Doxycycline Side effects

• Side effects of Doxycycline in details
• Doxycycline contraindications
• Doxycycline reviews

What are the possible side effects of Doxycycline?

Get emergency medical help if you have any signs of an allergic reaction to Doxycycline: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• changes in your vision;

• severe stomach pain, diarrhea that is watery or bloody;

• fever, swollen glands, body aches, flu symptoms, weakness;

• skin rash, pale skin, easy bruising or bleeding, severe tingling, numbness, pain, muscle weakness;

• upper stomach pain (may spread to your back), loss of appetite, dark urine, jaundice (yellowing of the skin or eyes);

• chest pain, irregular heart rhythm, feeling short of breath;

• confusion, nausea and vomiting, swelling, rapid weight gain, little or no urinating;

• new or worsening cough with fever, trouble breathing;

• increased pressure inside the skull--severe headaches, ringing in your ears, dizziness, nausea, vision problems, pain behind your 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.

Common Doxycycline side effects may include:

• nausea, vomiting, upset stomach;

• mild diarrhea;

• 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.

Side effects of Doxycycline in details

Clinical Trial Experience

The safety and efficacy of Doxycycline Delayed-Release Tablets, 200 mg as a single daily dose was evaluated in a multicenter, randomized, double-blind, active-controlled study. Doxycycline Delayed-Release Tablets 200 mg was given orally once-a-day for 7 days and compared to Doxycycline 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 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

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.

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

Renal: Rise in BUN has been reported and is apparently dose-related.

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, pseudotumor cerebri) has been associated with the use of tetracycline

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.

What is the most important information I should know about Doxycycline?

• Be sure to use Doxycycline for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
• Doxycycline only works against bacteria; it does not treat viral infections (eg, the common cold).
• Long-term or repeated use of Doxycycline may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.
• If you are taking Doxycycline to prevent malaria, please note that no malaria medicine, including Doxycycline, guarantees protection against malaria. Stay in well-screened areas, use mosquito nets, cover the body with clothing, and use insect repellent to avoid being bitten by mosquitoes.
• Hormonal birth control (eg, birth control pills) may not work as well while you are using Doxycycline. To prevent pregnancy, use an extra form of birth control (eg, condoms).
• Doxycycline may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Doxycycline. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
• Mild diarrhea is common with antibiotic use. However, a more serious form of diarrhea (pseudomembranous colitis) may rarely occur. This may develop while you use the antibiotic or within several months after you stop using it. Contact your doctor right away if stomach pain or cramps, severe diarrhea, or blood stools occur. Do not treat diarrhea without first checking with your doctor.
• Do not take more than the recommended dose or take Doxycycline for longer than prescribed without checking with your doctor.
• Tell your doctor or dentist that you take Doxycycline before you receive any medical or dental care, emergency care, or surgery.
• Doxycycline may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Doxycycline.
• Lab tests, including liver function, kidney function, and complete blood cell counts, may be performed while you use Doxycycline. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Doxycycline with extreme caution in CHILDREN younger than 10 years old who have diarrhea or an infection of the stomach or bowel.
• Doxycycline should not be used in CHILDREN younger than 8 years old; permanent yellow-gray-brown tooth discoloration may occur.
• PREGNANCY and BREAST-FEEDING: Doxycycline has been shown to cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Doxycycline while you are pregnant. Doxycycline is found in breast milk. Do not breast-feed while taking Doxycycline.

Doxycycline contraindications

Do not use this medicine if you are pregnant. It could harm the unborn baby or cause permanent tooth discoloration later in life.

Doxycycline can make birth control pills less effective. Ask your doctor about using a non hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while using Doxycycline.

You should not take this medicine if you are allergic to Doxycycline or to other tetracycline antibiotics such as demeclocycline (Declomycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap).

Before taking Doxycycline, tell your doctor if you have liver disease, kidney disease, asthma, or if you are allergic to sulfites.

Drink plenty of liquids while you are taking Doxycycline.

Children should not use Doxycycline. Doxycycline can cause permanent yellowing or graying of the teeth in children younger than 8 years old.

Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics.

References

1. DailyMed. "DOXYCYCLINE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
2. European Chemicals Agency - ECHA. "Doxycycline Hyclate: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
3. HSDB. "DOXYCYCLINE". https://toxnet.nlm.nih.gov/cgi-bin/s... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology