Oracea

What Is Oracea?

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.

What Are Side Effects of Oracea?

Common side effects of Oracea include:

• nausea,
• diarrhea,
• upset stomach,
• headache,
• skin rash,
• itching, and
• vaginal itching or discharge.

Dosage for Oracea

The recommended dosage of Oracea is one 40 mg capsule taken in the morning on an empty stomach.

What Drugs, Substances, or Supplements Interact with Oracea?

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.

Oracea During Pregnancy or Breastfeeding

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.

Additional Information

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.

 

Oracea Consumer Information

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, flu-like symptoms, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes. This reaction may occur several weeks after you began using doxycycline.

Call your doctor at once if you have:

• severe stomach pain, diarrhea that is watery or bloody;
• throat irritation, trouble swallowing;
• chest pain, irregular heart rhythm, feeling short of breath;
• little or no urination;
• low white blood cell counts--fever, chills, swollen glands, body aches, weakness, pale skin, easy bruising or bleeding;
• increased pressure inside the skull--severe headaches, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes; or
• signs of liver or pancreas problems--loss of appetite, upper stomach pain (that may spread to your back), tiredness, nausea or vomiting, fast heart rate, dark urine, jaundice (yellowing of the skin or eyes).

Common side effects may include:

• nausea, vomiting, upset stomach, loss of appetite;
• mild diarrhea;
• skin rash or itching;
• darkened skin color; 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.

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

Read the entire FDA prescribing information for Oracea (Doxycycline)