What the label lists and what reports show
Tobramycin side effects
Tobramycin's FDA label lists its adverse reactions in its own words. FAERS holds 24,368 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is infective pulmonary exacerbation of cystic fibrosis (1,590 reports).
- Generic listed
- A presentation discontinued
Check it at the source: the tobramycin FDA label on DailyMed (effective November 1, 2023, Bausch & Lomb Incorporated); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of TOBI?TOBI may cause serious side effects, including: • severe breathing problems (bronchospasm). Tell your healthcare provider right away if you get any of these symptoms of bronchospasm with using TOBI: o shortness of breath with wheezing o coughing and chest tightness • hearing loss or ringing in the ears (ototoxicity). Tell your healthcare provider right away if you have hearing loss or you hear noises in your ears such as ringing or hissing. Tell your healthcare provider if you develop vertigo, difficulty with balance or dizziness. • worsening kidney problems (nephrotoxicity). TOBI is in a class of drugs which may cause worsening kidney problems, especially in people with known or suspected kidney problems. Your healthcare provider may do a blood test to check how your kidneys are working while you are using TOBI. • worsening muscle weakness (neuromuscular disorder). […]
Source: FDA drug label (TOBI), Viatris Specialty LLC, effective November 15, 2025 (SPL set 6a3c3871-1d3a-44d6-8be3-526b30123ef7), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most frequent adverse reactions to tobramycin ophthalmic solution, 0.3% are hypersensitivity and localized ocular toxicity, including lid itching and swelling, and conjunctival erythema. These reactions occur in less than three of 100 patients treated with tobramycin ophthalmic solution. Postmarketing Experience Additional adverse reactions identified from postmarketing use include anaphylactic reaction, Stevens-Johnson syndrome, and erythema multiforme. The following additional adverse reactions have been reported with systemic aminoglycosides: Neurotoxicity, ototoxicity and nephrotoxicity have occurred in patients receiving systemic aminoglycoside therapy. Aminoglycosides may aggravate muscle weakness in patients with known or suspected neuromuscular disorders, such as myasthenia gravis or Parkinson’s disease, because of their potential effect on neuromuscular function. …
Table 1: Percent of Patients with Selected Adverse Reactions Occurring in > 5% of TOBI Patients
This table is printed in the TOBI label published by Viatris Specialty LLC of November 15, 2025; the label quoted above does not print one.
| Adverse Reaction | Tobramycin Inhalation Solution (n = 258) % | Placebo (n = 262) % |
|---|---|---|
| Cough Increased | 46.1 | 47.3 |
| Pharyngitis | 38.0 | 39.3 |
| Sputum Increased | 37.6 | 39.7 |
| Dyspnea | 33.7 | 38.5 |
| Hemoptysis | 19.4 | 23.7 |
| Lung Function Decreased Includes reported decreases in pulmonary function tests or… | 16.3 | 15.3 |
| Voice Alteration | 12.8 | 6.5 |
| Taste Perversion | 6.6 | 6.9 |
| Rash | 5.4 | 6.1 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
Source: FDA drug label, Bausch & Lomb Incorporated, effective November 1, 2023 (SPL set a5693ec9-d2f7-4d45-90b0-a113c54840d7), via openFDA; the full label on DailyMed
What do FAERS reports show?
24,368 reports list tobramycin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 2,885 are coded as a death and 11,583 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 17 reactions below, 4 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Tobramycin: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions