Azithromycin: adverse event reports filed with FDA

17,500

reports as suspect product

0.1% of all reports · about 778 a year

2,070

reports, 12 months to June 2026

2,343 in the 12 months before

82.5%

marked serious by the reporter

82.7% across the class

9.2%

record death among outcomes, as reported

1,608 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Azithromycin reports recording the termmedian drug in macrolide antimicrobial

1. Off label useused for a purpose or in a way not on the label15.6%2,734
2. Drug ineffectivethe medicine did not work as expected15%2,629
3. Dyspnoeashortness of breath7.7%1,343
4. Condition aggravatedthe condition being treated got worse6.4%1,127
5. Nauseafeeling sick6.1%1,072
6. Diarrhoealoose or frequent stools5.1%900
7. Wheezingwheezing4.8%837
8. Asthmaasthma4.8%834
9. Product use in unapproved indicationused for a purpose not on the label4.6%807
10. Coughcough4.6%805
11. Drug interactionan interaction between medicines4.3%759
12. Drug hypersensitivityan allergic-type reaction to a medicine4.3%751
13. Pyrexiafever4.3%747
14. Headachehead pain4.2%741
15. Therapeutic product effect incomplete3.9%687
16. Vomitingbeing sick3.9%678
17. Drug ineffective for unapproved indication3.6%638
18. Maternal exposure during pregnancythe mother took the medicine during pregnancy3.6%623
19. Pneumonialung infection3.3%583
20. Rashskin rash3.2%563
21. Malaisegeneral feeling of being unwell3.1%549
22. Weight decreasedweight loss3.1%541
23. Painpain, site not specified3.1%538
24. Drug intolerancethe medicine was not tolerated3%520
25. Full blood count abnormal2.9%503
26. Abdominal painstomach or belly pain2.8%493
27. Obstructive airways disorder2.8%486
28. Pruritusitching2.7%468
29. Fatiguetiredness2.6%459
30. Electrocardiogram QT prolongeda QT prolongation on the ECG2.6%452

Top 30 of 2,074 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 5 drugs in the macrolide antimicrobial class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 48,453 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 43.1% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 17,500 reports.

Drugs most often listed in the same reports

Other products listed in reports where Azithromycin is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the macrolide antimicrobial class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Azithromycin as a suspect or interacting product; reports listing it only as a concomitant medication (23,145) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.