Periostat (Doxycycline Hyclate) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

Adverse Reactions in Clinical Trials of a bioequivalent form of doxycycline hyclate capsules

In clinical trials of adult patients with periodontal disease 213 patients received 20 mg BID over a 9 - 12 month period. The most frequent adverse reactions occurring in studies involving treatment with a bioequivalent form of doxycycline hyclate capsules or placebo are listed below:

Incidence (%) of Adverse Reactions in Clinical Trials of Doxycycline Hyclate Capsules, 20mg (Bioequivalent to Doxycycline Hyclate Tablets, 20mg) vs. Placebo

Adverse Reaction	Doxycycline Hyclate Capsules 20 mg BID (n=213)	Placebo (n=215)
Note: Percentages are based on total number of study participants in each treatment group.
Headache	55 (26%)	56 (26%)
Common Cold	47 (22%)	46 (21%)
Flu Symptoms	24 (11%)	40 (19%)
Tooth Ache	14 (7%)	28 (13%)
Periodontal Abscess	8 (4%)	21 (10%)
Tooth Disorder	13 (6%)	19 (9%)
Nausea	17 (8%)	12 (6%)
Sinusitis	7 (3%)	18 (8%)
Injury	11 (5%)	18 (8%)
Dyspepsia	13 (6%)	5 (2%)
Sore Throat	11 (5%)	13 (6%)
Joint Pain	12 (6%)	8 (4%)
Diarrhea	12 (6%)	8 (4%)
Sinus Congestion	11 (5%)	11 (5%)
Coughing	9 (4%)	11 (5%)
Sinus Headache	8 (4%)	8 (4%)
Rash	8 (4%)	6 (3%)
Back Pain	7 (3%)	8 (4%)
Back Ache	4 (2%)	9 (4%)
Menstrual Cramp	9 (4%)	5 (2%)
Acid Indigestion	8 (4%)	7 (3%)
Pain	8 (4%)	5 (2%)
Infection	4 (2%)	6 (3%)
Gum Pain	1 (<1%)	6 (3%)
Bronchitis	7 (3%)	5 (2%)
Muscle Pain	2 (1%)	6 (3%)

Adverse Reactions for Tetracyclines

The following adverse reactions have been observed in patients receiving tetracyclines:

Gastrointestinal: anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, and inflammatory lesions (with vaginal candidiasis) in the anogenital region. Hepatotoxicity has been reported rarely. Rare instances of esophagitis and esophageal ulcerations have been reported in patients receiving the capsule forms of the drugs in the tetracycline class. Most of these patients took medications immediately before going to bed. (See DOSAGE AND ADMINISTRATION Section).

Skin: maculopapular and erythematous rashes. Exfoliative dermatitis has been reported but is uncommon. Photosensitivity is discussed above. (See WARNINGS Section).

Renal toxicity: Rise in BUN has been reported and is apparently dose related. (See WARNINGS Section).

Hypersensitivity reactions: urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, serum sickness, pericarditis, and exacerbation of systemic lupus erythematosus.

Blood: Hemolytic anemia, thrombocytopenia, neutropenia, and eosinophilia have been reported.

REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO PERIOSTAT

Possible Periostat side effects / adverse reactions in 24 year old female

Reported by a individual with unspecified qualification from United Kingdom on 2007-02-23

Patient: 24 year old female weighing 63.0 kg (138.6 pounds)

Reactions: Dysphagia, Dyspepsia

Suspect drug(s):
Periostat

Other drugs received by patient: Microgynon Contraceptive

Possible Periostat side effects / adverse reactions in 56 year old male

Reported by a physician from United States on 2007-07-20

Patient: 56 year old male

Reactions: Vision Blurred, Visual Acuity Reduced, Pharmaceutical Product Complaint

Adverse event resulted in: disablity

Suspect drug(s):
Doxycycline
    Dosage: 20 mg, bid
    Indication: Dental Treatment

Periostat
    Dosage: 20 mg, bid
    Indication: Dental Treatment
    Start date: 2004-03-25

Other drugs received by patient: Aspirin

Possible Periostat side effects / adverse reactions in 47 year old male

Reported by a individual with unspecified qualification from United States on 2007-07-20

Patient: 47 year old male

Reactions: Syncope, Hypotension, Bradycardia, Hypertension, Asthenia

Adverse event resulted in: life threatening event

Suspect drug(s):
Periostat

Other drugs received by patient: Zyrtec