Declomycin Side Effects

Generic name: demeclocycline

Note: This document contains side effect information about demeclocycline. Some of the dosage forms listed on this page may not apply to the brand name Declomycin.

Some side effects of Declomycin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to demeclocycline: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking demeclocycline (the active ingredient contained in Declomycin) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using demeclocycline and call your doctor at once if you have a serious side effect such as:

• fever, chills, body aches, flu symptoms;

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

• pale skin, dark colored urine, jaundice (yellowing of the skin or eyes);

• confusion, mood changes, weakness, increased thirst or urination;

• swelling, weight gain, urinating less than usual or not at all;

• chest pain, wheezing, dry cough, rapid breathing, feeling short of breath;

• severe tingling, numbness, pain, muscle weakness;

• headache, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes;

• sore throat and headache with a severe blistering, peeling, and red skin rash; or

• severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate.

Less serious side effects of demeclocycline may include:

• sores or swelling in your rectal or genital area;

• mild nausea, vomiting, diarrhea, loss of appetite;

• white patches or sores inside your mouth or on your lips;

• swollen tongue, trouble swallowing; 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.

For Healthcare Professionals

Applies to demeclocycline: oral tablet

Dermatologic

Phototoxic reactions appear to be more common with demeclocycline (the active ingredient contained in Declomycin) than with other tetracyclines. These reactions may reoccur up to 3 weeks after demeclocycline is discontinued. Patients receiving demeclocycline should avoid sun exposure and use sunscreen for about 3 weeks after completing demeclocycline therapy.

Dermatologic reactions associated with tetracyclines have included photosensitivity, maculopapular rash, erythematous rash, erythema multiforme, exfoliative dermatitis, fixed drug eruption, Stevens-Johnson syndrome, and skin and mucous membrane pigmentation.

Renal

Renal effects have included the inhibition of antidiuretic hormone (ADH) in the renal tubules. This action produces nephrogenic diabetes insipidus, resulting in polyuria and an inability to concentrate urine. Nephrogenic diabetes insipidus occurs at dosages between 600 to 1200 mg per day, generally after approximately 5 days of therapy, and reverses within approximately one week after therapy is discontinued. Tetracyclines have also been associated with acute renal failure and increased BUN.

Demeclocycline has been used to produce nephrogenic diabetes insipidus in patients with hyponatremia associated with the syndrome of inappropriate anti-diuretic hormone (SIADH) secretion. Demeclocycline use for this indication may be limited by increases in BUN and serum creatinine, which appear to be dose-related but are reversible when the drug is discontinued. Decreases in glomerular filtration rate and creatinine clearance, as well as azotemia, have been reported in patients with congestive heart failure, cirrhosis, and cancer treated with demeclocycline. Azotemia has been associated with increases in demeclocycline serum concentrations. In one report of three patients with cirrhosis, the decrease in inulin clearance associated with demeclocycline ranged from 63% to 78%.

Gastrointestinal

Gastrointestinal side effects associated with tetracyclines have included nausea, anorexia, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, pancreatitis, anogenital inflammation, and moniliasis. Esophageal ulceration has been reported in patients given demeclocycline (the active ingredient contained in Declomycin) without proper fluid when in a supine position. Tooth discoloration has been reported in pediatric patients and rarely in adults.

Nervous system

Nervous system side effects associated with tetracyclines have included dizziness, headache, tinnitus, visual disturbances, and pseudotumor cerebri.

Hypersensitivity

Hypersensitivity reactions associated with tetracyclines have included urticaria, angioneurotic edema, polyarthralgia, anaphylaxis, anaphylactoid purpura, pericarditis, exacerbation of systemic lupus erythematosus, lupus-like syndrome, and pulmonary infiltrations with eosinophilia.

Hematologic

Hematologic side effects associated with tetracyclines have included hemolytic anemia, thrombocytopenia, neutropenia, and eosinophilia.

Hepatic

Hepatic side effects associated with tetracyclines have included increased liver enzymes, hepatic toxicity, hepatitis, and liver failure.

Genitourinary

Genitourinary side effects associated with tetracyclines have included penile lesions and balanitis.

Other

The long-term use of tetracyclines has been associated with microscopic brown-black discoloration of the thyroid gland. Abnormal thyroid function has rarely been reported.

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