Tobramycin Side Effects

Medically reviewed by Drugs.com. Last updated on Nov 30, 2024.

Applies to tobramycin: inhalation capsule, inhalation solution.

Other dosage forms:

• injection solution

Precautions

It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Check with your doctor right away if you have dizziness, feeling of fullness in the ears, loss of balance, loss of hearing, ringing or buzzing in the ears, or trouble in hearing. These may be symptoms of a serious hearing or balance problem.

Your doctor may want to test your hearing while you are being treated with tobramycin. Tell your doctor if you already have hearing problems before you are given this medicine.

Using this medicine may cause harm to your kidneys. Check with your doctor right away if you or your child has blood in the urine, change in the frequency of urination, difficulty in breathing, increased thirst, swelling of the feet or lower legs, or weakness.

When you breathe in this medicine, you may have cough or trouble breathing. Call your doctor right away if you have a cough, trouble breathing, or chest tightness after using this medicine.

If any of your medicines do not seem to be working as well as usual, call your doctor right away. Do not change your doses or stop using your medicines without asking your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of tobramycin

Along with its needed effects, tobramycin may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking tobramycin:

Get emergency help immediately if any of the following symptoms of overdose occur while taking tobramycin:

Symptoms of overdose

• blue lips, fingernails, or skin
• dizziness or lightheadedness
• drowsiness
• feeling of constant movement of self or surroundings
• irregular, fast or slow, or shallow breathing
• sensation of spinning

Other side effects of tobramycin

Some side effects of tobramycin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For healthcare professionals

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

General adverse events

Inhalation Capsules: The most commonly reported side effects included cough, lung disorder, productive cough, and dyspnea.

Inhalation/nebulizer solution: The most commonly reported side effects included increased cough, pharyngitis, fever, and increased sputum.

Parenteral formulations: The most commonly reported serious side effects included hypersensitivity reactions, ototoxicity, and nephrotoxicity.^[Ref]

Respiratory

Inhalation Capsules:

• Very common (10% or more): Cough (up to 48.4%), lung disorder (up to 33.8%), productive cough (up to 18.2%), dyspnea (up to 15.6%), oropharyngeal pain (up to 14%), dysphonia (up to 13.6%), hemoptysis (up to 13%), pharyngolaryngeal pain (up to 10.9%)
• Common (1% to 10%): Bronchospasm, epistaxis, forced expiratory volume (FEV1) decreased, nasal congestion, pulmonary function test decreased, rales, throat irritation, upper respiratory tract infection, wheezing
• Frequency not reported: Cystic fibrosis exacerbation, pulmonary exacerbation, sputum discolored

Inhalation/nebulizer solution:

• Very common (10% or more): Cough increased (up to 50%), pharyngitis (up to 48%), sputum increased (up to 44%), dyspnea (up to 42%), rhinitis (up to 38%), lung disorder (up to 34%), cough (up to 31.1%), hemoptysis (up to 28%), lung function decreased (up to 29%), asthma (up to 28%), sputum discoloration (up to 25%), productive cough (up to 19.6%), sinusitis (up to 14%), upper respiratory tract infection (up to 14%), voice alteration (up to 13%), oropharyngeal pain (up to 10.5%)
• Common (1% to 10%): Dysphonia, epistaxis, FEV1 decreased, hyperventilation, hypoxia, laryngitis, lower respiratory tract infection, nasal congestion, nasal polyp, pulmonary function test decreased, rales, respiratory disorder, throat irritation, wheezing
• Rare (0.01% to 0.1%): Bronchospasm
• Frequency not reported: Pulmonary exacerbation

Parenteral formulations:

• Uncommon (0.1% to 1%): Apnea, respiratory depression^[Ref]

Other

Inhalation Capsules:

• Very common (10% or more): Pyrexia (up to 15.6%)
• Common (1% to 10%): Deafness, deafness unilateral, hypoacusis, increased hearing loss, mild to moderate hearing loss, tinnitus
• Frequency not reported: Malaise

Inhalation/nebulizer solution:

• Very common (10% or more): Fever (up to 46%), asthenia (up to 44%), pain (up to 24%), pyrexia (up to 12.4%)
• Common (1% to 10%): Accidental injury, chills, malaise, otitis media, tinnitus
• Uncommon (0.1% to 1%): Deafness neurosensory, hypoacusis, mucosal dryness
• Rare (0.01% to 0.1%): Hearing loss
• Very rare (less than 0.01%): Ear disorder, ear pain
• Frequency not reported: Ototoxicity

Parenteral formulations:

• Common (1% to 10%): Hearing loss/irreversible hearing loss, high frequency hearing loss, ototoxicity, roaring in the ears, tinnitus
• Rare (0.01% to 0.1%): Fever
• Frequency not reported: Transient cochlear toxicity^[Ref]

Ototoxicity, usually irreversible, was typically initially manifested by diminution of high-tone acuity, dizziness, hearing loss, roaring in the ears, tinnitus, and vertigo. Patients receiving inhalation formulations with a history of prolonged treatment and/or receiving concomitant IV treatment with an aminoglycoside have developed hearing loss. Ototoxicity may progress despite discontinuation in some patients.

