Tobramycin Side Effects

Some side effects of tobramycin 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 tobramycin: inhalation solution

If you experience any of the following serious side effects, stop using tobramycin and seek emergency medical attention or notify your doctor immediately:

• an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);

• ringing in the ears or changes in hearing;

• dizziness;

• new or worsening respiratory problems or difficulty breathing;

• muscle weakness; or

• a rash.

If you experience any of the following less serious side effects, continue using tobramycin and talk to your doctor:

• changes in voice; or

• unpleasant taste or odor of the medication.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

For Healthcare Professionals

Applies to tobramycin: compounding powder, inhalation capsule, inhalation solution, injectable powder for injection, injectable solution, intravenous solution

Nervous system

Parenteral: Ototoxicity may have included loss of auditory or vestibular function secondary to cochlear hair cell damage. Partial or total auditory changes were irreversible and usually bilateral; deafness may have continued to develop after drug was stopped. Eighth-nerve impairment primarily occurred in patients with preexisting renal damage, with normal renal function treated for longer periods and/or at higher doses than recommended, who previously received an ototoxic agent, and who were dehydrated. Risk of drug-induced hearing loss increased with extent of exposure to high peak or high trough serum levels. Ototoxicity may be less likely when tobramycin serum trough levels are less than 2 mg/L after parenteral administration.

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.

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

Headache has been reported in patients using inhaled tobramycin with ciprofloxacin for non-cystic fibrosis bronchiectasis.

Very common (10% or more): TOBI(R): Headache (12%); TOBI(R) Podhaler(TM): Headache (11.4%), hypoacusis (10%)
Common (1% to 10%): TOBI(R): Tinnitus (2.4%); TOBI(R) Podhaler(TM): Tinnitus (1.9%), deafness including unilateral deafness (reported as mild to moderate hearing loss or increased hearing loss; 1%)
Uncommon (0.1% to 1%): TOBI(R): Deafness including unilateral deafness (reported as mild to moderate hearing loss or increased hearing loss; 0.5%)
Rare (less than 0.1%): Neuromuscular blockade
Frequency not reported: Parenteral: Neurotoxicity, eighth-nerve impairment (auditory and vestibular ototoxicity), cochlear hair cell damage, dizziness, vertigo, roaring in ears, hearing loss, numbness, skin tingling, muscle twitching, convulsions, headache; Inhalation: Transient tinnitus, tinnitus, hearing loss, headache, ototoxicity
Postmarketing reports: Inhalation: Hearing loss, tinnitus

Renal

Nephrotoxicity primarily occurred in patients with preexisting renal damage and in patients with normal renal function treated for longer periods and/or at higher doses than recommended. Predisposing factors also included advanced age, dehydration, and concomitant use of other potentially nephrotoxic drugs.

The overall incidence of aminoglycoside nephrotoxicity was 2% to 10%, and increased if tobramycin trough levels exceeded 2 mg/L. One study showed that hyperbilirubinemia in patients with biliary obstruction predisposed to aminoglycoside nephrotoxicity.

A 62-year-old female with multiple comorbidities, including chronic renal insufficiency, was started on inhaled tobramycin for healthcare-associated pneumonia. The patient continued inhaled tobramycin for 27 days, during which her serum creatinine gradually rose. After reaching a serum creatinine 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.

Rare (less than 0.1%): Inhalation: Acute renal failure
Frequency not reported: Parenteral: Nephrotoxicity (usually reversible), renal function changes, rising BUN, rising non-protein nitrogen, rising serum creatinine, oliguria, cylindruria, increased proteinuria

Respiratory

Decreased lung function included reported decreases in pulmonary function tests or decreased lung volume on chest radiograph associated with intercurrent illness or study drug administration.

Bronchospasm has been reported with nebulized tobramycin in cystic fibrosis patients. To help prevent bronchospasm, a bronchodilator should be used in conjunction with nebulized tobramycin. The preserved parenteral formulation has been associated with more bronchospasm than the preservative-free solution for inhalation.

Wheeze, cough, and dyspnea have been reported in patients using inhaled tobramycin with ciprofloxacin for non-cystic fibrosis bronchiectasis.

