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Arestin (Minocycline Hydrochloride) - Side Effects and Adverse Reactions

 
 



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 AEs543589987
   Periodontitis25.6%28.1%16.3%
   Tooth Disorder12.0%13.7%12.3%
   Tooth Caries9.2%11.2%9.9%
   Dental Pain8.8%8.8%9.9%
   Gingivitis7.2%8.8%9.2%
   Headache7.2%11.6%9.0%
   Infection8.0%9.6%7.6%
   Stomatitis8.4%6.8%6.4%
   Mouth Ulceration1.6%3.2%5.0%
   Flu Syndrome3.2%6.4%5.0%
   Pharyngitis3.2%1.6%4.3%
   Pain4.0%1.2%4.3%
   Dyspepsia2.0%04.0%
   Infection Dental4.0%3.6%3.8%
   Mucous Membrane Disorder2.4%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



See index of all Arestin side effect reports >>

Drug label data at the top of this Page last updated: 2007-04-24

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