Actisite
FDA Approves Dotarem, a New MRI Agent »
"The U.S. Food and Drug Administration today approved Dotarem (gadoterate meglumine) for use in magnetic resonance imaging (MRI) of the brain, spine and associated tissues of patients ages 2 years and older.
Dotarem is a gadolinium-based"...
Actisite
Please Note: This Brand Name drug is no longer available in the US.(Generic versions may still be available.)
Actisite Side Effects Center
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Actisite FDA Prescribing Information: Side Effects
(Adverse Reactions)
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.
Read the entire FDA prescribing information for Actisite (Tetracycline Periodontal) »
Additional Actisite Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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