Tobi Side Effects
Generic name: tobramycin
Medically reviewed by Drugs.com. Last updated on Apr 26, 2025.
Note: This document provides detailed information about Tobi Side Effects associated with tobramycin. Some dosage forms listed on this page may not apply specifically to the brand name Tobi.
Applies to tobramycin: injection solution.
Other dosage forms:
Important warnings
This medicine can cause some serious health issues
Injection route (solution; powder for solution)
Therapy has been associated with potential neurotoxicity, ototoxicity, and nephrotoxicity.
Patients with impaired renal function, advanced age, dehydration, and those who receive high dosage or prolonged therapy are at an increased risk of toxicity.
Monitor renal and auditory function during therapy and discontinue therapy or adjust dose if there is evidence of ototoxicity or nephrotoxicity.
Aminoglycoside-induced ototoxicity is usually irreversible.
Serum concentrations of aminoglycosides should be monitored periodically to assure adequate levels and to avoid potentially toxic levels.
Concurrent use of other potentially neurotoxic or nephrotoxic agents, or potent diuretics should be avoided.
Tobramycin should be used with caution in premature and neonatal infants because of their renal immaturity and the resulting prolongation of serum half-life of the drug.
Aminoglycosides can cause fetal harm when administered to a pregnant woman.
Precautions
Your doctor will check your progress closely while you or your child are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you or your child should continue to receive it. Blood, urine, hearing, and nerve tests may be needed to check for unwanted effects. Electrolytes (e.g., calcium, magnesium, and potassium) in the blood should also be monitored by your doctor.
If your or your child's symptoms do not improve within a few days, or if they become worse, check with your doctor.
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.
This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you or your child have blistering, peeling, or loosening of the skin; itching; hives; hoarseness; shortness of breath; sores, ulcers, or white spots in the mouth or on the lips; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth after you receive this medicine.
Stop using this medicine and check with your doctor right away if you or your child have sudden decrease in hearing or loss of hearing, which may be accompanied by dizziness and ringing in the ears. Tell your doctor if you or your child have dizziness or lightheadedness; feeling of constant movement of self or surroundings; or sensation of spinning. These may be symptoms of damage to your hearing or sense of balance.
Check with your doctor right away if you or your child have blood in the urine, change in frequency of urination or amount of urine, difficulty with breathing, drowsiness, increased thirst, loss of appetite, nausea or vomiting, swelling of feet or lower legs, or weakness. These may be symptoms of a serious kidney problem.
This medicine may cause nerve problems. Check with your doctor right away if you or your child have numbness, skin tingling, muscle twitching, or seizures.
Make sure your doctor knows that you or your child are using this medicine before having a surgery or other procedures that require you to receive a numbing medicine (e.g., anesthetics, neuromuscular blocking agents). Using tobramycin (the active ingredient contained in Tobi) injection together with numbing medicines may increase your risk of having difficulty in breathing, drowsiness, inability to breathe without assistance, or unusual tiredness or weakness.
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 Tobi
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 or nurse immediately if any of the following side effects occur while taking tobramycin:
Incidence not known
- black, tarry stools
- bleeding gums
- blood in the urine or stools
- chills
- cloudy urine
- clumsiness
- continuing ringing or buzzing or other unexplained noise in the ears
- cough
- cracks in the skin
- decrease in the amount of urine
- dizziness or lightheadedness
- feeling of constant movement of self or surroundings
- feeling of fullness in the ears
- fever
- loss of balance
- loss of heat from the body
- loss or change in hearing
- nausea
- pale skin
- pinpoint red spots on the skin
- red, swollen skin
- scaly skin
- sensation of spinning
- shortness of breath
- sore throat
- trouble in hearing
- troubled breathing with exertion
- ulcers, sores, or white spots in the mouth
- unsteadiness
- unusual bleeding or bruising
- unusual tiredness or weakness
- vomiting
Get emergency help immediately if any of the following symptoms of overdose occur while taking tobramycin:
Symptoms of overdose
- inability to breath without assistance
Other side effects of Tobi
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:
Incidence not known
- confusion about identity, place, and time
- diarrhea
- headache
- hives or welts
- itching
- pain at the injection site
- redness of the skin
- skin rash
- unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
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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]
References
1. (2001) "Product Information. Nebcin (tobramycin)." Lilly, Eli and Company
2. (2022) "Product Information. Tobi (tobramycin)." PathoGenesis
3. Cerner Multum, Inc. "UK Summary of Product Characteristics."
4. Cerner Multum, Inc. "Australian Product Information."
More about Tobi (tobramycin)
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Further information
Tobi 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.