Oracea

Oracea

SIDE EFFECTS

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)

  ORACEA 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 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].

Skin: maculopapular and erythematous rashes. Exfoliative dermatitis has been reported but is uncommon. Photosensitivity is discussed above [see WARNINGS AND PRECAUTIONS].

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.

Postmarketing Experience

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.

Read the Oracea (doxycycline) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Anticoagulants

Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.

Penicillin

Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracycline-class drugs in conjunction with penicillin.

Methoxyflurane

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.

Oral Retinoids

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
This monograph has been modified to include the generic and brand name in many instances.

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Oracea - User Reviews

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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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