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 ORACEA
In controlled clinical trials of adult subjects with mild to moderate rosacea, 537 subjects received ORACEA 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 ORACEA (n=269) vs. Placebo (n=268)
|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 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 the patients experiencing esophagitis and/or esophageal ulceration took their medication immediately before lying down [see DOSAGE AND ADMINISTRATION].
Renal toxicity: Rise in BUN has been reported and is apparently dose-related [see WARNINGS AND PRECAUTIONS]. 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.
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 ORACEA.
- Nervous system: Pseudotumor cerebri (benign intracranial hypertension), headache.
Read the Oracea (doxycycline) Side Effects Center for a complete guide to possible side effects
The concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity.
Antacids and Iron Preparations
Absorption of tetracyclines is impaired by bismuth subsalicylate, proton pump inhibitors, antacids containing aluminum, calcium or magnesium and iron-containing preparations.
Low Dose Oral Contraceptives
Doxycycline may interfere with the effectiveness of low dose oral contraceptives. To avoid contraceptive failure, females are advised to use a second form of contraceptive during treatment with doxycycline.
There have been reports of pseudotumor cerebri (benign intracranial hypertension) associated with the concomitant use of isotretinoin and tetracyclines. Since both oral retinoids, including isotretinoin and acitretin, and the tetracyclines, primarily minocycline, can cause increased intracranial pressure, the concurrent use of an oral retinoid and a tetracycline should be avoided.
Barbiturates and Anti-epileptics
Barbiturates, carbamazepine, and phenytoin decrease the half-life of doxycycline.
Drug/Laboratory Test Interactions
False elevations of urinary catecholamine levels may occur due to interference with the fluorescence test.
Read the Oracea Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 8/12/2013
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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