Tobramycin: uses, dosing, side effects & brands
Tobramycin is an aminoglycoside antibacterial sold in the U.S. under 6 brand and generic names, for infectious bone diseases, central nervous system infections and pseudomonas infections. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Aminoglycoside Antibacterial
- Treats (across its forms)
- Infectious Bone Diseases, Central Nervous System Infections and Pseudomonas Infections
- Available as
- Solution · Capsule · Topical · Injectable · Drops
- Sold as
- 6 products — Bethkis, Tobi and Tobi Podhaler, and others
- Prescription?
- Prescription only
- Generic available?
- Yes
- What the pharmacy pays
- about $1 per ml — not your price
How Bethkis is dosed
From the FDA label for Bethkis (application NDA201820). Other tobramycin products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
For oral inhalation only ( 2.1 ) Administer the entire contents of one ampule twice daily by oral inhalation in repeated cycles of 28 days on drug, followed by 28 days off drug. ( 2.1 ) 2.1 Dosage Bethkis is for oral inhalation only [see Dosage and Administration ( 2.2 )] . The recommended dosage of BETHKIS for patients six years of age and older is to administer one single-use ampule (300 mg/4 mL) twice daily by oral inhalation in repeated cycles of 28 days on drug, followed by 28 days off drug. The doses should be taken as close to 12 hours apart as possible and not less than 6 hours apart. The 300 mg/4 mL dose of BETHKIS is the same for patients regardless of age or weight. BETHKIS has not been studied in patients less than six years old. If patients miss a dose, they should take it as soon as possible anytime up to 6 hours prior to their next scheduled dose. If less than 6 hours remain before the next dose, wait until their next scheduled dose. 2.2 Administration Instructions BETHKIS is administered by oral inhalation using a hand-held PARI LC PLUS Reusable Nebulizer with a PARI Vios Air compressor over an approximately 15 minute period and until sputtering from the output of the nebulizer has occurred for at least one minute. BETHKIS should not be diluted or mixed with dornase alfa or other medications in the nebulizer. BETHKIS is not for subcutaneous, intravenous, or…
Everything below is the FDA label for Bethkis (solution). Tobramycin is also sold as capsule, topical, injectable and drops, and those are different medicines to take — follow the label for the one you were prescribed.
Bethkis side effects
Common adverse reactions (more than 5%) occurring more frequently in BETHKIS patients are forced expiratory volume decreased, rales, red blood cell sedimentation rate increased, and dysphonia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Chiesi USA, Inc. at 1-888-661-9260 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of drugs cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below reflect exposure to BETHKIS in two placebo-controlled studies in 305 cystic fibrosis patients. Patients receiving BETHKIS ranged in age from 6 to 31 years. In Study 1, an eight week study, 29 patients received BETHKIS versus 30 patients who received placebo for a total of four weeks on drug and four weeks off drug. All patients were ≤ 30 years of age (mean age 12.6 years) and 46% were females. 52.5% of patients were 6 to 12 years of age while 30.5% of patients were 13-17 years old. Only 16.5% of patients were adults (> 17 years old). Eighty percent (80%) of patients were chronically colonized with Pseudomonas aeruginosa while 20.3% of patients were initially or intermittently colonized with Pseudomonas aeruginosa during the study. More…
Who shouldn’t take Bethkis
BETHKIS is contraindicated in patients with a known hypersensitivity to any aminoglycoside. BETHKIS is contraindicated in patients with a known hypersensitivity to any aminoglycoside. ( 4 )
Bethkis drug interactions
Concurrent and/or sequential use of BETHKIS with other drugs with neurotoxic, nephrotoxic or ototoxic potential should be avoided. ( 7.1 ) BETHKIS should not be administered concomitantly with ethacrynic acid, furosemide, urea, or intravenous mannitol. ( 7.2 ) 7.1 Drugs with Neurotoxic, Nephrotoxic, or Ototoxic Potential Concurrent and/or sequential use of BETHKIS with other drugs with neurotoxic, nephrotoxic, or ototoxic potential should be avoided. 7.2 Diuretics Some diuretics can enhance aminoglycoside toxicity by altering antibiotic concentrations in serum and tissue. Therefore, BETHKIS should not be administered concomitantly with ethacrynic acid, furosemide, urea, or intravenous mannitol. The interaction between inhaled mannitol and BETHKIS has not been evaluated.
