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Two medicines, side by side

Amikacin vs levofloxacin

Amikacin and levofloxacin are both labeled for bacterial infections. Drugs@FDA records approvals of amikacin since 2018 and of levofloxacin since 1996. Pharmacies paid $2.33 per mL (Amikacin sulf 500 mg/2 mL vial) and $0.259 per levofloxacin 750 mg tablet (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. In FDA's classes, amikacin is an aminoglycoside antibacterial and levofloxacin a fluoroquinolone antibacterial.

Check it at the source: the amikacin FDA label on DailyMed (effective December 10, 2025); the levofloxacin FDA label on DailyMed (effective July 10, 2024).

Highlights of the amikacin record

Amikacin (Arikayce) · label of December 10, 2025

Boxed warning

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: indications

Amikacin 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 levofloxacin record

Levofloxacin (Levaquin) · label of July 10, 2024

Boxed warning

SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS See full prescribing information for complete boxed warning.

Used for

From the label: indications

Levofloxacin is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with infections caused by designated, susceptible bacteria and in pediatric patients where indicated ( 1 , 12.4 ). […]

On the market

Earliest approval on file
December 20, 1996
Generic labelers
44 labelers
Pharmacy cost
$0.259 per tablet

Supply and safety

Shortage
No current entry
Recalls
13

Source: FDA drug labels via openFDA (Amikacin label of December 10, 2025, Levofloxacin label of July 10, 2024); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)

How do amikacin and levofloxacin differ on the record?

In FDA's classes, amikacin is an aminoglycoside antibacterial and levofloxacin a fluoroquinolone antibacterial.

Half-life, in each label's words: Amikacin, “General Pharmacokinetic studies in normal adult subjects reveal the mean serum half-life to be slightly over 2 hours …”; Levofloxacin, “The mean terminal plasma elimination half-life of levofloxacin ranges from approximately 6 to 8 hours following single …”

Both labels carry a boxed warning; the records quote them.

Generics: amikacin since 1981; levofloxacin since 2010 (Drugs@FDA).

AmikacinLevofloxacin
Labeled forBacterial infectionsBacterial infections, Urinary tract infections
Pharmacologic classAminoglycoside AntibacterialFluoroquinolone Antibacterial
How it works (label)n/aLevofloxacin is a member of the fluoroquinolone class of antibacterial agents [see Microbiology ( 12.4 )].
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).The mean terminal plasma elimination half-life of levofloxacin ranges from approximately 6 to 8 hours following single or multiple doses of levofloxacin given orally or intravenously.
Earliest approval on file (Drugs@FDA)September 28, 2018December 20, 1996
First generic approvedJanuary 22, 1981December 20, 2010
Generic labelers (NDC)6 labelers44 labelers
Pharmacy cost (NADAC, each one's most listed form; strengths differ)$2.33 per mL (Amikacin sulf 500 mg/2 mL vial)$0.259 per tablet (Levofloxacin 750 mg tablet)
12-month price change-23%-11%
Boxed warningYesYes
Shortage nowNo current entryNo current entry
Recalls recorded413
FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used)18,61759,954
DEA schedulenonenone

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?

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