Some of the most common adverse reactions (incidence >2% and more common than with placebo) are nasopharyngitis, sinusitis, diarrhea, hypertension and aspartate aminotransferase increase. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Macleods Pharma USA, Inc. at 1-888-943-3210 or 1-855-926-3384 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions in Clinical Trials of Doxycycline Capsules: In controlled clinical trials of adult subjects with mild to moderate rosacea, 537 subjects received doxycycline capsules or placebo over a 16-week period.
The following table summarizes selected adverse reactions that occurred in the clinical trials at a rate of ≥ 1% for the active arm: Table 1. Incidence (%) of Selected Adverse Reactions in Clinical Trials of Doxycycline Capsules (n=269) vs. Placebo (n=268) Doxycycline Placebo Nasopharyngitis 13 (5) 9 (3) Pharyngolaryngeal Pain 3 (1) 2 (1) Sinusitis 7 (3) 2 (1) Nasal Congestion 4 (2) 2 (1) Fungal Infection 5 (2) 1 (0) Influenza 5 (2) 3 (1) Diarrhea 12 (5) 7 (3) Abdominal Pain Upper 5 (2) 1 (0) Abdominal Distention 3 (1) 1 (0) Abdominal Pain 3 (1) 1 (0) Stomach Discomfort 3 (1) 2 (1) Dry Mouth 3 (1) 0 (0) Hypertension 8 (3) 2 (1) Blood Pressure Increase 4 (2) 1 (0) Aspartate Aminotransferase Increase 6 (2) 2 (1) Blood Lactate Dehydrogenase Increase 4 (2) 1 (0) Blood Glucose Increase 3 (1) 0 (0) Anxiety 4 (2) 0 (0) Pain 4 (2) 1 (0) Back Pain 3 (1) 0 (0) Sinus Headache 3 (1) 0 (0) Note: Percentages 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 at higher, antimicrobial doses: Gastrointestinal: anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, and inflammatory lesions (with vaginal candidiasis) in the anogenital region. Hepatotoxicity, Esophagitis and esophageal ulcerations have been reported in patients receiving the capsule forms of the drugs in the tetracycline-class.
Most of the patients experiencing esophagitis and/or esophageal ulceration took their medication immediately before lying down [ see Dosage and Administration ( 2 ) ]. Renal toxicity: Rise in BUN has been reported and is apparently dose-related [see Warnings and Precautions ( 5.4 )]. Skin: maculopapular and erythematous rashes. Exfoliative dermatitis. Photosensitivity is discussed above [see Warnings and Precautions ( 5.5 )] .
Hypersensitivity reactions: urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, serum sickness, pericarditis, and exacerbation of systemic lupus erythematosus. Blood: Hemolytic anemia, thrombocytopenia, neutropenia, and eosinophilia.
6.2Postmarketing Adverse Reactions
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following adverse reactions have been identified during post approval use of doxycycline capsules. Nervous system: Pseudotumor cerebri (benign intracranial hypertension), headache. Skin: fixed drug eruption Psychiatric: depression, anxiety, suicidal ideation, insomnia, abnormal dreams, hallucination
