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Two medicines, side by side

Amoxicillin vs cephalexin

Amoxicillin and cephalexin are both labeled for bacterial infections. Drugs@FDA records approvals of amoxicillin since 1974 and of cephalexin since 1971. Pharmacies paid $0.0788 per amoxicillin 500 mg capsule and $0.120 per cephalexin 500 mg capsule (NADAC, October 7, 2026). In FDA's classes, amoxicillin is a penicillin-class antibacterial and cephalexin a cephalosporin antibacterial.

Check it at the source: the amoxicillin FDA label on DailyMed (effective February 22, 2024); the cephalexin FDA label on DailyMed (effective December 31, 2020).

Highlights of the amoxicillin record

Amoxicillin (Amoxil) · label of February 22, 2024

Used for

From the label: indications

Adults and Pediatric Patients • Upper Respiratory Tract Infections of the Ear, Nose, and Throat Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus species. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp. , or Haemophilus influenzae. […]

On the market

Earliest approval on file
January 18, 1974
Generic labelers
38 labelers
Pharmacy cost
$0.0788 per capsule

Supply and safety

Shortage
No current entry
Recalls
12

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 (Amoxicillin label of February 22, 2024, Cephalexin label of December 31, 2020); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)

How do amoxicillin and cephalexin differ on the record?

In FDA's classes, amoxicillin is a penicillin-class antibacterial and cephalexin a cephalosporin antibacterial.

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

Generics: amoxicillin since 1974; cephalexin since 1976 (Drugs@FDA).

AmoxicillinCephalexin
Labeled forBacterial infections, Acid reflux and ulcersBacterial infections, Urinary tract infections
Pharmacologic classPenicillin-class AntibacterialCephalosporin Antibacterial
How it works (label)Amoxicillin is an antibacterial drug [see Microbiology ( 12.4 )].Cephalexin is a cephalosporin antibacterial drug [see Microbiology ( 12.4 )].
Half-life (label)Metabolism and Excretion The half-life of amoxicillin is 61.3 minutes.n/a
Earliest approval on file (Drugs@FDA)January 18, 1974January 4, 1971
First generic approvedDecember 9, 1974April 26, 1976
Generic labelers (NDC)38 labelers35 labelers
Pharmacy cost (NADAC, each one's most listed form; strengths differ)$0.0788 per capsule (Amoxicillin 500 mg capsule)$0.120 per capsule (Cephalexin 500 mg capsule)
12-month price change-12%-6%
Boxed warningNoNo
Shortage nowNo current entryNo current entry
Recalls recorded1222
FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used)75,92621,515
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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