Azithromycin Anhydrous: Side Effects, Uses & Monitoring
Azithromycin for oral suspension USP is indicated for the treatment of patients with mild to moderate infections (pneumonia: see WARNINGS ) caused by susceptible strains of the designated microorganisms in the specific c
- Data source
- FDA labeling via NIH DailyMed (label 5c756d25…)
- Label version
- current
- Last reviewed
- 2026
Reported adverse reactions
Reactions listed in current FDA labeling, with the highest frequency reported across summarized placebo-controlled trials.
| Adverse reaction (as reported in labeling) | Reported frequency* |
|---|---|
| 1 day | 4.9% |
| 3 day | 2.6% |
| 5 day | 1.8% |
*Highest percentage reported for the active moiety across placebo-controlled trial tables in current FDA labeling. Values reflect trial reporting, not your individual risk.
Labeled uses (from FDA prescribing information)
Azithromycin for oral suspension USP is indicated for the treatment of patients with mild to moderate infections (pneumonia: see WARNINGS ) caused by susceptible strains of the designated microorganisms in the specific conditions listed below. As recommended dosages, durations of therapy and applicable patient populations vary among these infections, please see DOSAGE AND ADMINISTRATION for specific dosing recommendations. Adults Acute bacterial exacerbations of chronic obstructive pulmonary disease due to Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae. Acute bacterial sinusitis due to Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae. Community-acquired pneumonia due to Chlamydophila pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae or Streptococcus pneumoniae in patients appropriate for oral therapy. NOTE: 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 such as any of the following: patients with cystic fibrosis, patients with nosocomially acquired infections, patients with known or suspected bacteremia, pa…
Conditions associated with Azithromycin Anhydrous in labeling
COPD
A group of progressive lung diseases, including emphysema and chronic bronchitis, that cause airflow obstructi...
Cystic Fibrosis
A genetic disorder that causes thick, sticky mucus to build up in the lungs, pancreas, and other organs, leadi...
Pneumonia
Infection of the lung tissue that can cause cough, fever, chills, and difficulty breathing. Can be caused by b...
Rheumatic fever
Rheumatic fever is a medical condition that may be associated with various symptoms and signs....
Sinus Infection
Inflammation of the sinuses, often viral or bacterial, causing facial pressure, congestion, and headache....
Tonsillitis
Inflammation of the tonsils, often caused by viral or bacterial infection, causing sore throat, fever, and swo...
Frequently Asked Questions
What is Azithromycin Anhydrous used for?
FDA labeling lists the approved uses shown above under "Labeled uses." This summary is informational; only a qualified prescriber can determine whether a medication is appropriate for you.
What are the most commonly reported side effects of Azithromycin Anhydrous?
The table above shows adverse reactions and the highest frequencies reported in placebo-controlled trials summarized in current FDA labeling for Azithromycin Anhydrous. Individual risk varies.
Does Azithromycin Anhydrous require lab monitoring?
Monitoring needs vary. Ask your healthcare provider whether any lab tests apply while taking Azithromycin Anhydrous.
Where does this information come from?
All clinical facts on this page were extracted from the current FDA-registered product labeling for this ingredient, published by manufacturers through NIH DailyMed. See the source link below.
Medical disclaimer: Educational content extracted from public FDA labeling. Not medical advice. Always consult a qualified healthcare professional before starting, stopping, or changing any medication.