Minocycline Hydrochloride Microspheres
Name: Minocycline Hydrochloride Microspheres
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)
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