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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
|Subjects with any AE||99 (40.2)|
|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.
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].
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 Doryx (doxycycline hyclate) Side Effects Center for a complete guide to possible side effects
Antacids And Iron Preparations
Absorption of tetracyclines is impaired by antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate, and iron-containing preparations.
Concurrent use of tetracycline may render oral contraceptives less effective.
Barbiturates And anti-epileptics
Barbiturates, carbamazepine, and phenytoin decrease the half-life of doxycycline.
The concurrent use of tetracycline and Penthrane® (methoxyflurane) has been reported to result in fatal renal toxicity.
Drug/Laboratory Test Interactions
False elevations of urinary catecholamines may occur due to interference with the fluorescence test.
Read the Doryx Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 6/18/2015
This monograph has been modified to include the generic and brand name in many instances.
Additional Doryx Information
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