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 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 SIDE EFFECTS / ADVERSE REACTIONS RELATED TO ARESTIN

Possible Arestin side effects / adverse reactions in 72 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2007-04-03

Patient: 72 year old female

Reactions: Cerebrovascular Accident

Suspect drug(s):
Arestin

Possible Arestin side effects / adverse reactions in 52 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2007-05-18

Patient: 52 year old female weighing 54.4 kg (119.7 pounds)

Reactions: Hypersensitivity

Suspect drug(s):
Arestin

Possible Arestin side effects / adverse reactions in 72 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2007-05-23

Patient: 72 year old female

Reactions: Cerebrovascular Accident

Suspect drug(s):
Arestin