Last reviewed 2026-05-31 · How we verify

Azithromycin and amoxicillin

Azithromycin and amoxicillin is a Macrolide and beta-lactam antibiotic combination Small molecule drug developed by University of Alabama at Birmingham. It is currently FDA-approved for Bacterial infections susceptible to both azithromycin and amoxicillin. Also known as: azithromycin, amoxicillin.

This is a combination of two antibiotics that work by inhibiting bacterial protein synthesis (azithromycin via 50S ribosomal subunit) and inhibiting bacterial cell wall synthesis (amoxicillin via beta-lactam mechanism).

Azithromycin and amoxicillin are antibiotics used to treat various bacterial infections, including community-acquired bacterial pneumonia. They are also studied as potential treatments for other conditions such as skin cancer and non-alcoholic fatty liver disease, although the evidence for these uses is limited.

At a glance

Mechanism of action

Azithromycin is a macrolide antibiotic that binds to the bacterial 50S ribosomal subunit and inhibits protein synthesis. Amoxicillin is a beta-lactam antibiotic that inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins. Together, they provide broad-spectrum coverage against both gram-positive and gram-negative bacteria through complementary mechanisms.

Approved indications

• Bacterial infections susceptible to both azithromycin and amoxicillin

Common side effects

• Diarrhea
• Nausea
• Abdominal pain
• Rash
• Vomiting
• Headache

Key clinical trials

• Testing a Novel Combination Treatment (Arm D) Versus Standard of Care for Intensive Phase Treatment for Mycobacterium Abscessus Pulmonary Disease in People With or Without Cystic Fibrosis in the Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT) Adaptive Platform Trial (PHASE2)
• Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants
• Improvement of PPROM Management With Prophylactic Antimicrobial Therapy (iPROMPT) (PHASE4)
• Antibiotic Prophylaxis Versus Placebo in Alveolar Bone Grafting: A Randomized Controlled Trial (NA)
• Azithromycin and Ampicillin for Late PPROM (PHASE4)
• Microbial, Immune, and Metabolic Perturbations by Antibiotics (MIME Study) (PHASE1)
• Effects of Different Antibiotic Regimens in Preterm Premature Rupture of Membranes (NA)
• Effect of Antibiotics on Gut Microbiome and Plasma Metabolome (PHASE4)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Azithromycin and amoxicillin CI brief — competitive landscape report
• Azithromycin and amoxicillin updates RSS · CI watch RSS
• University of Alabama at Birmingham portfolio CI

Frequently asked questions about Azithromycin and amoxicillin

Related

• Drug class: All Macrolide and beta-lactam antibiotic combination drugs
• Target: All drugs targeting Bacterial 50S ribosomal subunit (azithromycin); bacterial cell wall peptidoglycan (amoxicillin)
• Manufacturer: University of Alabama at Birmingham — full pipeline
• Therapeutic area: All drugs in Infectious Disease
• Indication: Drugs for Bacterial infections susceptible to both azithromycin and amoxicillin
• Also known as: azithromycin, amoxicillin

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing