Recommended Topic Related To:

Actisite

"The U.S. Food and Drug Administration is alerting hospitals, health care professionals, and patients of a voluntary recall of all non-expired drug products produced and distributed for sterile use by Abrams Royal Compounding Pharmacy in Dallas, T"...

Actisite

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

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 Actisite (tetracycline periodontal) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

A A A

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.


Women's Health

Find out what women really need.

advertisement
advertisement
Use Pill Finder Find it Now See Interactions

Pill Identifier on RxList

  • quick, easy,
    pill identification

Find a Local Pharmacy

  • including 24 hour, pharmacies

Interaction Checker

  • Check potential drug interactions
Search the Medical Dictionary for Health Definitions & Medical Abbreviations