Azithromycin Side Effects: Common, Serious & FDA Warnings
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Quick answer
Based on 58,000+ FDA adverse event reports, the most-reported azithromycin reactions include dyspnoea, nausea, and pain. No active recalls are on record. The FDA-approved label does not carry a boxed warning.
For information only. MedivaScan summarizes public FDA data and is not medical advice. Consult a healthcare professional before changing any medication. If you experience a serious reaction, contact your doctor or call 911.
Common Side Effects of Azithromycin
The most-reported reactions in the FDA Adverse Event Reporting System (FAERS) for azithromycin. Percentages reflect the share of reports mentioning each reaction; a single report may include multiple reactions. Reports indicate co-occurrence, not causation.
| Reaction | Reports | % of total |
|---|---|---|
| Dyspnoea | 4,508 | 7.7% |
| Nausea | 3,368 | 5.8% |
| Pain | 3,235 | 5.6% |
| Pneumonia | 3,099 | 5.3% |
| Cough | 3,022 | 5.2% |
| Drug Hypersensitivity | 2,964 | 5.1% |
| Diarrhoea | 2,887 | 5.0% |
| Fatigue | 2,806 | 4.8% |
| Headache | 2,540 | 4.4% |
| Pyrexia | 2,327 | 4.0% |
Serious Outcomes and FDA Warnings
FAERS reports flagged with a serious outcome (death, hospitalization, life-threatening, disability, or congenital anomaly), plus reactions surfaced in the FDA-approved label's Warnings section. Reports indicate co-occurrence, not causation.
| Outcome flag | Reports | % of total |
|---|---|---|
| Serious reports (any flag) | — | — |
| Hospitalization | — | — |
From the FDA-approved label, Section 5.1: Hypersensitivity
Serious allergic reactions, including angioedema, anaphylaxis, and dermatologic reactions including Acute Generalized Exanthematous Pustulosis (AGEP), Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported in patients on azithromycin therapy. [see ] Fatalities have been reported. Cases of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) have also been reported. Despite initially successful symptomatic treatment of the allergic symptoms, when symptomatic therapy was discontinued, the allergic symptoms recurred soon thereafter in some patients without further azithromycin exposure.Show full Section 5.1
These patients required prolonged periods of observation and symptomatic treatment. The relationship of these episodes to the long tissue half-life of azithromycin and subsequent prolonged exposure to antigen is presently unknown. If an allergic reaction occurs, the drug should be discontinued and appropriate therapy should be instituted. Physicians should be aware that allergic symptoms may reappear when symptomatic therapy has been discontinued.
From the FDA-approved label, Section 5.4: QT Prolongation
Prolonged cardiac repolarization and QT interval, imparting a risk of developing cardiac arrhythmia and torsades de pointes, have been seen with treatment with macrolides, including azithromycin. Cases of torsades de pointes have been spontaneously reported during postmarketing surveillance in patients receiving azithromycin. Providers should consider the risk of QT prolongation which can be fatal when weighing the risks and benefits of azithromycin for at-risk groups including: • patients with known prolongation of the QT interval, a history of torsades de pointes, congenital long QT syndrome, bradyarrhythmias or uncompensated heart failure • patients on drugs known to prolong the QT interval • patients with ongoing proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia, and in patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.Show full Section 5.4
Elderly patients may be more susceptible to drug-associated effects on the QT interval.
Azithromycin Recalls
FDA enforcement actions matched to azithromycin via openFDA's structured generic_name field and the NDC bridge. Ongoing recalls are listed below (verify on FDA →); closed recalls are grouped in the disclosure that follows.
No recalls are on record for this drug in the FDA enforcement database.
Show 2 closed recalls (2014 to 2022)
Includes resolved and terminated recalls matched to azithromycin. Most recent first.
| Date | Reason | Class | Quantity | Status |
|---|---|---|---|---|
| 2022-06-15 | cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office | Class II | 13 carton/10 vials each | Terminated |
| 2014-01-22 | Failed Impurities/Degradation Specifications: Pfizer is recalling certain lots due to out of specification results for azithromycin N-oxide degradant. Pfizer Inc. | Class III | 101,681 Vials | Terminated |
Azithromycin Shortages
FDA-listed shortages of azithromycin products. Strength and dosage-form level detail.
No active or recent shortages of azithromycin are listed. We refresh this view daily.
Is Azithromycin Safe?
Azithromycin is FDA-approved and the label does not carry a boxed warning. The label's Warnings and Precautions section covers hypersensitivity (Section 5.1), hepatotoxicity (Section 5.2), infantile hypertrophic pyloric stenosis (ihps) (Section 5.3), qt prolongation (Section 5.4), cardiovascular death (Section 5.5), clostridioides difficile -associated diarrhea (Section 5.6), exacerbation of myasthenia gravis (Section 5.7), use in sexually transmitted infections (Section 5.8), development of drug-resistant bacteria (Section 5.9).
