Drugs › Macrolide antimicrobial
Brand name · Azithromycin monohydrate
Azasite: adverse event reports filed with FDA
1,035 reports list it as a suspect or interacting product, 2007–2026. Class: Macrolide antimicrobial.
- 1,035
- reports as suspect product
- 0% of all reports · about 55 a year
- 8
- reports, 12 months to June 2026
- 22 in the 12 months before
- 7.1%
- marked serious by the reporter
- 82.7% across the class
- 0.7%
- record death among outcomes, as reported
- 7 reports · not verified by FDA
1,035 adverse event reports received by FDA list the brand name Azasite (azithromycin monohydrate) as a suspect or interacting product, from November 2007 to May 2026. A further 251 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 8 reports listed it, down 64% from 22 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 55 reports a year and 0% of the 20,646,523 reports in the database, and 2.1% of the reports for the macrolide antimicrobial class. How many people take it is not in the data, so a count is not a rate of occurrence.
The reactions recorded most often are no adverse event (40.6%), drug dose omission (31.2%) and product quality issue (26.3%). A report can list several reactions, so shares add to more than 100%; 139 different terms appear across these reports. No adverse event is recorded in 40.6% of these reports, with no counterpart in the median macrolide antimicrobial drug (0%).
7.1% of the reports are marked serious by the reporter (82.7% across the class); 0.7% record death among the outcomes and 1.4% record hospitalisation, as reported. 29.6% of the reports came from pharmacists, and the largest patient age group is 75 and over (9%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
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 Azasite reports recording the termmedian drug in macrolide antimicrobial
- No adverse eventno adverse event was reported40.6%420
- Drug dose omissiona dose was missed31.2%323
- Product quality issuea problem with the product itself26.3%272
- Inappropriate schedule of drug administrationthe medicine was taken at the wrong times20.1%208
- Eye irritationeye irritation16.3%169
- Off label useused for a purpose or in a way not on the label8.9%92
- Eye paineye pain8%83
- Ocular hyperaemiaa red eye7.1%73
- Drug prescribing errora prescribing mistake6.4%66
- Drug ineffectivethe medicine did not work as expected5.4%56
- Vision blurredblurred vision5%52
- Eye pruritus3.4%35
- Dry eyedry eye2.5%26
- Eye swellinga swollen eye2.4%25
- Wrong technique in drug usage processthe medicine was used in the wrong way2%21
- Incorrect storage of drug1.9%20
- Overdosea dose above the recommended amount1.9%20
- Expired drug administered1.6%17
- Incorrect dose administeredthe wrong dose was given1.6%17
- Underdoseless than the intended dose1.5%16
- Lacrimation increasedwatery eyes1.4%15
- Drug administration errora mistake in giving the medicine1.3%13
- Eye burns1.1%11
- Eye discharge1.1%11
- Painpain, site not specified1.1%11
- Hypersensitivityan allergic-type reaction1%10
Top 30 of 139 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
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 92.6% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Blepharitis | 92 | 8.9% |
| Eye infection | 45 | 4.3% |
| Dry eye | 43 | 4.2% |
| Conjunctivitis | 16 | 1.5% |
| Conjunctivitis bacterial | 15 | 1.4% |
| Infection | 11 | 1.1% |
The indication field is filled in by the reporter and is often blank; shares are of all 1,035 reports.
In context
| Measure | Azasite | Macrolide antimicrobial | All reports |
|---|---|---|---|
| Reports as suspect product | 1,035 | 48,453 | 20,646,523 |
| Share of that pool | — | 2.1% | 0% |
| Reports, latest 12 months | 8 | — | 1,332,454 |
| Marked serious | 7.1% | 82.7% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 7 | 72 | 91 |
| Hospitalisation recorded, per 1,000 reports | 14 | 351 | 213 |
| Consumer-filed share | 23.5% | 20.8% | 45.8% |
| Top term, share of reports | No adverse event 40.6% | median 0% | 0.8% |
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
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Clarithromycin | generic | 21,814 | 1,044 | 95% |
| Azithromycin | generic | 17,500 | 2,070 | 82.5% |
| Zithromax | brand | 7,379 | 130 | 56.2% |
| Azithromycin dihydrate | generic | 725 | 68 | 97.7% |
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.
Questions about Azasite reports
How many adverse event reports has FDA received for Azasite?
1,035 reports list Azasite as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 8 of them arrived in the latest 12 months. Another 251 list it only as a concomitant medication.
What reactions are recorded in Azasite reports?
no adverse event (40.6%), drug dose omission (31.2%), product quality issue (26.3%), inappropriate schedule of drug administration (20.1%) and eye irritation (16.3%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Azasite was responsible.
How serious are the reports?
7.1% are marked serious by the reporter. Among the outcomes recorded, 0.7% of reports include death and 1.4% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
pharmacist (29.6%), consumer or non-health professional (23.5%) and physician (21.4%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Azasite rising?
8 reports in the 12 months to June 2026, down 64% from 22 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Azasite was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Azasite?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
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 Azasite as a suspect or interacting product; reports listing it only as a concomitant medication (251) 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.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.