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.
|
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
|