As with any prescription, the assessment of safety is individual; consult a clinician about your own risk profile.
FDA-Approved Indications
Azithromycin is FDA-approved for use in the condition categories below. The FDA-approved label’s Indications and Usage section is shown verbatim.
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. [see Dosage and Administration (2) ] Azithromycin is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria: • Acute bacterial exacerbations of chronic bronchitis in adults () • Acute bacterial sinusitis in adults () • Uncomplicated skin and skin structure infections in adults () • Urethritis and cervicitis in adults () • Genital ulcer disease in men () • Acute otitis media in pediatric patients (6 months of age and older) ( 1.Show full Indications and Usage
2 ) • Community-acquired pneumonia in adults and pediatric patients (6 months of age and older) (, 1.2 ) • Pharyngitis/tonsillitis in adults and pediatric patients (2 years of age and older) (, 1.2 ) 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. ( 1.3 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin tablets and other antibacterial drugs, azithromycin tablets should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. () 1.1 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. or Streptococcus pneumoniae . • Community-acquired pneumonia due to Chlamydophila pneumoniae , Haemophilus influenzae , Mycoplasma pneumoniae, or Streptococcus pneumoniae in patients appropriate for oral therapy. • Pharyngitis/tonsillitis caused by Streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy. • Uncomplicated skin and skin structure infections due to Staphylococcus aureus , Streptococcus pyogenes , or Streptococcus agalactiae . • Urethritis and cervicitis due to Chlamydia trachomatis or Neisseria gonorrhoeae . • Genital ulcer disease in men due to Haemophilus ducreyi (chancroid). Due to the small number of women included in clinical trials, the efficacy of azithromycin in the treatment of chancroid in women has not been established. 1.2 Pediatric Patients [see and ] • Acute otitis media (>6 months of age) caused by Haemophilus influenzae, Moraxella catarrhalis , or Streptococcus pneumoniae. • Community-acquired pneumonia (>6 months of age) due to Chlamydophila pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae , or Streptococcus pneumoniae in patients appropriate for oral therapy. • Pharyngitis/tonsillitis (>2 years of age) caused by Streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy. 1.3 Limitations 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 such as any of the following: • patients with cystic fibrosis, • patients with nosocomial infections, • patients with known or suspected bacteremia, • patients requiring hospitalization, • elderly or debilitated patients, or • patients with significant underlying health problems that may compromise their ability to respond to their illness (including immunodeficiency or functional asplenia). 1.4 Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin tablets and other antibacterial drugs, azithromycin tablets should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Frequently Asked Questions
What are the most-reported side effects of azithromycin?
Dyspnoea, nausea, and pain are among the most-reported reactions in FDA FAERS data for azithromycin. The full ranking, with reaction counts and the share of total reports, is in the Common Side Effects table above. Reports indicate co-occurrence, not causation; consult a clinician about your specific case.
Has azithromycin been recalled?
Yes. Azithromycin has closed recalls on record in the FDA enforcement database; no recalls are currently active. Reasons are dominated by CGMP deviations and contamination or foreign material. See the recalls table on this page for dates, firm names, and lot quantities.
What do FDA recall classes mean?
Class I means a reasonable probability of serious adverse health consequences or death. Class II means temporary or medically reversible adverse health consequences with remote probability of serious harm. Class III means use of the product is unlikely to cause adverse health consequences. The class assignment is the FDA's, not the manufacturer's.
Data Sources & Methodology
How each section of this page is sourced, and how often the data is refreshed.
| Source | Endpoint | Refresh |
|---|---|---|
| FAERS reactions | openFDA /drug/event.json count API. Aggregated per drug per reaction term; we do not store individual reports. | Daily |
| Recalls | openFDA /drug/enforcement.json. Drugs matched via three confidence-tracked strategies: structured generic name (HIGH), NDC code bridge (MEDIUM), text token parse (LOW). Only HIGH and MEDIUM matches surface here. | 6 hours |
| Shortages | FDA Drug Shortages list. | Daily |
| Boxed warnings & label sections | openFDA /drug/label.json. Labels are stable; monthly cadence is sufficient. | Monthly |
| Condition categories | Synonym-mapped from drug_labels.indications. Methodology at /methodology/. | Per-drug |
What we do not do. We do not invent, paraphrase, or extrapolate drug claims. Every figure on this page comes from a query against an openFDA endpoint. If the data is unavailable, the section gracefully omits rather than filling the space with editorial guesswork.