July 31, 2015
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Doryx

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Doryx




Doryx Side Effects Center

Medical Editor: Charles Patrick Davis, MD, PhD

Last reviewed on RxList 4/25/2012

Doryx (doxycycline hyclate) is a tetracycline antibiotic used to treat or prevent infections with bacteria either proven or strongly suspected to be susceptible to this drug. Doryx is used to treat many types of infections such as acne, plague, cholera, relapsing fever, anthrax, syphilis, and many others. Doryx is available in generic form, termed doxycycline hyclate and other generic names. Doryx is a slow-release drug. Common side effects of Doryx include nausea, vomiting, upset stomach, diarrhea, skin rash or itching, vaginal itching or discharge, and dizziness. Contact your doctor if you have serious side effects of Doryx including fever, bloody or watery diarrhea, fast heart rate, jaundice (yellowing of skin or eyes), or severe skin reaction.

Doryx is available in 75 and 100 mg strength tablets. The usual dose is 100 mg twice daily in adults on day one, then 100 mg daily. Doses in children (age 8 and above) is based on weight. Drugs in the tetracycline class may cause permanent discoloration of teeth (yellow-brown) if used in the last half of pregnancy, infancy to the age of eight years. Other serious side effects include swelling of the throat, face or tongue, GI overgrowth by Clostridium difficile, severe rash, fever, headache, and renal problems. There are no adequate and well-controlled studies on the use of doxycycline in pregnant women. Tetracyclines are excreted in human milk, however, the extent of absorption of tetracyclines including doxycycline, by the breastfed infant is not known.

Our Doryx 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.

Doryx 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 Doryx (Doxycycline Hyclate)

What is Patient Information Overview?

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

Doryx Overview - Patient Information: Side Effects

SIDE EFFECTS: Stomach upset, diarrhea, nausea, or vomiting may occur. If any of these effects persist or worsen, tell 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 right away if you have any serious side effects, including: sunburn (sun sensitivity), painful/difficult swallowing, change in the amount of urine.

Tetracycline drugs such as doxycycline may rarely cause a serious increase in pressure inside the skull (intracranial hypertension-IH). The risk of this side effect is greater for women of childbearing age who are overweight or who have had IH in the past. If IH develops, it usually goes away after doxycycline is stopped; however, there is a chance of permanent vision loss or blindness. Get medical help right away if you have: persistent/severe headache, vision changes (such as blurred/double vision, decreased vision, sudden blindness), 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. 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, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

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 Doryx (Doxycycline Hyclate)

What is Prescribing information?

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

Doryx FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Trial Experience

The safety and efficacy of DORYX Tablets, 200 mg as a single daily dose was evaluated in a multicenter, randomized, double-blind, active-controlled study. DORYX Tablets, 200 mg was given orally once-a-day for 7 days and compared to doxycycline hyclate capsules 100 mg given orally twice daily for 7 days for the treatment of men and women with uncomplicated urogenital C. trachomatis infection.

Adverse events in the Safety Population were reported by 99 (40.2%) subjects in the DORYX Tablets, 200 mg treatment group and 132 (53.2%) subjects in the doxycycline hyclate capsules reference treatment group. Most AEs were mild in intensity. The most commonly reported adverse events in both treatment groups were nausea, vomiting, diarrhea, and bacterial vaginitis,

Table 1: Adverse Reactions Reported in Greater than or Equal to 2% of Subjects

Preferred Term DORYX Tablets, 200 mg
N = 246
n (%)
Subjects with any AE 99 (40.2)
  Nausea 33 (13.4)
  Vomiting 20 (8.1)
  Headache 5 (2.0)
  Diarrhea 8 (3.3)
  Abdominal Pain Upper 5 (2.0)
  Vaginitis Bacterial 8 (3.3)
  Vulvovaginal Mycotic Infection 5 (2.0)

Because clinical trials are conducted under prescribed conditions, adverse reaction rates observed in the clinical trial may not always reflect the rates observed in practice.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of doxycycline. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate a causal relationship to drug exposure.

Due to oral doxycycline's virtually complete absorption, side effects to the lower bowel, particularly diarrhea, have been infrequent.

The following adverse reactions have been observed in patients receiving tetracyclines:

Gastrointestinal: Anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, and inflammatory lesions (with monilial overgrowth) in the anogenital region. Hepatotoxicity has been reported. These reactions have been caused by both the oral and parenteral administration of tetracyclines. Esophagitis and esophageal ulcerations have been reported in patients receiving capsule and tablet forms of drugs in the tetracycline-class. Most of these patients took medications immediately before going to bed [see DOSAGE AND ADMINISTRATION].

Skin: Maculopapular and erythematous rashes, Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, and erythema multiforme have been reported. Photosensitivity is discussed above [see WARNINGS AND PRECAUTIONS].

Renal: 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.

Intracranial Hypertension

Intracranial hypertension (IH, pseudomotor cerebri) has been associated with the use of tetracycline [see WARNINGS AND PRECAUTIONS].

Thyroid Gland Changes: When given over prolonged periods, tetracyclines have been reported to produce brown-black microscopic discoloration of thyroid glands. No abnormalities of thyroid function are known to occur.

Read the entire FDA prescribing information for Doryx (Doxycycline Hyclate)

Doryx - User Reviews

Doryx 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 Doryx 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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