Very common (10% or more): Bethkis(R): Decreased forced expiratory volume (31%), rales (19%); TOBI(R): Cough (31.1%), lung disorder (including pulmonary or cystic fibrosis exacerbations; 30.1%), productive cough (19.6%), dyspnea (12.4%), hemoptysis (12.4%), oropharyngeal pain (10.5%); TOBI(R) Podhaler(TM): Cough (up to 48.8%), lung disorder (including pulmonary or cystic fibrosis exacerbations; 33.8%), productive cough (18.2%), dyspnea (15.6%), oropharyngeal pain (14%), dysphonia (up to 13.6%), hemoptysis (13%), pharyngolaryngeal pain (10.9%)
Common (1% to 10%): Bethkis(R): Dysphonia (6%), wheezing (5%), epistaxis (3%), pharyngolaryngeal pain (3%), bronchitis (3%), tonsillitis (2%); TOBI(R): Upper respiratory tract infection (8.6%), decreased pulmonary function test (8.1%), nasal congestion (7.2%), rales (6.2%), wheezing (6.2%), voice alteration/dysphonia (3.8%), chest discomfort (2.9%), throat irritation (1.9%), epistaxis (1.9%), decreased forced expiratory volume (1%), sputum discoloration; TOBI(R) Podhaler(TM): Nasal congestion (8.1%), rales (7.1%), wheezing (6.8%), upper respiratory tract infection (6.8%), decreased pulmonary function test (6.8%), chest discomfort (6.5%), throat irritation (4.5%), decreased forced expiratory volume (3.9%), epistaxis (2.6%), bronchospasm (1.6%)
Uncommon (0.1% to 1%): TOBI(R): Bronchospasm (0.5%), rhinitis, decreased lung function
Frequency not reported: Inhalation: Bronchospasm, wheeze, cough, dyspnea

Hypersensitivity

Rare (less than 0.1%): Parenteral: Serious allergic reactions (including anaphylaxis and dermatologic reactions), allergic-type reactions (including anaphylactic symptoms and life-threatening or less severe asthmatic episodes); hypersensitivity reactions (including eosinophilia, pruritus, fever, rash, exfoliative dermatitis)
Frequency not reported: Cross-sensitivity among aminoglycosides

Severe and sometimes fatal allergic reactions (including anaphylaxis and dermatologic reactions including exfoliative dermatitis, toxic epidermal necrolysis, erythema multiforme, and Stevens-Johnson syndrome) have been reported rarely.

The sodium metabisulfite preservative in some formulations may cause allergic-type reactions (including anaphylactic symptoms and life-threatening or less severe asthmatic episodes) in some susceptible patients.

Dermatologic

Common (1% to 10%): TOBI(R): Rash (2.4%); TOBI(R) Podhaler(TM): Rash (2.3%)
Rare (less than 0.1%): Parenteral: Exfoliative dermatitis, toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome; Contact dermatitis (at least 1 case)
Frequency not reported: Parenteral: Rash, itching, urticaria

Contact dermatitis in a patient using tobramycin-containing ear drops has been reported.

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

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.

Fatigue has been reported in patients using inhaled tobramycin with ciprofloxacin for non-cystic fibrosis bronchiectasis.

Very common (10% or more): TOBI(R): Pyrexia (12.4%); TOBI(R) Podhaler(TM): Pyrexia (15.6%)
Uncommon (0.1% to 1%): TOBI(R): Malaise
Frequency not reported: Parenteral: Fever; Inhalation: Toxic trough levels, fatigue

Gastrointestinal

Common (1% to 10%): Bethkis(R): Diarrhea (2%); TOBI(R): Nausea (9.6%), vomiting (5.7%), diarrhea (1.9%); TOBI(R) Podhaler(TM): Nausea (7.5%), vomiting (6.2%), diarrhea (4.2%), dysgeusia (up to 6.5%)
Uncommon (0.1% to 1%): TOBI(R): Dysgeusia (0.5%)
Frequency not reported: Parenteral: Nausea, vomiting, diarrhea, Clostridium difficile associated diarrhea; Inhalation: Nausea

Nausea has been reported in patients using inhaled tobramycin with ciprofloxacin for non-cystic fibrosis bronchiectasis.

Hematologic

Common (1% to 10%): Bethkis(R): Increased red blood cell sedimentation rate (8%), eosinophilia (2%)
Frequency not reported: Parenteral: Anemia, granulocytopenia, thrombocytopenia, leukopenia, leukocytosis, eosinophilia

Metabolic

Common (1% to 10%): TOBI(R) Podhaler(TM): Increased blood glucose (2.9%)
Uncommon (0.1% to 1%): TOBI(R): Increased blood glucose (0.5%)
Rare (less than 0.1%): Clinical tetany
Frequency not reported: Parenteral: Increased serum lactate dehydrogenase, decreased serum calcium, decreased serum magnesium, decreased serum sodium, decreased serum potassium; Hypophosphatemia

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

Musculoskeletal

Common (1% to 10%): TOBI(R): Musculoskeletal chest pain (4.8%); TOBI(R) Podhaler(TM): Musculoskeletal chest pain (4.5%)

Hepatic

Rare (less than 0.1%): Parenteral: Elevated liver function tests, hepatotoxicity
Frequency not reported: Parenteral: Increased serum transaminases (AST, ALT), increased serum bilirubin

Immunologic

Common (1% to 10%): Bethkis(R): Increased immunoglobulins (2%)

Psychiatric

Rare (less than 0.1%): Delirium
Frequency not reported: Parenteral: Lethargy, mental confusion, disorientation

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.

Local

Frequency not reported: Parenteral: Pain at injection site

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