Two medicines, side by side
Amikacin vs tobramycin
Amikacin and tobramycin are both labeled for bacterial infections. Drugs@FDA records approvals of amikacin since 2018 and of tobramycin since 1975. Pharmacies paid $2.33 per mL (Amikacin sulf 500 mg/2 mL vial) and $1.08 per mL (Tobramycin 300 mg/5 mL ampule) (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. Only the amikacin label carries a boxed warning.
Check it at the source: the amikacin FDA label on DailyMed (effective December 10, 2025); the tobramycin FDA label on DailyMed (effective November 1, 2023).
Highlights of the amikacin record
Amikacin (Arikayce) · label of December 10, 2025
Patients treated with parenteral aminoglycosides should be under close clinical observation because of the potential ototoxicity and nephrotoxicity associated with their use. Safety for treatment periods which are longer than 14 days has not been established.
Used for
From the label: indicationsAmikacin Sulfate Injection is indicated in the short-term treatment of serious infections due to susceptible strains of Gram-negative bacteria, including Pseudomonas species, Escherichia coli, species of indole-positive and indole-negative Proteus, Providencia species, Klebsiella-Enterobacter-Serratia species, and Acinetobacter ( Mima-Herellea ) species. […]
On the market
- Earliest approval on file
- September 28, 2018
- Generic labelers
- 6 labelers
- Pharmacy cost
- $2.33 per mL
Supply and safety
- Shortage
- No current entry
- Recalls
- 4
Highlights of the tobramycin record
Tobramycin (Tobi) · label of November 1, 2023
Used for
From the label: indicationsTobramycin ophthalmic solution, 0.3% is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. Appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of tobramycin ophthalmic solution. Clinical studies have shown tobramycin to be safe and effective for use in children.
On the market
- Earliest approval on file
- June 11, 1975
- Generic labelers
- 40 labelers
- Pharmacy cost
- $1.08 per mL
Supply and safety
- Shortage
- A presentation being discontinued
- Recalls
- 8
Source: FDA drug labels via openFDA (Amikacin label of December 10, 2025, Tobramycin label of November 1, 2023); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do amikacin and tobramycin differ on the record?
Only the amikacin label carries a boxed warning.
Both are in FDA's class aminoglycoside antibacterials.
Generics: amikacin since 1981; tobramycin since 1976 (Drugs@FDA).
| Amikacin | Tobramycin | |
|---|---|---|
| Labeled for | Bacterial infections | Bacterial infections, Urinary tract infections |
| Pharmacologic class | Aminoglycoside Antibacterial | Aminoglycoside Antibacterial |
| How it works (label) | n/a | n/a |
| Half-life (label) | General Pharmacokinetic studies in normal adult subjects reveal the mean serum half-life to be slightly over 2 hours with a mean total apparent volume of distribution of 24 liters (28% of the body weight). | n/a |
| Earliest approval on file (Drugs@FDA) | September 28, 2018 | June 11, 1975 |
| First generic approved | January 22, 1981 | October 1, 1976 |
| Generic labelers (NDC) | 6 labelers | 40 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $2.33 per mL (Amikacin sulf 500 mg/2 mL vial) | $1.08 per mL (Tobramycin 300 mg/5 mL ampule) |
| 12-month price change | -23% | -26% |
| Boxed warning | Yes | No |
| Shortage now | No current entry | A presentation being discontinued |
| Recalls recorded | 4 | 8 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 18,617 | 24,368 |
| DEA schedule | none | none |
Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)
What next?
- Alternatives to amikacin
- every medicine labeled for the same conditions