Oracea Side Effects
Generic Name: 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).
Oracea Side Effects - 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.
| 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.
TopSide Effects by Body System
Gastrointestinal
Gastrointestinal side effects have included nausea, esophageal irritation, ulceration, epigastric burning, and black, hairy tongue. At least one case of adult tooth staining has been reported. Other gastrointestinal side effects associated with tetracyclines have included anorexia, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, and inflammatory lesions with monilial overgrowth in the anogenital region.
Numerous cases of esophageal ulceration have been reported. In most of the cases the patients had taken their medication at bedtime, usually without enough liquid. Patients often present with severe retrosternal pain and difficulty swallowing. Ulcerations generally resolve within a week after discontinuation of the medication. One case report describes severe hiccups of 4-day duration associated with esophagitis following the first dose of doxycycline.
Case reports of doxycycline causing Clostridium difficile have also been described.
Genitourinary
Genitourinary side effects have included vaginal candidiasis and vaginal itch.
Hypersensitivity
Hypersensitivity reactions have included urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, serum sickness, pericarditis, exfoliative dermatitis, and exacerbation of systemic lupus erythematosus.
Dermatologic
In a double-blinded study, doxycycline was found to be more phototoxic than minocycline and demeclocycline. Paresthesias of the body areas exposed to sunlight may be early signs of sunburn reactions.
A case report of a possible photoallergic reaction describes scaly erythema and vesicles on the face and neck associated with doxycycline administration. Upon rechallenge, a flare with erythema, itching and burning occurred in the same area.
Another case report was documented in Australian troops treated with doxycycline 100 mg daily for malaria prophylaxis while on deployment in East Timor, a group of islands within the Malaysian archipelago located close to the equator. Of the 135 troops, 22 exhibited phototoxic reactions to low dosages of doxycycline that resembled severe sunburn with erythematous plaques on the sun-exposed areas. The troops used a sunscreen containing oxybenzone.
An 11-year-old boy treated with doxycycline for brucellosis was evaluated for painless brown nail discoloration. Doxycycline was initiated for brucellosis but stopped when the boy developed photo sensitivity, but 15 days after the initiation of therapy brown nail discoloration developed . Other than the brown discoloration, the boy's physical condition was normal and the discoloration disappeared within one month.
Dermatologic side effects have included photosensitivity, maculopapular and erythematous rashes, exfoliative dermatitis, nail discoloration, and photo-onycholysis.
There is a case report of doxycycline induced nail discoloration.
Other
The long-term use of tetracyclines has been associated with microscopic brown-black discoloration of the thyroid gland. Abnormal thyroid function has not been reported.
Hematologic
Hematologic side effects have included hemolytic anemia, thrombocytopenia, neutropenia, and eosinophilia.
Nervous system
Intracranial hypertension resulting in significant loss of vision has been reported.
A 70-year-old female patient with no significant medical history suddenly developed a severe headache followed by vomiting about 15 minutes after the initial dose of doxycycline. The patient also experienced memory dysfunction; she could not remember the events of the afternoon prior to the doxycycline dose and could not retain the information after she was reminded. The incident lasted about 30 minutes and she was transported to the hospital for further evaluation. No further cause, such as intoxication or trauma, could be elicited. Once at the hospital, the patient was able to remember the events of the afternoon and could retain new information, but amnesia regarding the events of the 30 minutes following the onset of the headache persisted. The patient's laboratory results, CT scan, MRI scan, cerebrospinal fluid, and EEG showed no pathology. When the patient was discharged 2 days later, the amnesia for the 30 minutes continued. After elimination of other symptomatic causes, the amnesia was concluded to be due to the doxycycline because of the close relation of the doxycycline dose and the onset of symptoms.
Nervous system side effects have included phrenic nerve paralysis after sclerotherapy, and intracranial hypertension (pseudotumor cerebri). Headache, dizziness, drowsiness, and amnesia have also been reported.
Hepatic
Hepatic side effects have included individual reports of acute hepatocellular injury and cholestatic reactions associated with low-dose oral doxycycline.
Metabolic
Metabolic side effects have included hypoglycemia in a nondiabetic patient.
Renal
Renal side effects have included a dose-related rise in BUN.
Ocular
Ocular side effects have included diplopia, papilledema, and loss of vision associated with doxycycline-induced intracranial hypertension.
TopMore Oracea resources
- Oracea Consumer Overview
- Oracea Prescribing Information (FDA)
- Oracea Detailed Consumer Information (PDR)
- Oracea Advanced Consumer (Micromedex) - Includes Dosage Information
- Doxycycline Prescribing Information (FDA)
- Doxycycline Medfacts Consumer Leaflet (Wolters Kluwer)
- Doxycycline Professional Patient Advice (Wolters Kluwer)
- Adoxa Medfacts Consumer Leaflet (Wolters Kluwer)
- Doryx Prescribing Information (FDA)
- Doryx Detailed Consumer Information (PDR)
- Doryx Delayed-Release Capsules Medfacts Consumer Leaflet (Wolters Kluwer)
- Monodox Prescribing Information (FDA)
- Periostat Prescribing Information (FDA)
- Periostat Medfacts Consumer Leaflet (Wolters Kluwer)
- Vibra-Tabs Medfacts Consumer Leaflet (Wolters Kluwer)
- Vibramycin Prescribing Information (FDA)
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