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Periochip

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Periochip

Periochip

Periochip Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

PerioChip (chlorhexidine gluconate) is an antimicrobial agent used to treat periodontitis in adults. Common side effects of PerioChip include toothache, upper respiratory tract infection, and headache.

Dosage of PerioChip is one chip inserted up to 5 mm into periodontal pocket. Up to 8 chips may be inserted in a single visit. Other drugs may interact with PerioChip. Tell your doctor all medications you are using and if you have dental crowns, veneers, or fillings. Use caution while taking PerioChip if you are pregnant or breastfeeding.

Our PerioChip (chlorhexidine gluconate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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 Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Periochip in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using chlorhexidine topical and call your doctor at once if you have a serious side effect such as:

  • severe burning, itching, or redness;
  • blistering or peeling;
  • swelling or severe skin rash; or
  • any other severe irritation of treated skin.

Less serious side effects may occur, and you may have none at all.

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.

Read the entire detailed patient monograph for Periochip (Chlorhexidine) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Periochip FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The most frequently observed adverse events in the two pivotal clinical trials were toothache, upper respiratory tract infection, and headache. Toothache was the only adverse reaction that was significantly higher (p = 0.042) in the PerioChip group when compared to placebo. Most oral pain or sensitivity occurred within the first week of the initial chip placement following SRP procedures, was mild to moderate in nature, and spontaneously resolved within days. These reactions were observed less frequently with subsequent chip placement at 3 and 6 months.

Table 3 lists adverse events, occurring in ≥ 1% of 225 patients that received PerioChip, pooled from the two pivotal clinic trials without regard to causality. Gingival bleeding was the only dental adverse event occurring at a rate of ≤ 1% in both groups.

Table 3 : Adverse events (frequency ≥ 1% for the PerioChip group) reported from 2 five-center U.S. clinical trials

  PerioChip Total
N = 225
Placebo Chip Total
N = 222
N % N %
All patients with Adverse Events 193 85.8 189 85.1
Toothache* 114 50.7 92 41.4
Upper resp tract infection 64 28.4 58 26.1
Headache 61 27.1 61 27.5
Sinusitis 31 13.8 29 13.1
Influenza-like-symptoms 17 7.6 21 9.5
Back pain 15 6.7 25 11.3
Tooth disorder** 14 6.2 15 6.8
Bronchitis 14 6.2 7 3.2
Abscess 13 5.8 13 5.9
Pain 11 4.9 11 5
Allergy 9 4 13 5.9
Myalgia 9 4 9 4.1
Gum hyperplasia 8 3.6 5 2.3
Pharyngitis 8 3.6 5 2.3
Arthralgia 7 3.1 13 5.9
Dysmenorrhea 7 3.1 13 5.9
Dyspepsia 7 3.1 6 2.7
Rhinitis 6 2.7 11 5
Coughing 6 2.7 7 3.2
Arthrosis 6 2.7 4 1.8
Hypertension 5 2.2 6 2.7
Stomatitis ulcerative 5 2.2 1 0.5
Tendinitis 5 2.2 1 0.5
*Includes dental, gingival or mouth pain, tenderness, aching, throbbing, soreness, discomfort, or sensitivity
** Includes broken, cracked or fractured teeth, mobile teeth, and lost bridges, crowns, or fillings

Read the entire FDA prescribing information for Periochip (Chlorhexidine) »

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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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