ADVERSE REACTIONS
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.
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REPORTS OF SUSPECTED ARESTIN SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Arestin. The information is not vetted and should not be considered as verified clinical evidence.
Possible Arestin side effects / adverse reactions in 31 year old male
Reported by a consumer/non-health professional from United States on 2011-11-11
Patient: 31 year old male
Reactions: Swelling Face, Tendon Rupture, Sunburn, Malaise, Arthralgia, Joint Swelling, Pericarditis, Insomnia, Chest Pain, Aortic Dilatation, Vision Blurred, Gait Disturbance, Feeling Abnormal
Adverse event resulted in: hospitalization
Suspect drug(s):
Arestin
Possible Arestin side effects / adverse reactions in 31 year old male
Reported by a consumer/non-health professional from United States on 2011-11-18
Patient: 31 year old male
Reactions: Swelling Face, Tendon Rupture, Sunburn, Malaise, Pericarditis, Arthralgia, Joint Swelling, Chest Pain, Insomnia, Vision Blurred, Aortic Dilatation, Gait Disturbance, Feeling Abnormal
Suspect drug(s):
Arestin
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