Demeclocycline Side Effects

Please note - some side effects for Demeclocycline may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Demeclocycline - for the Consumer

Demeclocycline

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Demeclocycline:

Diarrhea; dizziness; headache; indigestion; loss of appetite; nausea; sensitivity to sunlight; throat irritation; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; blurred vision; dark urine; decreased or increased urination; fever, chills, or sore throat; increased thirst; muscle weakness; red, swollen, blistered, or peeling skin; severe diarrhea; severe or persistent headache; severe or persistent throat irritation; severe skin reaction to the sun; stomach pain or cramps; unusual bruising or bleeding; unusual tiredness; vaginal irritation or discharge; vision changes; weakness; yellowing of the skin or eyes.

Demeclocycline Side Effects - for the Professional

Demeclocycline

The following reactions have been reported in patients receiving tetracyclines:

Gastrointestinal: Anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, pancreatitis, and inflammatory lesions (with monilial overgrowth) in the anogenital region, increases in liver enzymes, and hepatic toxicity has been reported rarely.

Rarely, hepatitis and liver failure have been reported. These reactions have been caused by both the oral and parenteral administration of tetracyclines.

Instances of esophageal ulcerations have been reported in patients receiving oral tetracyclines. Most of the patients were reported to have taken the medication immediately before lying down.

Skin: Maculopapular and erythematous rashes, erythema multiforme. Exfoliative dermatitis has been reported but is uncommon. Fixed drug eruptions and Stevens-Johnson syndrome have been reported rarely. Lesions occurring on the glans penis have caused balanitis. Pigmentation of the skin and mucous membranes has also been reported. Photosensitivity is discussed above.

Renal toxicity: Acute renal failure. Rise in BUN has been reported and is apparently dose related. Nephrogenic diabetes insipidus.

Hypersensitivity reactions: Urticaria, angioneurotic edema, polyarthralgia, anaphylaxis, anaphylactoid purpura, pericarditis, exacerbation of systemic lupus erythematosus, lupus-like syndrome, pulmonary infiltrates with eosinophilia.

Hematologic: Hemolytic anemia, thrombocytopenia, neutropenia and eosinophilia have been reported.

CNS: Pseudotumor cerebri (benign intracranial hypertension) in adults and bulging fontanels in infants. Dizziness, headache, tinnitus, and visual disturbances have been reported. Myasthenic syndrome has been reported rarely.

Other: When given over prolonged periods, tetracyclines have been reported to produce brown-black microscopic discoloration of thyroid glands. No abnormalities of thyroid function studies are known to occur. Very rare cases of abnormal thyroid function have been reported.

Tooth discoloration has occurred in pediatric patients less than 8 years of age, and also has been reported rarely in adults.

Side Effects by Body System

Dermatologic

Phototoxic reactions appear to be more common with demeclocycline 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 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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