Medical Editor: John P. Cunha, DO, FACOEP
What Is Doxycycline Hyclate?
Doxycycline Hyclate Delayed-Release Tablets is a tetracycline-class antibiotic indicated for rickettsial infections, sexually transmitted infections, respiratory tract infections, specific bacterial infections, ophthalmic infections, anthrax (including inhalational anthrax, post-exposure), alternative treatment for selected infections when penicillin is contraindicated, adjunctive therapy in acute intestinal amebiasis and severe acne, and for prophylaxis of malaria. This medication is available in generic form.
What Are Side Effects of Doxycycline Hyclate?
Common side effects of doxycycline hyclate include:
- weight loss
- skin sensitivity to sunlight
- anemia, and
- vaginal yeast infection
Dosage for Doxycycline Hyclate
The usual adult dosage of doxycycline hyclate is 200 mg on the first day of treatment (administered 100 mg every 12 hours) followed by a maintenance dose of 100 mg daily. The pediatric dosage of doxycycline hyclate is based on the child's body weight.
What Drugs, Substances, or Supplements Interact with Doxycycline Hyclate?
Doxycycline hyclate may interact with anticoagulants, penicillin, antacids (containing aluminum, calcium, or magnesium), bismuth subsalicylate, iron-containing preparations, oral contraceptives, barbiturates, carbamazepine, phenytoin, and methoxyflurane. Tell your doctor all medications and supplements you use.
Doxycycline Hyclate During Pregnancy and Breastfeeding
Doxycycline hyclate is not recommended for use during pregnancy. Tetracycline-class drugs can cause fetal harm when administered to a pregnant woman. Doxycycline hyclate passes into breast milk. Breastfeeding while using doxycycline hyclate is not recommended.
Our Doxycycline Hyclate Delayed-Release Tablets 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.
Clinical Trial Experience
The safety and efficacy of Doxycycline Hyclate Delayed-Release Tablets, 200 mg as a single daily dose was evaluated in a multicenter, randomized, double-blind, active-controlled study. Doxycycline Hyclate Delayed-Release 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 Doxycycline Hyclate Delayed-Release Tablets, 200 mg treatment group and 132 (53.2%) subjects in the doxycyclinehyclate 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.
Table 1: Adverse Reactions Reported in Greater than or
Equal to 2% of Subjects
|Doxycycline Hyclate Delayed-Release Tablets, 200 mg
N = 246
|Preferred Term||n (%)|
|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 entire FDA prescribing information for Doxycycline Hyclate (Doxycycline Hyclate Delayed-release Tablets )