Arestin

Arestin Side Effects Center

Medical Editor: Charles Patrick Davis, MD, PhD

Arestin (minocycline hydrochloride) microspheres are indicated as an antibiotic adjunct to scaling and root planing (SRP) procedures for the reduction of periodontal pocket depth in adult patients with periodontal gum disease. There is no approved generic available. Common side effects from Arestin can include headache, infection, flu syndrome and pain.

Each unit dose contains the equivalent of 1 mg of minocycline in microspheres. Arestin is provided as a dry powder, packaged in a unit-dose cartridge, which is inserted into a cartridge handle to administer the product. The oral health care professional removes the disposable cartridge from its pouch and connects the cartridge to the handle mechanism. Arestin is a variable dose product, dependent on the size, shape, and number of pockets being treated. In US clinical trials, up to 122 unit-dose cartridges were used in a single visit and up to 3 treatments, at 3-month intervals, were administered in pockets with pocket depth of 5 mm or greater. Tetracycline antibiotic medications like Arestin pass through human breast milk. The potential for serious side effects in nursing infants is probable. Therefore, a decision should be made as to whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Caution, the use of this drug or drugs in the tetracycline class during tooth development during the last half of pregnancy, infancy and in children up to age 8 years may cause permanent tooth discoloration (yellow-gray to brown). The use of Arestin in the pediatric population has not been studied.

Our Arestin 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 Prescribing information?

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

Arestin FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The most frequently reported nondental treatment-emergent adverse events in the 3 multicenter US trials were headache, infection, flu syndrome, and pain.

Table 5: Adverse Events (AEs) Reported in ≥ 3% of the Combined Clinical

  SRP Alone
N=250
SRP + Vehicle
N=249
SRP + ARESTIN®
N=423
Number (%) of Patients
Treatment-emergent AEs
62.4% 71,9% 68.1%
Total Number of AEs 543 589 987
  Periodontitis 25.6% 28.1% 16.3%
  Tooth Disorder 12.0% 13.7% 12.3%
  Tooth Caries 9.2% 11.2% 9.9%
  Dental Pain 8.8% 8.8% 9.9%
  Gingivitis 7.2% 8.8% 9.2%
  Headache 7.2% 11,6% 9.0%
  Infection 8.0% 9.6% 7.6%
  Stomatitis 8.4% 6.8% 6.4%
  Mouth Ulceration 1.6% 3.2% 5.0%
  Flu Syndrome 3.2% 6.4% 5.0%
  Pharyngitis 3.2% 1.6% 4.3%
  Pain 4.0% 1.2% 4.3%
  Dyspepsia 2.0% 0 4.0%
  Infection Dental 4.0% 3.6% 3.8%
  Mucous Membrane Disorder 2.4% 0.8% 3.3%

Trial Population of 3 Multicenter US Trials by Treatment Group

The change in clinical attachment levels was similar across all study arms, suggesting that neither the vehicle nor ARESTIN® compromise clinical attachment.

Read the entire FDA prescribing information for Arestin (Minocycline Hydrochloride Microspheres) »

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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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