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Two medicines, side by side

Amikacin vs plazomicin

Amikacin is labeled for bacterial infections; plazomicin for urinary tract infections. Their labels share no use, so they are not alternatives to each other. Drugs@FDA records approvals of amikacin since 2018 and of plazomicin since 2018.

Check it at the source: the amikacin FDA label on DailyMed (effective December 10, 2025); the plazomicin FDA label on DailyMed (effective December 20, 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 plazomicin record

Plazomicin (Zemdri) · label of December 20, 2024

Boxed warning

NEPHROTOXICITY, OTOTOXICITY, NEUROMUSCULAR BLOCKADE and FETAL HARM Nephrotoxicity has been reported with ZEMDRI. The risk of nephrotoxicity is greater in patients with impaired renal function, the elderly, and in those receiving concomitant nephrotoxic medications. Assess creatinine clearance in all patients prior to initiating therapy and daily during therapy [see Dosage and Administration (2.2) and Warnings and Precautions (5.1) ].

Used for

From the label: indications

INDICATIONS AND USAGE ZEMDRI is an aminoglycoside antibacterial indicated for the treatment of patients 18 years of age or older with Complicated Urinary Tract Infections (cUTI) including Pyelonephritis. ( 1.1 ) As only limited clinical safety and efficacy data are available, reserve ZEMDRI for use in patients who have limited or no alternative treatment options. […]

On the market

Earliest approval on file
June 25, 2018
Generic labelers
none listed
Pharmacy cost
Not in the survey

Supply and safety

Shortage
No current entry
Recalls
0

Source: FDA drug labels via openFDA (Amikacin label of December 10, 2025, Plazomicin label of December 20, 2024); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)

How do amikacin and plazomicin differ on the record?

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

Generics: amikacin since 1981; plazomicin none approved (Drugs@FDA).

AmikacinPlazomicin
Labeled forBacterial infectionsUrinary tract infections
Pharmacologic classAminoglycoside Antibacterialn/a
How it works (label)n/aZEMDRI is an antibacterial drug [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).n/a
Earliest approval on file (Drugs@FDA)September 28, 2018June 25, 2018
First generic approvedJanuary 22, 1981none
Generic labelers (NDC)6 labelersnone listed
Pharmacy cost (NADAC, each one's most listed form; strengths differ)$2.33 per mL (Amikacin sulf 500 mg/2 mL vial)n/a
12-month price change-23%n/a
Boxed warningYesYes
Shortage nowNo current entryNo current entry
Recalls recorded40
FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used)18,6173
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?

Alternatives to amikacin
every medicine labeled for the same conditions