ADVERSE REACTIONS
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. (see DOSAGE AND ADMINISTRATION section).
Skin: maculopapular and erythematous rashes. Exfoliative dermatitis has been reported but is uncommon. Photosensitivity is discussed above. (see WARNINGS section).
Renal toxicity: Rise in BUN has been reported and is apparently dose-related. (see WARNINGS section).
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.
|
