Zithromax
A short-course antibiotic for respiratory and other infections.
Where Azithromycin is approved
All regulators →Of the three regulators tracked here, the first to approve Azithromycin was the US, on 1 Nov 1991. It is approved in 2 of the 3 regulators tracked here.
- 1 EU orphan designation, most recently for prevention of bronchopulmonary dysplasia (14 Jan 2022, positive)
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
What health systems spend on Azithromycin
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Azithromycin works
All drug targets →- Bacterial 70S ribosome inhibitor InhibitorChEMBL only
- Acute otitis mediaPhase 3
- COVID-19Phase 3
- COVID-19–associated multisystem inflammatory syndrome in childrenPhase 3
- Helicobacter pylori infectious diseasePhase 3
- Intraventricular hemorrhagePhase 3
- Mycobacterium avium complex diseasePhase 3
- Orthocoronavirinae infectious diseasePhase 3
- Orthomyxoviridae infectious diseasePhase 3
- Respiratory tract infectionPhase 3
- Ureaplasma urethritisPhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL529, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3), ligand 6510, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
Patient leaflets for Azithromycin
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 8 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Azithromycin
- ChEMBL
- CHEMBL529
- DrugBank
- DB00207
- PubChem CID
- 447043
- CAS number
- 83905-01-5
- FDA UNII
- F94OW58Y8V
- Wikidata
- Q165399
- Wikipedia
- Azithromycin
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
What Zithromax is used for
ZITHROMAX is a macrolide antibacterial drug indicated for the treatment of the following infections caused by designated susceptible microorganisms: • Community-acquired pneumonia in adults ( 1.1 ) • Pelvic inflammatory disease in adults ( 1.2 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZITHROMAX and other antibacterial drugs, ZITHROMAX should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. ( 1.3 ) 1.1 Community-Acquired Pneumonia ZITHROMAX is indicated for the treatment of adult patients with community-acquired pneumonia due to the following susceptible microorganisms: Chlamydophila pneumoniae, Haemophilus influenzae, Legionella pneumophila, Moraxella catarrhalis, Mycoplasma pneumoniae, Staphylococcus aureus, or Streptococcus pneumoniae in patients who require initial in…
How it works
12.1 Mechanism of Action Azithromycin is a macrolide antibacterial drug [see Microbiology (12.4) ]
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How this page is built
The facts on this page are pulled directly from official U.S. FDA datasets — they are not written from memory. Each field below names the dataset it came from, so you can check it yourself.
- FDA Drug Label (openFDA) ↗ Indications, mechanism of action and pharmacologic class
- Drugs@FDA ↗ First FDA approval date and the company holding the application
- FDA Drug Shortage Database ↗ Current US supply / shortage status
Plain-English summaries and drug-class explainers are written and reviewed by Sreepriya Prasannan (MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany). Data is retrieved automatically from the sources above and cross-checked with AI-assisted verification (Anthropic's Claude) — brand and generic names are matched against the exact FDA product record so that a combination product or a different formulation cannot be mistaken for the drug on this page. An editor reviews the result before publication. We describe this in full in our editorial standards and corrections policy. The FDA data on this page was last retrieved on 4 Oct 2026. How every register is built: methodology · fixes we have made: corrections log.