Atridox

Side Effects & Drug Interactions

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SIDE EFFECTS

In clinical trials involving a total of 1436 patients, adverse experiences from all causalities were monitored across treatment groups.

In the Circulatory System category, 10 subjects (1.6%) in the ATRIDOX® group were reported as having "unspecified essential hypertension." Only 1 subject (0.2%) in the Vehicle group, and none in the Scaling and Root Planing or Oral Hygiene groups were reported to have "unspecified essential hypertension." In all cases, the event occurred anywhere from 13 to 134 days post treatment. There is no known association of oral administration of doxycycline with essential hypertension.

Two patients in the polymer vehicle group and none in the ATRIDOX® group (0.2% for both groups combined) reported adverse events consistent with a localized allergic response.

Sex, age, race and smoking status did not appear to be correlated with adverse events.

The following table lists the incidence of treatment-emergent adverse events from all causalities, across all treatment groups, occurring in ≥ 1% of the entire study population.

Body System Verbatim Terms	Doxycycline n=609	Vehicle n=413	OH n=204	SRP n=210
Circulatory
High blood pressure	1.6%	0.2%	0.0%	0.0%
Digestive
Gum discomfort, pain or soreness; loss of attachment; increased pocket depth	18.1%	23.0%	20.1%	21.0%
Toothache, pressure sensitivity	14.3%	14.3%	10.3%	18.1%
Periodontal abscess, exudate, infection, drainage, extreme mobility, suppuration	9.9%	10.9%	10.3%	8.6%
Thermal tooth sensitivity	7.7%	8.5%	4.4%	6.7%
Gum inflammation, swelling, sensitivity	4.1%	5.8%	5.4%	5.7%
Soft tissue erythema, sore mouth, unspecified pain	4.3%	5.3%	2.7%	6.2%
Indigestion, upset stomach, stomachache	3.6%	4.1%	2.9%	3.8%
Diarrhea	3.3%	2.4%	1.0%	1.0%
Tooth mobility, bone loss	2.0%	0.7%	0.5%	2.4%
Periapical abscess, lesion	1.5%	1.9%	1.0%	0.5%
Aphthous ulcer, canker sores	0.7%	1.7%	1.0%	1.4%
Fistula	0.8%	1.5%	1.5%	1.0%
Endodontic abscess, pulpitis	1.5%	1.5%	0.0%	0.5%
Jaw pain	1.1%	0.5%	1.0%	1.9%
Tooth loss	0.8%	1.5%	1.5%	0.0%
Bleeding gums	1.0%	0.7%	0.0%	2.4%
Genitourinary
Premenstrual tension syndrome	4.4%	3.1%	2.5%	3.3%
Ill-Defined Conditions
Headache	27.3%	28.1%	23.5%	23.8%
Cough	3.6%	6.1%	2.9%	2.4%
Sleeplessness	3.4%	1.5%	2.0%	2.9%
Body aches, soreness	1.6%	1.2%	1.5%	1.4%
Nausea and vomiting	1.8%	0.7%	2.5%	0.5%
Fever	1.0%	1.9%	1.0%	1.9%
Injury & Poisoning
Broken tooth	5.1%	4.1%	4.9%	5.7%
Mental
Tension headache	1.8%	0.7%	0.0%	1.0%
Musculoskeletal
Muscle aches	6.4%	4.6%	4.9%	3.3%
Backache	3.6%	5.3%	2.5%	6.2%
Pain in arms or legs	1.5%	2.2%	2.0%	2.4%
Lower back pain	1.6%	1.7%	0.5%	2.9%
Neck pain	1.3%	1.7%	1.0%	1.9%
Shoulder pain	1.0%	1.0%	1.5%	1.0%
Nervous System
Ear infection	1.6%	1.9%	2.0%	0.0%
Respiratory
Common cold	25.5%	25.2%	18.1%	6.7%
Flu, respiratory	6.1%	9.0%	3.9%	6.7%
Stuffy head, post nasal drip, congestion	5.6%	7.7%	2.9%	4.8%
Sore throat	5.7%	6.5%	2.0%	3.3%
Sinus infection	5.3%	2.7%	1.0%	1.9%
Flu	2.8%	2.9%	2.9%	3.3%
Bronchitis	2.3%	1.9%	1.5%	1.0%
Allergies	1.0%	1.0%	1.0%	1.9%
Skin & Subcutaneous Tissue
Skin infection or inflammation	1.3%	1.0%	1.0%	1.0%