ACTISITE SIDE EFFECTS
- Generic Name: tetracycline periodontal
- Brand Name: Actisite
- Drug Class: Tetracyclines
Last updated on MDtodate: 10/03/2022
SIDE EFFECTS
Actisite (tetracycline periodontal) fiber has been studied in 1437 patients distributed as follows over pivotal, controlled, and open- label studies.
| Study Type | ||||
| Demographics | Pivotal | Controlled | Uncontrolled | TOTAL |
| Gender: | ||||
| Male | 113 | 70 | 455 | 638 |
| Female | 113 | 55 | 631 | 799 |
| Age Range | 25-88 | 25-73 | 13-87 | 13-88 |
| Race: | ||||
| Black | 13 | 12 | 41 | 66 |
| Asian | 4 | 1 | 10 | 15 |
| Hispanic | 3 | 3 | 11 | 17 |
| Caucasian | 206 | 105 | 964 | 1275 |
| Native American | 0 | 2 | 56 | 58 |
| Other | 0 | 2 | 5 | 7 |
The most frequently reported adverse reactions in the 226 patients in the pivotal clinical trials were discomfort on fiber placement (10%) and local erythema following removal (11%).
In controlled and open-label trials patients, the following adverse reactions have been reported in less than 1% of patients: oral candidiasis, glossitis, possible allergic response, staining of the tongue, severe gingival inflammation, throbbing pain, pain following placement in an abscessed area, and minor throat irritation.
SRC: NLM .