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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)
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%)

Note: Percentages are based on total number of study participants in each treatment group.

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.