Every tobramycin product we track (6)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | 70/100 | Prescription | Solution | Generic | $1 | View → | |
| 2 | 70/100 | Prescription | Solution | Generic | $1 | View → | |
| 3 | 70/100 | Prescription | Capsule | Generic | $1 | View → | |
| 4 | 68/100 | Prescription | Topical | Generic | $1 | View → | |
| 5 | Not yet rated | Prescription | Solution | Generic | $1 | View → | |
| 6 | Not yet rated | Prescription | Injectable | Generic | $1 | View → |
What tobramycin pills look like
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| MYL;TPH | 28 mg | white | capsule | — |
Combination products containing tobramycin
A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.
Tobramycin recalls
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
How long tobramycin keeps
The date on a sealed pack is not the only one: some tobramycin labels start a second clock once the product is opened or mixed, as short as 24 hours.
Does tobramycin expire? The in-use limits and storage rules from its labelsTobramycin and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for tobramycin: levels in milk, effects in breastfed infants, and the drugs it would consider insteadTobramycin is poorly excreted into breastmilk. Newborn infants apparently absorb small amounts of other aminoglycosides, but serum levels with three times daily dosages are far below those attained when treating newborn infections and systemic effects of tobramycin are unlikely. Older infants would be expected to absorb even less tobramycin. Because there is little variability in the milk tobramycin levels during multiple daily dose regimens, timing breastfeeding with respect to the dose is of little or no benefit in reducing infant exposure. Data are not available with single daily dose regimens. Monitor the infant for possible effects on the gastrointestinal flora, such as diarrhea, candidiasis (e.g., thrush, diaper rash) or rarely, blood in the stool indicating possible antibiotic-associated colitis.
National Institute of Child Health and Human Development, record revised October 15, 2024. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about tobramycin
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 15,292 reports naming tobramycin, and the FDA flagged 77% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- pneumonia926 reports
- dyspnoea784 reports
- acute kidney injury739 reports
- infective pulmonary exacerbation of cystic fibrosis644 reports
- hospitalisation628 reports
- cough507 reports
- infection500 reports
- cystic fibrosis497 reports
Read these as a signal, not a rate. A report does not mean tobramycin caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 26, 2026.
Related calculators
Frequently asked questions
What is Bethkis?
BETHKIS is a sterile, clear, colorless to pale yellow, non-pyrogenic, aqueous solution with pH and salinity adjusted. BETHKIS is administered by a compressed air driven reusable nebulizer.
What kind of drug is tobramycin?
The FDA classifies tobramycin as an aminoglycoside antibacterial. Aminoglycosides kill bacteria by latching onto the germ's protein-making machinery (the 30S ribosomal subunit). This jams and misreads the bacterial genetic code so the microbe builds faulty proteins it can't survive on, which is why these drugs destroy the bacteria rather than just stopping their growth. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take tobramycin with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run tobramycin against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is tobramycin sold under?
We track 6 tobramycin-containing products in the U.S.: Bethkis, Tobi, Tobi Podhaler, Tobrex, Kitabis Pak and Tobramycin. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does tobramycin come in?
Across the brands we track, tobramycin is currently marketed as solution, capsule, topical, injectable and drops, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic tobramycin?
Yes. Our catalog lists 2 generic tobramycin products alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.
Has tobramycin been recalled?
The FDA's Enforcement database lists 1 recall record whose product description mentions tobramycin. The most recent: Tobramycin for Injection (Feb 22, 2024). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.
Cite this page
- APA
- pharmaranks. (2026, July 24). Tobramycin: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/tobramycin
- MLA
- “Tobramycin: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/tobramycin.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for tobramycin on DailyMed (NIH) ↗.