Tobramycin
Active ingredient · 2 therapeutic classes
Sold as TOBI · Vantobra · TOBREX · TOBRADEX · TOBI PODHALER
- Drug class
- Other Aminoglycosides
- Availability
- Prescription only
- Routes
- Inhalation, Intramuscular, Ophthalmic, Intravenous, Respiratory (Inhalation)
- Markets covered
- 4
- Products on record
- 54
- FDA reports (12 mo)
- 1,131
Overview
Plain-language summary, compiled from the cited regulatory records
Tobramycin is an antibiotic belonging to the drug class of other aminoglycosides [1]. It is approved for treating serious bacterial infections caused by susceptible microorganisms [1]. These infections include septicemia in neonates, children, and adults, particularly when caused by *P. aeruginosa*, *E. coli*, and *Klebsiella* species [1]. Tobramycin is also indicated for lower respiratory tract infections caused by various bacteria, including *P. aeruginosa*, *Klebsiella* species, *Enterobacter* species, *Serratia* species, *E. coli*, and *S. aureus* [1].
In the past 12 months, there have been 1131 adverse event reports associated with tobramycin [2]. The most frequently reported adverse events include off-label use, pneumonia, drug ineffectiveness, hospitalization, and eye pain [2].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 26 | May 22, 2026 |
| CA Canada | Health Canada | 16 | May 19, 2026 |
| US United States | FDA | 10 | May 28, 2026 |
| EU European Union | EMA | 2 | May 11, 2026 |
GBUnited Kingdom· MHRA
26 products
Uses
Long-term management of chronic pulmonary infection due to Pseudomonas aeruginosa in cystic fibrosis (CF) patients aged 6 years and older. Consideration should be given to official guidance on the appropriate use of antibacterial agents.
How to take
CACanada· Health Canada
16 products
Uses
TOBI PODHALER (Tobramycin Inhalation Powder) is indicated for: • the management of cystic fibrosis (CF) patients aged 6 years or older with chronic pulmonary Pseudomonas aeruginosa (P. aeruginosa) infections. Safety and efficacy have not been demonstrated in patients with FEV1 (Forced Expiratory Volume in 1 second) < 25% or > 80% predicted, or patients colonized with Burkholderia cepacia.
Safety and efficacy of TOBI PODHALER has been demonstrated in clinical trials over 3 cycles (6 months) of therapy. To reduce the development of drug-resistant bacteria and maintain the effectiveness of TOBI PODHALER and other antibacterial drugs, TOBI PODHALER should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.
Culture and susceptibility testing performed periodically will provide information on changing microbial flora and the possible emergence of bacterial resistance (see 15 MICROBIOLOGY). 1 Pediatrics Pediatrics (≥ 6 years to < 18 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of TOBI PODHALER in pediatric patients 6 years of age and older has been established.
USUnited States· FDA
10 products
Uses
INDICATIONS AND USAGE:
Tobramycin and dexamethasone ophthalmic suspension is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.
Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation.
They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns, or penetration of foreign bodies. The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.
EUEuropean Union· EMA
2 products
Uses
TOBI
Podhaler is indicated for the suppressive therapy of chronic pulmonary infection due to Pseudomonas aeruginosa in adults and children aged 6 years and older with cystic fibrosis. 1 regarding data in different age groups. Consideration should be given to official guidance on the appropriate use of antibacterial agents.
How to take
Drug interactions
Known interactions involving Tobramycin. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 295. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PL177801221 · revised May 22, 2026
- [2]Health Canada (DPD) · 02365154 · revised March 22, 2025
- [3]FDA DailyMed · 1884ef6f-a60c-4a… · revised May 28, 2026 [PDF]
- [4]European Medicines Agency · EMEA/H/C/002155 · revised May 11, 2026
- [5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.