Doxycyclineside effects

Some of the most common adverse reactions (incidence >2% and more common than with placebo) are nasopharyngitis, sinusitis, diarrhea, hypertension and aspartate aminotransferase increase. To report SUSPECTED ADVERSE REACTIONS, contact Mayne Pharma at 1-844-825-8500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical

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: In controlled clinical trials of adult subjects with mild to moderate rosacea, 537 subjects received Doxycycline 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 (n=269) v.s. Placebo (n=268) Doxycycline Placebo Nasopharyngitis 13 9 Pharyngolaryngeal Pain 3 2 Sinusitis 7 2 Nasal Congestion 4 2 Fungal Infection 5 1 Influenza 5 3 Diarrhea 12 7 Abdominal Pain Upper 5 1 Abdominal Distention 3 1 Abdominal Pain 3 1 Stomach Discomfort 3 2 Dry Mouth 3 0 Hypertension 8 2 Blood Pressure Increase 4 1 Aspartate Aminotransferase Increase 6 2 Blood Lactate Dehydrogenase Increase 4 1 Blood Glucose Increase 3 0 Anxiety 4 0 Pain 4 1 Back Pain 3 0 Sinus Headache 3 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.

Renal toxicity: Rise in BUN has been reported and is apparently dose-related.

Skin: maculopapular and erythematous rashes. Exfoliative dermatitis. Photosensitivity is discussed above.

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

Blood: Hemolytic anemia, thrombocytopenia, neutropenia, and eosinophilia.

6.2 Postmarketing

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.

Nervous system: Pseudotumor cerebri (benign intracranial hypertension), headache.

Skin: fixed drug eruption Psychiatric: depression, anxiety, suicidal ideation, insomnia, abnormal dreams, hallucination