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Two medicines, side by side

Cefuroxime vs cephalexin

Cefuroxime and cephalexin are both labeled for bacterial infections and urinary tract infections. Drugs@FDA records approvals of cefuroxime since 1983 and of cephalexin since 1971. Pharmacies paid $0.280 per cefuroxime axetil 250 mg tablet and $0.120 per cephalexin 500 mg capsule (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. How each works, in its label's words: Cefuroxime, “Cefuroxime axetil is an antibacterial drug [see Microbiology (12.4) ].”; Cephalexin, “Cephalexin is a cephalosporin antibacterial drug [see Microbiology ( 12.4 )].”

Check it at the source: the cefuroxime FDA label on DailyMed (effective April 29, 2024); the cephalexin FDA label on DailyMed (effective December 31, 2020).

Highlights of the cefuroxime record

Cefuroxime (Zinacef) · label of April 29, 2024

Used for

From the label: indications

Cefuroxime axetil tablets are a cephalosporin antibacterial drug indicated for the treatment of the following infections due to susceptible bacteria: ( 1 ) Pharyngitis/tonsillitis (adults and pediatric patients) ( 1.1 ) Acute bacterial otitis media (pediatric patients) ( 1.2 ) Acute bacterial maxillary sinusitis (adults and pediatric patients) ( 1.3 ) Acute bacterial exacerbations of chronic bronchitis (adults and […]

On the market

Earliest approval on file
October 19, 1983
Generic labelers
19 labelers
Pharmacy cost
$0.280 per tablet

Supply and safety

Shortage
No current entry
Recalls
1

Highlights of the cephalexin record

Cephalexin (Keflex) · label of December 31, 2020

Used for

From the label: indications

Cephalexin is a cephalosporin antibacterial drug indicated for the treatment of the following infections caused by susceptible isolates of designated bacteria: Respiratory tract infection ( 1.1 ) Otitis media ( 1.2 ) Skin and skin structure infections ( 1.3 ) Bone infections ( 1.4 ) Genitourinary tract infections ( 1.5 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of […]

On the market

Earliest approval on file
January 4, 1971
Generic labelers
35 labelers
Pharmacy cost
$0.120 per capsule

Supply and safety

Shortage
No current entry
Recalls
22

Source: FDA drug labels via openFDA (Cefuroxime label of April 29, 2024, Cephalexin label of December 31, 2020); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)

How do cefuroxime and cephalexin differ on the record?

How each works, in its label's words: Cefuroxime, “Cefuroxime axetil is an antibacterial drug [see Microbiology (12.4) ].”; Cephalexin, “Cephalexin is a cephalosporin antibacterial drug [see Microbiology ( 12.4 )].”

Both are in FDA's class cephalosporin antibacterials.

Generics: cefuroxime since 1986; cephalexin since 1976 (Drugs@FDA).

CefuroximeCephalexin
Labeled forBacterial infections, Urinary tract infectionsBacterial infections, Urinary tract infections
Pharmacologic classCephalosporin AntibacterialCephalosporin Antibacterial
How it works (label)Cefuroxime axetil is an antibacterial drug [see Microbiology (12.4) ].Cephalexin is a cephalosporin antibacterial drug [see Microbiology ( 12.4 )].
Half-life (label)n/an/a
Earliest approval on file (Drugs@FDA)October 19, 1983January 4, 1971
First generic approvedJanuary 10, 1986April 26, 1976
Generic labelers (NDC)19 labelers35 labelers
Pharmacy cost (NADAC, each one's most listed form; strengths differ)$0.280 per tablet (Cefuroxime axetil 250 mg tablet)$0.120 per capsule (Cephalexin 500 mg capsule)
12-month price change-3%-6%
Boxed warningNoNo
Shortage nowNo current entryNo current entry
Recalls recorded122
FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used)15,67021,515
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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