Nebcin Side Effects

Generic Name: tobramycin

Please note - some side effects for Nebcin 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 Nebcin - for the Consumer

Nebcin

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 Nebcin:

Diarrhea; headache; nausea; pain, swelling, or redness at the injection site; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); clumsiness; confusion; decreased hearing; decreased urination; dizziness or lightheadedness; feeling of a whirling motion; fever; hearing loss; itching; muscle weakness; numbness or tingling; ringing or roaring in the ears; seizures; unusual bruising or bleeding; vaginal irritation or discharge.

Side Effects by Body System

General

Ototoxicity and nephrotoxicity may be more common and more severe in patients with renal insufficiency.

The most frequent and serious adverse side effects of systemically administered tobramycin are ototoxicity and nephrotoxicity. Both ototoxicity and nephrotoxicity have been associated with elevated serum drug levels.

Tobramycin nebulizer solution is generally well tolerated, with transient voice alteration (reported in 13% of patients vs 7% with placebo) and tinnitus (3% of patients vs 0% with placebo) being reported significantly more often than with placebo. Patients experiencing tinnitus should be carefully monitored for high frequency hearing loss.

Nervous system

Nervous system side effects associated with parenteral therapy have included ototoxicity, which may be loss of auditory or vestibular function secondary to cochlear hair cell damage and may be irreversible. Transient tinnitus, tinnitus, and hearing loss have been reported in patients receiving tobramycin via inhalation. Tinnitus may be a sentinel symptom of ototoxicity. Some patients who concurrently received, or previously had prolonged therapy with, parenteral aminoglycosides reported hearing loss. Headache has been reported in patients using inhaled tobramycin with ciprofloxacin for non-cystic fibrosis bronchiectasis.

Ototoxicity may be less likely when tobramycin serum trough levels are less than 2 mg/L after parenteral administration.

Rare neurologic side effects include neuromuscular blockade, particularly in patients who are predisposed, including patients with myasthenia gravis, hypocalcemia, and those receiving a neuromuscular blocking agent.

A rare case of delirium has been reported in a patient who was receiving tobramycin, but there was concomitant opiate administration and underlying infection, which makes implication of tobramycin difficult.

Renal

The overall incidence of aminoglycoside nephrotoxicity is 2% to 10%, and increases if tobramycin trough levels exceed 2 mg/L. One study has shown that hyperbilirubinemia in patients with biliary obstruction predisposes to aminoglycoside nephrotoxicity.

A 62-year-old female with multiple comorbidities, including chronic renal insufficiency, was started on inhaled tobramycin for health care-associated pneumonia. The patient continued inhaled tobramycin for 27 days, during which her serum creatinine (SCr) gradually rose. After reaching a SCr level of 4.5 mg/dL, the inhaled tobramycin was discontinued on day 28 and the patient was started on hemodialysis due to acute renal failure.

Renal side effects have included nephrotoxicity, which occurs in 2% to 10% of patients. Predisposing factors include advanced age, preexisting renal insufficiency, dehydration, and concomitant use of other potentially nephrotoxic drugs. Acute renal failure has rarely been reported with inhaled tobramycin.

Metabolic

Metabolic side effects associated with parenteral tobramycin therapy have included hypokalemia, hypophosphatemia, and hypomagnesemia with resultant hypocalcemia.

Renal tubular toxicity may result in renal magnesium wasting, which may result in hypocalcemia (due to magnesium-dependent parathormone secretion) and clinical tetany in rare cases.

Hepatic

Hepatic side effects have included rare cases of elevated liver function tests and hepatotoxicity during parenteral tobramycin therapy.

Hypersensitivity

A case of erythroderma followed by exfoliative dermatitis was associated with intravenous and intraperitoneal tobramycin.

Hypersensitivity reactions have included rare cases of eosinophilia, pruritus, fever, and rash, including exfoliative dermatitis. Contact dermatitis in a patient using tobramycin-containing ear drops has been reported.

Respiratory

Respiratory side effects associated with nebulized tobramycin have included reports of bronchospasm in cystic fibrosis patients. To help prevent bronchospasm, a bronchodilator should be used in conjunction with nebulized tobramycin. Wheeze, cough, and dyspnea have been reported in patients using inhaled tobramycin with ciprofloxacin for non-cystic fibrosis bronchiectasis. The preserved parenteral formulation has been associated with more bronchospasm than the preservative-free solution for inhalation.

Other

Toxic trough levels have been reported with nebulized tobramycin administered by positive pressure ventilation to a patient with renal dysfunction. No symptoms of toxicity were noted.

Other

Other side effects have included reports of fatigue in patients using inhaled tobramycin with ciprofloxacin for non-cystic fibrosis bronchiectasis.

Gastrointestinal

Gastrointestinal side effects have included reports of nausea in patients using inhaled tobramycin with ciprofloxacin for non-cystic fibrosis bronchiectasis.

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