Azithromycin
Active ingredient · 2 therapeutic classes
Sold as AZASITE
- Drug class
- Macrolides
- Availability
- Prescription only
- Routes
- Oral, Intravenous, Ophthalmic
- Markets covered
- 3
- Products on record
- 108
- FDA reports (12 mo)
- 4,393
Overview
Plain-language summary, compiled from the cited regulatory records
Azithromycin is a macrolide antibacterial drug [1]. It is used to treat patients with mild to moderate infections caused by specific microorganisms [1]. These infections include conditions such as [1]: * Mild to moderate infections caused by susceptible strains of designated microorganisms.
Azithromycin is available under various brand names, including AZASITE [1].
In the past 12 months, there have been 4393 adverse event reports for azithromycin [2]. The most frequently reported issues include off-label use, perceived ineffectiveness of the drug, dyspnea, aggravation of a condition, and cough [2].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 45 | May 22, 2026 |
| CA Canada | Health Canada | 38 | June 1, 2026 |
| US United States | FDA | 25 | May 13, 2026 |
GBUnited Kingdom· MHRA
45 products
Uses
4 “Use in neonates”). Consideration should be given to official guidance on the appropriate use of antibacterial agents.
How to take
CACanada· Health Canada
38 products
Uses
ALTA-AZITHROMYCIN for Oral Administration ALTA-AZITHROMYCIN (azithromycin dihydrate tablets) for oral administration is indicated for treatment of mild to moderate infections caused by susceptible strains of the designated microorganisms in the following diseases and specific conditions.
As recommended dosages, durations of therapy and applicable patient populations vary among these infections, see 4 DOSAGE AND ADMINISTRATION for specific dosing recommendations. Because some strains are resistant to azithromycin, when applicable, appropriate culture and susceptibility tests should be initiated before treatment to determine the causative organism and its susceptibility to azithromycin.
Therapy with ALTA-AZITHROMYCIN may be initiated before results of these tests are known; once the results become available, antibiotic treatment should be adjusted accordingly.
Adults Pharyngitis and tonsillitis:
USUnited States· FDA
25 products
Uses
1 INDICATIONS AND USAGE Azithromycin is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below.
Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. 2 ) Limitation of Use: Azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors.
3 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria.
1 Adult Patients Acute bacterial exacerbations of chronic bronchitis due to Haemophilus influenzae , Moraxella catarrhalis, or Streptococcus pneumoniae . Acute bacterial sinusitis due to Haemophilus influenzae , Moraxella catarrhalis.
Drug interactions
Known interactions involving Azithromycin. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 504. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PL201620012 · revised May 22, 2026
- [2]Health Canada (DPD) · 02477610 · revised June 1, 2026
- [3]FDA DailyMed · 21c67de0-3a4e-ca… · revised May 13, 2026 [PDF]
- [4]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.