Actisite Side Effects

Generic name: tetracycline

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

Some side effects of Actisite 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 tetracycline: oral capsule, oral suspension, oral tablet

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

Stop using tetracycline and call your doctor at once if you have any of these serious side effects:

• severe headache, dizziness, blurred vision;

• fever, chills, body aches, flu symptoms;

• severe blistering, peeling, and red skin rash;

• urinating less than usual or not at all;

• pale or yellowed skin, dark colored urine, fever, confusion or weakness;

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

• loss of appetite, jaundice (yellowing of the skin or eyes); or

• easy bruising or bleeding, unusual weakness.

Less serious side effects of tetracycline may include:

• sores or swelling in your rectal or genital area;

• mild nausea, vomiting, diarrhea, or stomach upset;

• 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. Tell your doctor about any unusual or bothersome side effect.

For Healthcare Professionals

Applies to tetracycline: compounding powder, oral capsule, oral suspension, oral tablet

Gastrointestinal

Gastrointestinal side effects have included anogenital lesions with monilial overgrowth, anorexia, black hairy tongue, dysphagia, enamel hypoplasia, enterocolitis, epigastric distress, diarrhea, glossitis, nausea, permanent tooth discoloration, and vomiting. Rarely, esophageal ulceration has been reported with oral tablets and capsules.

There have been several cases of esophageal ulcers associated with oral tetracycline therapy. In each case, the patient had taken the medication just before bedtime with only small amounts of liquid and reported severe retrosternal pain and painful swallowing shortly thereafter. The ulcers resolved spontaneously after discontinuation of tetracycline therapy. To minimize esophageal irritation, patients should be advised to avoid taking tetracycline just before retiring and to take the medication with plenty of water.

Oral ulcers have also occurred in a patient who gargled with a tetracycline solution made by emptying the contents of a 250 mg capsule into water.

Renal

Renal side effects have included increased BUN and Fanconi's syndrome. In patients with preexisting renal impairment, tetracycline (the active ingredient contained in Actisite) may cause azotemia, hyperphosphatemia, and acidosis. Patients with dehydration are particularly vulnerable.

Renal side effects generally occurred in patients with preexisting renal disease and have been the result of accumulation of tetracycline. Increases in BUN commonly occur because of tetracycline's anti-anabolic effect but do not necessarily indicate renal dysfunction.

Fanconi's syndrome is characterized by renal glycosuria, phosphaturia, aminoaciduria, and acidosis with or without proteinuria and rickets. It is associated with the ingestion of outdated or degraded tetracycline. Additionally, previous formulations of tetracycline contained citric acid which may contribute to metabolic acidosis; however, current formulations of the drug do not. Patients generally require hospitalization with intravenous medication to correct the accompanying metabolic abnormalities. Most cases resolve over time after discontinuation of tetracycline without permanent sequelae. Patients should be instructed to discard any unused portions of tetracycline at the end of therapy and to never use tetracycline remaining from a previous prescription.

Dermatologic

Dermatologic side effects have included exfoliative dermatitis, maculopapular and erythematous rashes, nail discoloration, onycholysis, and photosensitivity.

Musculoskeletal

Tetracycline (the active ingredient contained in Actisite) deposits into calcium-rich developing osseous tissue thereby causing the discoloration of permanent teeth, decreased rate of enamel growth, and a decrease in linear skeletal growth rate.

Musculoskeletal side effects have included adult tooth discoloration, enamel hypoplasia, and a decrease in linear skeletal growth rate. Tetracycline should not be administered to pregnant women or children less than 12 years of age.

Nervous system

There have been several cases of benign intracranial hypertension (pseudotumor cerebri) associated with tetracycline (the active ingredient contained in Actisite) therapy. In most cases, the patient was female and was prescribed tetracycline to treat acne. Symptoms commonly occurring in these cases consisted of severe headaches, nausea, and blurred vision. Physical examination revealed papilledema in all cases, and several had significantly increased pressure on lumbar puncture. All patients recovered over time after discontinuation of tetracycline therapy. The mechanism for development of increased intracranial pressure is unknown.

Nervous system side effects have included benign intracranial hypertension (pseudotumor cerebri) in adults and bulging fontanels in infants.

Hematologic

At least two cases of tetracycline-induced hemolytic anemia have been reported. In both cases, the anemia resolved over time after discontinuation of the medication and reoccurred 1 to 2 years later following another course of tetracycline (the active ingredient contained in Actisite) therapy. The mechanism for development of hemolytic anemia is unknown.

Hematologic side effects have included hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, neutropenia, and eosinophilia.

Hypersensitivity

Hypersensitivity side effects have included urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, exacerbation of systemic lupus erythematosus, hypersensitivity myocarditis, and serum sickness-like reactions (fever, rash, arthralgia).

Hepatic

Hepatic side effects have included increased liver enzyme levels, hepatotoxicity, liver failure, and bile duct paucity with prolonged cholestasis. These may be dose-related.

Other

Other side effects have included superinfection due to overgrowth of resistant organisms. The long-term use of tetracyclines has been associated with microscopic brown-black discoloration of the thyroid gland; however, abnormal thyroid function has not been reported.

Metabolic

These metabolic side effects have occurred more commonly in the presence of preexisting renal disease, and occur as a result of the accumulation of tetracycline (the active ingredient contained in Actisite)

Metabolic side effects have included azotemia, hyperphosphatemia, and metabolic acidosis. Increases in serum BUN levels may occur as a result of the anti-anabolic action of tetracycline and not necessarily indicate renal disease.

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