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Side Effects > Oracea

Oracea Side Effects

Generic Name: Doxycycline,doxycycline

Please note - some side effects for Oracea may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).


For the consumer

For the professional

Side Effects of Oracea - for the consumer


Oracea

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Oracea:

Diarrhea; nose or throat irritation; sensitivity to sunlight.

Seek medical attention right away if any of these SEVERE side effects occur when using Oracea:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue, unusual hoarseness); bloody stools; dark urine; decreased urination; fever, chills, or sore throat; severe diarrhea; severe or persistent headache; stomach pain or cramps; throat irritation; trouble swallowing; unusual bruising or bleeding; unusual tiredness; vaginal irritation or discharge; vision changes; yellowing of the skin or eyes.

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For the professional


Oracea

Adverse Reactions in Clinical Trials of Oracea

In controlled clinical trials of adult patients with mild to moderate rosacea, 537 patients received Oracea or placebo over a 16-week period. The most frequent adverse reactions occurring in these studies are listed in Table 3.

Table 3. Incidence (%) of Selected Adverse Reactions in Clinical Trials of Oracea (n=269) vs. Placebo (n=268)
  Oracea Placebo
Note: Percentages based on total number of study participants in each treatment group.
Nasopharyngitis 13 (4.8) 9 (3.4)
Pharyngolaryngeal Pain 3 (1.1) 2 (0.7)
Sinusitis 7 (2.6) 2 (0.7)
Nasal Congestion 4 (1.5) 2 (0.7)
Fungal Infection 5 (1.9) 1 (0.4)
Influenza 5 (1.9) 3 (1.1)
Diarrhea 12 (4.5) 7 (2.6)
Abdominal Pain Upper 5 (1.9) 1 (0.4)
Abdominal Distention 3 (1.1) 1 (0.4)
Abdominal Pain 3 (1.1) 1 (0.4)
Stomach Discomfort 3 (1.1) 2 (0.7)
Dry Mouth 3 (1.1) 0 (0)
Hypertension 8 (3.0) 2 (0.7)
Blood Pressure Increase 4 (1.5) 1 (0.4)
Aspartate Aminotransferase Increase 6 (2.2) 2 (0.7)
Blood Lactate Dehydrogenase Increase 4 (1.5) 1 (0.4)
Blood Glucose Increase 3 (1.1) 0 (0)
Anxiety 4 (1.5) 0 (0)
Pain 4 (1.5) 1 (0.4)
Back Pain 3 (1.1) 0 (0)
Sinus Headache 3 (1.1) 0 (0)

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..

Skin: maculopapular and erythematous rashes. Exfoliative dermatitis has been reported but is uncommon. Photosensitivity is discussed above..

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

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.

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MedFacts Periostat

MedFacts Oracea

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MedFacts Doryx Delayed-Release Capsules

MedFacts Doxycycline

Micromedex doxycycline - Includes detailed dosage instructions.

Micromedex Doxycycline - Includes detailed dosage instructions.

Micromedex Doryx - Includes detailed dosage instructions.

FDA Periostat

FDA Vibramycin

FDA Oracea

FDA Doxycycline

Facts & Comparisons Doxycycline

FDA Doryx

FDA Monodox

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