5 (6)||15 (5)||2 (4)||22 (5)||14 (4)|
| Post procedural pain||3 (4)||17 (6)||5 (10)||25 (6)||23 (6)|
| Headache||0 (0)||10 (4)||3 (6)||13 (3)||14 (4)|
An examination of population subgroups did not reveal a differential adverse reaction incidence on the basis of age, gender, or race.
Results from the pain assessments in Study 1 and Study 2, involving mandibular and maxillary procedures, respectively, indicated that the majority of dental patients in both OraVerse and control groups experienced no or mild oral pain, with less than 10% of patients in each group reporting moderate oral pain with a similar distribution between the OraVerse and control groups. No patient experienced severe pain in these studies.
Adverse Reactions in Clinical Trials
Adverse reactions reported by less than 3% but at least 2 dental patients receiving OraVerse and occurring at a greater incidence than those receiving control, included diarrhea, facial swelling, increased blood pressure/hypertension, injection site reactions, jaw pain, oral pain, paresthesia, pruritus, tenderness, upper abdominal pain and vomiting. The majority of these adverse reactions were mild and resolved within 48 hours. The few reports of paresthesia were mild and transient and resolved during the same time period.
Post Marketing Adverse Reaction Reports from Literature and Other Sources
The following adverse reactions have been identified during postapproval parenteral use of phentolamine mesylate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Acute and prolonged hypotensive episodes and cardiac arrhythmias have been reported with the use of phentolamine. In addition, weakness, dizziness, flushing, orthostatic hypotension, and nasal stuffiness have occurred.