Oracea

Oracea

Oracea Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Oracea (doxycycline) Capsules is an antibiotic used to treat several bacterial infections such as urinary tract infection, acne, gonorrhea, chlamydia, gum disease, and rosacea. It is available in generic form. Common side effects of Oracea include nausea, diarrhea, upset stomach, skin rash, itching, and vaginal discharge.

The recommended dosage of Oracea is one 40 mg capsule taken in the morning on an empty stomach. Oracea may interact with cholesterol lowering medication, Accutane, Renova, Retin-A, antacids, iron, zinc, calcium, magnesium, blood thinners, and penicillin antibiotics. Tell your doctor all medications and supplements you are taking. Ask your doctor about non-hormone methods of birth control you can use while taking Oracea. Drink plenty of liquids while taking Oracea. Children should not take this medication. Do not take Oracea if you are pregnant or breastfeeding.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Oracea in Detail - Patient Information: Side Effects

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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Oracea Overview - Patient Information: Side Effects

SIDE EFFECTS: Upset stomach, nausea, diarrhea, or mild headache may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: sunburn (sun sensitivity), difficult/painful swallowing, brown/gray tooth discoloration, blue/gray/brown discoloration of the skin/lips/tongue/gums, unusual tiredness, new signs of infection (e.g., fever, chills, persistent sore throat), change in the amount of urine, pink urine.

Tell your doctor immediately if any of these rare but very serious side effects occur: hearing changes (e.g., ringing in the ears, decreased hearing), easy bruising/bleeding, unusual/severe headache, vision changes (e.g., blurred vision), severe stomach/abdominal pain, persistent nausea/vomiting.

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection (fungal infections). Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, skin lesions/sores, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, new or worsening swelling/pain in the joints, swollen glands, chest pain, fast/irregular heartbeat.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Oracea (Doxycycline)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Oracea FDA Prescribing Information: Side Effects
(Adverse Reactions)

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 - User Reviews

Oracea User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Oracea sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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