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Oracea (Doxycycline) - Side Effects and Adverse Reactions



Clinical Studies 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 (2)].

Skin: maculopapular and erythematous rashes. Exfoliative dermatitis has been reported but is uncommon. Photosensitivity is discussed above [see Warnings and Precautions (5.4)].

Renal toxicity: Rise in BUN has been reported and is apparently dose-related [see Warnings and Precautions (5.3)].

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 postapproval use of ORACEA.

• Nervous system: Pseudotumor ceribri (benign intracranial hypertension), headache


Below is a sample of reports where side effects / adverse reactions may be related to Oracea. The information is not vetted and should not be considered as verified clinical evidence.

Possible Oracea side effects / adverse reactions in 81 year old female

Reported by a individual with unspecified qualification from United States on 2011-12-22

Patient: 81 year old female

Reactions: Rash

Adverse event resulted in: hospitalization

Suspect drug(s):

Other drugs received by patient: Calcium Acetate

Possible Oracea side effects / adverse reactions in 51 year old female

Reported by a health professional (non-physician/pharmacist) from Sweden on 2012-01-31

Patient: 51 year old female

Reactions: LIP Swelling, Angioedema

Suspect drug(s):

Possible Oracea side effects / adverse reactions in 44 year old female

Reported by a physician from United States on 2012-02-18

Patient: 44 year old female

Reactions: Nausea, Dizziness, Facial Pain

Suspect drug(s):
Botox Cosmetic
    Dosage: 15 units, single
    Indication: Skin Wrinkling
    Start date: 2011-08-25
    End date: 2011-08-25

    Dosage: 40 mg, qd
    Administration route: Oral
    Indication: Acne
    End date: 2011-08-28

See index of all Oracea side effect reports >>

Drug label data at the top of this Page last updated: 2013-08-12

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