Actisite Side Effects
Generic Name: tetracycline
Note: This page contains information about the side effects of tetracycline. Some of the dosage forms included on this document may not apply to the brand name Actisite.
For the Consumer
Applies to tetracycline: capsule, capsule delayed release, capsule extended release, powder for suspension, suspension, syrup, tablet, tablet delayed release, tablet extended release
Other dosage forms:
In addition to its needed effects, some unwanted effects may be caused by tetracycline (the active ingredient contained in Actisite). In the event that any of these side effects do occur, they may require medical attention.
If any of the following side effects occur while taking tetracycline, check with your doctor or nurse as soon as possible:For all tetracyclinesMore common:
- Increased sensitivity of skin to sunlight (rare with minocycline)
- Abdominal pain
- bulging fontanel (soft spot on head) of infants
- loss of appetite
- nausea and vomiting
- visual changes
- yellowing skin
- Greatly increased frequency of urination or amount of urine
- increased thirst
- unusual tiredness or weakness
- Pigmentation (darker color or discoloration) of skin and mucous membranes
Minor Side Effects
Some of the side effects that can occur with tetracycline may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:For all tetracyclinesMore common:
- Cramps or burning of the stomach
- Itching of the rectal or genital (sex organ) areas
- sore mouth or tongue
- Dizziness, light-headedness, or unsteadiness
In some patients tetracyclines may cause the tongue to become darkened or discolored. This effect is only temporary and will go away when you Stop taking tetracycline.
For Healthcare Professionals
Applies to tetracycline: compounding powder, oral capsule, oral suspension, oral tablet
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.[Ref]
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.[Ref]
Renal side effects generally occurred in patients with preexisting renal disease and have been the result of accumulation of tetracycline (the active ingredient contained in Actisite) 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.[Ref]
Renal side effects have included increased BUN and Fanconi's syndrome. In patients with preexisting renal impairment, tetracycline may cause azotemia, hyperphosphatemia, and acidosis. Patients with dehydration are particularly vulnerable.[Ref]
Dermatologic side effects have included exfoliative dermatitis, maculopapular and erythematous rashes, nail discoloration, onycholysis, and photosensitivity.[Ref]
Musculoskeletal side effects have included adult tooth discoloration, enamel hypoplasia, and a decrease in linear skeletal growth rate. Tetracycline (the active ingredient contained in Actisite) should not be administered to pregnant women or children less than 12 years of age.[Ref]
Tetracycline 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.[Ref]
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.[Ref]
Nervous system side effects have included benign intracranial hypertension (pseudotumor cerebri) in adults and bulging fontanels in infants.[Ref]
Hematologic side effects have included hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, neutropenia, and eosinophilia.[Ref]
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 therapy. The mechanism for development of hemolytic anemia is unknown.[Ref]
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).[Ref]
Hepatic side effects have included increased liver enzyme levels, hepatotoxicity, liver failure, and bile duct paucity with prolonged cholestasis. These may be dose-related.[Ref]
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.[Ref]
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 (the active ingredient contained in Actisite) and not necessarily indicate renal disease.[Ref]
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.[Ref]
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22. Kounis GN, Kouni SA, Chiladakis JA, Kounis NG "Comment: Mesalamine-Associated Hypersensitivity Myocarditis in Ulcerative Colitis and the Kounis Syndrome (February)." Ann Pharmacother 43 (2009): 393-4
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24. Frimpter GW, Timpanelli AE, Eisenmenger WJ, et al "Reversible fanconi syndrome caused by degraded tetracycline." JAMA 184 (1963): 111-3
Not all side effects for Actisite may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
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