Sumycin Side Effects

Generic name: tetracycline

Generic Name: Tetracycline,tetracycline

Please note - some side effects for Sumycin 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 Sumycin - for the consumer

Sumycin

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 Sumycin:

Black hairy tongue; blurred vision; bulky loose stools; diarrhea; difficulty swallowing; fever; headache; hives; hoarseness; indigestion; inflammation or redness of tongue; joint pain; loss of appetite; mouth sores; nausea; rash; sensitivity to sunlight; sore throat; stomach pain; swelling and itching of the rectum.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); infection (fever, chills, sore throat); itching; nausea; severe skin reaction to the sun; vaginal irritation or discharge; vomiting.

Sumycin Suspension

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 Sumycin Suspension:

Black hairy tongue; bulky loose stools; diarrhea; difficulty swallowing; headache; hoarseness; indigestion; inflammation of the mouth; inflammation of the skin; inflammation or redness of tongue; joint pain; loss of appetite; mouth sores; nausea; sensitivity to sunlight; swelling and itching of the rectum; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision; bulging soft spot in the head of infants; increased pressure in the head; prolonged or severe diarrhea; prolonged or severe headache; purple patches under the skin; second infection (fever, chills, sore throat); severe skin reaction to the sun; stomach pain; vaginal irritation or discharge.

For the professional

Sumycin

Gastrointestinal

Anorexia, epigastric distress, nausea, vomiting, diarrhea, bulky loose stools, stomatitis, sore throat, glossitis, black hairy tongue, dysphagia, hoarseness, enterocolitis, and inflammatory lesions (with candidal overgrowth) in the anogenital region, including proctitis and pruritus ani. Rare instances of esophagitis and esophageal ulceration have been reported in patients receiving particularly the capsule and also the tablet forms of tetracyclines. Most of the patients were reported to have medication immediately before going to bed. These reactions have been caused by both the oral and parenteral administration of tetracyclines but are less frequent after parenteral use.

Skin and Skin Structures: maculopapular and erythematous rashes.

Exfoliative dermatitis has been reported but is uncommon. Onycholysis and discoloration of the nails have been reported rarely. Photosensitivity has occurred.

Renal Toxicity

Increases in BUN have been reported and are apparently dose-related.

Hepatic Cholestatis

Hepatic cholestatis has been reported rarely, and is usually associated with high dosage levels of tetracycline.

Hypersensitivity Reactions

Anaphylaxis; serum sickness-like reactions, as fever, rash, and arthralgia; urticaria, angioneurotic edema, anaphylactoid purpura, pericarditis, exacerbation of systemic lupus erythematosus.

Hematological

Blood: anemia, hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, neutropenia and eosinophilia have been reported.

Miscellaneous

Dizziness and headache have been reported.

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. Bulging fontanels in infants and intracranial hypertension in adults have been reported.

By body system

Gastrointestinal side effects

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.

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.

Renal side effects

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.

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.

Dermatologic side effects

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

Musculoskeletal side effects

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.

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 side effects

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

There have been several cases of benign intracranial hypertension (pseudotumor cerebri) associated with tetracycline 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.

Hematologic side effects

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.

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

Hypersensitivity side effects

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 side effects

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 side effects

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 side effects

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.

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.

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