Two medicines, side by side
Amikacin vs gentamicin
Amikacin and gentamicin are both labeled for bacterial infections. Drugs@FDA records approvals of amikacin since 2018 and of gentamicin since 1970. Pharmacies paid $2.33 per mL (Amikacin sulf 500 mg/2 mL vial) and $1.30 per mL (Gentamicin 80 mg/2 mL vial) (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 gentamicin FDA label on DailyMed (effective July 22, 2024).
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 gentamicin record
Gentamicin (Garamycin) · label of July 22, 2024
Used for
From the label: indicationsGentamicin sulfate ophthalmic solution is indicated in the topical treatment of ocular bacterial infections including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivitis, acute meibomianitis, and dacryocystitis, caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens. […]
On the market
- Earliest approval on file
- June 19, 1970
- Generic labelers
- 24 labelers
- Pharmacy cost
- $1.30 per mL
Supply and safety
- Shortage
- No current entry
- Recalls
- 9
Source: FDA drug labels via openFDA (Amikacin label of December 10, 2025, Gentamicin label of July 22, 2024); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do amikacin and gentamicin differ on the record?
Only the amikacin label carries a boxed warning.
Both are in FDA's class aminoglycoside antibacterials.
Generics: amikacin since 1981; gentamicin since 1966 (Drugs@FDA).
| Amikacin | Gentamicin | |
|---|---|---|
| Labeled for | Bacterial infections | Bacterial 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 19, 1970 |
| First generic approved | January 22, 1981 | March 15, 1966 |
| Generic labelers (NDC) | 6 labelers | 24 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $2.33 per mL (Amikacin sulf 500 mg/2 mL vial) | $1.30 per mL (Gentamicin 80 mg/2 mL vial) |
| 12-month price change | -23% | -21% |
| Boxed warning | Yes | No |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 4 | 9 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 18,617 | 15,709 |
| 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