Pharmacologic class (EPC) · 5 drug pages

Macrolide antimicrobial: adverse event reports filed with FDA

48,453 reports list a drug in this class as a suspect or interacting product, 2004–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

48,453
reports across the class: 0.2% of all reports; 3,320
reports, 12 months to June 2026: 3,614 in the 12 months before; 82.7%
marked serious by the reporter: 57.4% across all reports; 5
drugs with a page: brand and generic names counted separately

Macrolide antimicrobial is a pharmacologic class (an FDA Established Pharmacologic Class) with 5 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 48,453 adverse event reports received by FDA, 0.2% of the database, from January 2004 to June 2026.

3,320 reports arrived in the 12 months to June 2026, close to the 3,614 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 82.7% of the class's reports are marked serious, 7.2% record death among the outcomes and 35.1% record hospitalisation, as reported.

Across the class the reactions recorded most often are drug ineffective (11.3%), off label use (9.1%) and drug interaction (7.9%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is 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."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
Clarithromycin	generic	21,814	1,044	95%	Drug interaction
Azithromycin	generic	17,500	2,070	82.5%	Off label use
ZithromaxAzithromycin dihydrate	brand	7,379	130	56.2%	Drug hypersensitivity
AzasiteAzithromycin monohydrate	brand	1,035	8	7.1%	No adverse event
Azithromycin dihydrate	generic	725	68	97.7%	Drug ineffective

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."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Drug ineffectivethe medicine did not work as expected11.3%5,479
Off label useused for a purpose or in a way not on the label9.1%4,399
Drug interactionan interaction between medicines7.9%3,852
Drug hypersensitivityan allergic-type reaction to a medicine6.9%3,341
Nauseafeeling sick6.5%3,170
Dyspnoeashortness of breath6.3%3,074
Diarrhoealoose or frequent stools5.6%2,698
Headachehead pain4.5%2,163
Malaisegeneral feeling of being unwell4.3%2,066
Vomitingbeing sick4.2%2,045
Pyrexiafever4.2%2,032
Condition aggravatedthe condition being treated got worse3.7%1,806
Rashskin rash3.7%1,797
Coughcough3.2%1,563
Abdominal painstomach or belly pain3%1,457
Macular degenerationa disease of the central retina2.9%1,423
Dizzinesslight-headedness or unsteadiness2.9%1,395
Painpain, site not specified2.7%1,328
Pruritusitching2.7%1,327
Hypersensitivityan allergic-type reaction2.7%1,325
Fatiguetiredness2.7%1,314
Product use in unapproved indicationused for a purpose not on the label2.7%1,297
Asthmaasthma2.6%1,261
Pneumonialung infection2.6%1,246
Wheezingwheezing2.6%1,239

Solid bar: share of all class reports. Hollow bar: the median share across the 5 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death7.2%3,470

Life-threatening7.4%3,572

Hospitalisation (initial or prolonged)35.1%17,026

Disability3.5%1,712

Congenital anomaly0.6%312

Other serious58.9%28,518

Not serious17.3%8,373

Patient age

Under 21.3%610

2 to 114.3%2,106

12 to 172.2%1,065

18 to 4417.5%8,491

45 to 6420.8%10,066

65 to 7413.3%6,425

75 and over11.8%5,736

Age not given28.8%13,954

Who reported

Physician27.7%13,416

Pharmacist8.2%3,993

Other health professional38.5%18,666

Lawyer0.2%121

Consumer or non-health professional20.8%10,092

Not given4.5%2,165

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Macrolide antimicrobial reports

Which drugs are in the Macrolide antimicrobial class on this site?

Clarithromycin, Azithromycin, Zithromax, Azasite and Azithromycin dihydrate. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

48,453 reports through June 2026, 3,320 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

drug ineffective (11.3%), off label use (9.1%), drug interaction (7.9%), drug hypersensitivity (6.9%) and nausea (6.5%).

Can the members table be used to rank the drugs?

No. 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." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. 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 class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. 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.