Tinnitus was typically transient, usually resolved without discontinuation of treatment, and was associated with permanent hearing loss in some patients.^[Ref]

Nervous system

Inhalation Capsules:

• Very common (10% or more): Headache (up to 11.4%)
• Common (1% to 10%): Aphonia, dysgeusia

Inhalation/nebulizer solution:

• Very common (10% or more): Headache (up to 34%), dysphonia (up to 13%)
• Common (1% to 10%): Dizziness, somnolence, taste perversion
• Uncommon (0.1% to 1%): Dysgeusia, vertigo
• Rare (0.01% to 0.1%): Aphonia

Parenteral formulations:

• Common (1% to 10%): Acute dizziness/dizziness, vertigo, vestibular dysfunction
• Uncommon (0.1% to 1%): Exacerbation of impairment of neuromuscular transmission, neuromuscular blocking effects
• Rare (0.01% to 0.1%): Acute brain syndrome, lethargy, neurotoxicity
• Frequency not reported: Headache^[Ref]

Acute brain syndrome occurred in an elderly patient approximately 4 days after starting treatment.^[Ref]

Cardiovascular

Inhalation Capsules:

• Common (1% to 10%): Chest discomfort

Inhalation/nebulizer solution:

• Very common (10% or more): Chest pain (up to 37%)
• Common (1% to 10%): Chest discomfort^[Ref]

Gastrointestinal

Inhalation Capsules:

• Common (1% to 10%): Diarrhea, nausea, vomiting

Inhalation/nebulizer solution:

• Very common (10% or more): Abdominal pain (up to 27%)
• Common (1% to 10%): Diarrhea, nausea, vomiting
• Uncommon (0.1% to 1%): Abdominal pain upper, glossitis, salivary hypersecretion
• Rare (0.01% to 0.1%): Mouth ulceration

Parenteral formulations:

• Common (1% to 10%): Diarrhea, nausea, vomiting
• Rare (0.01% to 0.1%): Stomatitis^[Ref]

Renal

Inhalation/nebulizer solution:

• Frequency not reported: Nephrotoxicity

Parenteral formulations:

• Common (1% to 10%): Decreased glomerular filtration, elevated urea concentrations, increased blood urea nitrogen (BUN), increased nonprotein nitrogen (NPN), oliguria, reduced creatinine clearance, reduced renal function, renal function changes, reversible nephrotoxicity
• Uncommon (0.1% to 1%): Increased serum creatinine
• Rare (0.01% to 0.1%): Acute renal failure, interstitial nephritis^[Ref]

Nephrotoxicity, demonstrated by rising BUN, NPN, serum creatinine, cylindruria, oliguria, and proteinuria, 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.

Signs of renal failure included elevated serum creatinine and urea, and may be a rare complication in patients with cystic fibrosis.^[Ref]

Musculoskeletal

Inhalation Capsules:

• Common (1% to 10%): Musculoskeletal chest pain

Inhalation/nebulizer solution:

• Common (1% to 10%): Back pain, musculoskeletal chest pain, myalgia

Parenteral formulations:

• Uncommon (0.1% to 1%): Skeletal muscle weakness^[Ref]

Dermatologic

Inhalation Capsules:

• Common (1% to 10%): Rash

Inhalation/nebulizer solution:

• Common (1% to 10%): Rash
• Very rare (less than 0.01%): Pruritus, urticaria

Parenteral formulations:

• Uncommon (0.1% to 1%): Itching, maculopapular rash, urticaria
• Rare (0.01% to 0.1%): Exfoliative dermatitis, rash^[Ref]

Genitourinary

Parenteral formulations:

• Common (1% to 10%): Cylindruria, increased proteinuria^[Ref]

Immunologic

Inhalation/nebulizer solution:

• Common (1% to 10%): Flu syndrome
• Uncommon (0.1% to 1%): Fungal infection, oral candidiasis^[Ref]

Metabolic

Inhalation Capsules:

• Common (1% to 10%): Blood glucose increased

Inhalation/nebulizer solution:

• Uncommon (0.1% to 1%): Blood glucose increased
• Rare (0.01% to 0.1%): Anorexia
• Postmarketing reports: Decreased appetite

Parenteral formulations:

• Rare (0.01% to 0.1%): Hypoalbuminemia, hypocalcemia, hypokalemia, hypomagnesemia, hypophosphatemia, hypouricemia, metabolic syndrome
• Frequency not reported: Increased serum lactate dehydrogenase^[Ref]

Patients have developed a complex metabolic syndrome lasting approximately 2 to 8 weeks after administration of this drug; this syndrome was marked by hypoalbuminemia, hypocalcemia, hypokalemia, hypomagnesemia, hypophosphatemia, hypouricemia, and increased AST, ALT, serum bilirubin, and alkaline phosphatase.^[Ref]

Hematologic

Inhalation/nebulizer solution:

• Common (1% to 10%): Lymphadenopathy

Parenteral formulations:

• Rare (0.01% to 0.1%): Anemia, chemotaxis inhibition, decreased platelet counts, decreased white cell counts, eosinophilia, granulocytopenia, inhibition of microbicidal activity of phagocytes, thrombocytopenia
• Frequency not reported: Leukocytosis, leukopenia^[Ref]

Hepatic

Inhalation/nebulizer solution:

• Uncommon (0.1% to 1%): Transaminases increased

Parenteral formulations:

• Rare (0.01% to 0.1%): Increased alkaline phosphatase, increased ALT, increased AST, increased serum bilirubin^[Ref]

Hypersensitivity

Inhalation/nebulizer solution:

• Very rare (less than 0.01%): Hypersensitivity

Parenteral formulations:

• Rare (0.01% to 0.1%): Anaphylaxis, angioedema, hypersensitivity reactions^[Ref]

Hypersensitivity reactions included anaphylaxis, angioedema, exfoliative dermatitis, and stomatitis.^[Ref]

Local

Parenteral formulations:

• Rare (0.01% to 0.1%): Pain (IM administration), thrombophlebitis (IV administration)^[Ref]

Psychiatric

Parenteral formulations:

• Frequency not reported: Delirium, disorientation, mental confusion^[Ref]

Delirium was reversible after treatment was discontinued.^[Ref]

See also:

Further information

Tobramycin side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer