February 8, 2016
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Arestin

Side Effects
Interactions

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 Trial Population of 3 Multicenter US Trials by Treatment Group

  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%

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

Read the Arestin (minocycline hydrochloride microspheres) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

No information provided.

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 1/13/2016

Side Effects
Interactions

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