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Oracea

Last reviewed on RxList: 1/25/2017
Oracea Side Effects Center

Last reviewed on RxList 11/22/2016

Oracea (doxycycline) Capsules is an antibiotic used to treat several bacterial infections such as urinary tract infection, acne, gonorrhea, chlamydia, gum disease, and rosacea. Oracea is available in generic form. Common side effects of Oracea include:

The recommended dosage of Oracea is one 40 mg capsule taken in the morning on an empty stomach. Oracea may interact with cholesterol lowering medications, Isotretinoin, tretinoin, antacids, products that contain bismuth subsalicylate such as Pepto-Bismol, minerals (such as iron, zinc, calcium, magnesium, and over-the-counter vitamin and mineral supplements), blood thinners, and penicillin antibiotics. Tell your doctor all medications and supplements you are taking. Do not use Oracea if you are pregnant; it could harm the fetus or cause permanent tooth discoloration later in life. Tell your doctor if you become pregnant during treatment with Oracea. Oracea can make birth control pills less effective. Ask your doctor about using non-hormonal birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while using Oracea. Oracea passes into breast milk and may affect bone and tooth development in a nursing baby. Breastfeeding while taking Oracea is not recommended.

Our Oracea (doxycycline) Capsules Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Oracea Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • severe headache, dizziness, blurred vision;
  • fever, chills, body aches, flu symptoms, swollen glands, rash or itching, joint pain, or general ill feeling;
  • urinating less than usual or not at all;
  • diarrhea that is watery or bloody
  • pale or yellowed skin, dark colored urine, fever, confusion or weakness;
  • severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
  • loss of appetite, jaundice (yellowing of the skin or eyes); or
  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects may include:

  • mild nausea, mild diarrhea;
  • upset stomach;
  • mild skin rash or itching; or
  • vaginal itching or discharge.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Oracea (Doxycycline)

Oracea Professional Information

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 entire FDA prescribing information for Oracea (Doxycycline)

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© Oracea Patient Information is supplied by Cerner Multum, Inc. and Oracea Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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