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Arestin

Last reviewed on RxList: 5/22/2017
Arestin Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 05/23/2017

Arestin (minocycline hydrochloride) microspheres are indicated as an antibiotic add-on to scaling and root planing (SRP) procedures for the reduction of periodontal pocket depth in adult patients with periodontal gum disease. Common side effects of Arestin include:

  • headache,
  • infection,
  • flu-like symptoms,
  • pain,
  • mouth irritation,
  • gum infection,
  • cavities,
  • dental pain,
  • gum inflammation (gingivitis),
  • swelling and sores inside the mouth,
  • sore throat, and
  • indigestion.

Arestin is a variable dose product, dependent on the size, shape, and number of pockets being treated. Arestin may interact with other drugs. Tell your doctor all medications and supplements you use. Use of tetracycline antibiotic medications such as Arestin during tooth development may cause permanent discoloration of the teeth, and should not be used in children or in pregnant or nursing women.

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.

Arestin Professional Information

SIDE EFFECTS

The most frequently reported non-dental 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 Trial Population of 3 Multicenter US Trials by Treatment Group

  SRP Alone
N=250
SRP+ Vehicle
N=249
SRP+ ARESTIN®
N=423
Number (%) of Subjects 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%

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

To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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

Related Resources for Arestin

© Arestin Patient Information is supplied by Cerner Multum, Inc. and Arestin Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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