82/100 · Critical
Manufactured by AiPing Pharmaceutical, Inc.
Azithromycin Adverse Events Show High Seriousness and Diverse Reactions
88,134 FDA adverse event reports analyzed
Last updated: 2026-05-12
AZITHROMYCIN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by AiPing Pharmaceutical, Inc.. Based on analysis of 88,134 FDA adverse event reports, AZITHROMYCIN has a safety score of 82 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for AZITHROMYCIN include OFF LABEL USE, DRUG INEFFECTIVE, DYSPNOEA, NAUSEA, PAIN. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for AZITHROMYCIN.
Azithromycin has a safety concern score of 82 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 88,134 adverse event reports for this medication, which is primarily manufactured by Aiping Pharmaceutical, Inc..
The most commonly reported adverse events include Off Label Use, Drug Ineffective, Dyspnoea. Of classified reports, 78.6% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. High percentage of serious adverse events (78.6%) indicates significant safety concerns.
Diverse range of reactions, including respiratory, gastrointestinal, and cardiovascular issues. Common reactions like nausea, pain, and cough are frequently reported.
Patients taking Azithromycin should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Azithromycin can interact with other drugs, leading to adverse effects. Warnings include drug interactions and potential exacerbation of certain conditions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Azithromycin received a safety concern score of 82/100 (high concern). This is based on a 78.6% serious event ratio across 37,352 classified reports. The score accounts for 88,134 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Female: 20,280, Male: 13,838, Unknown: 93. The most frequently reported age groups are age 65 (637 reports), age 60 (599 reports), age 61 (539 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 37,352 classified reports for AZITHROMYCIN:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Azithromycin can interact with other drugs, leading to adverse effects. Warnings include drug interactions and potential exacerbation of certain conditions.
If you are taking Azithromycin, here are important things to know. The most commonly reported side effects include off label use, drug ineffective, dyspnoea, nausea, pain. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Always follow prescribed dosages and instructions from healthcare providers. Report any serious adverse events to the FDA or your healthcare provider immediately. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
Regulatory oversight is ongoing, with a focus on monitoring serious adverse events and ensuring proper use of the drug.
The FDA has received approximately 88,134 adverse event reports associated with Azithromycin. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Azithromycin include Off Label Use, Drug Ineffective, Dyspnoea, Nausea, Pain. By volume, the top reported reactions are: Off Label Use (3,915 reports), Drug Ineffective (3,661 reports), Dyspnoea (3,059 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Azithromycin.
Out of 37,352 classified reports, 29,377 (78.6%) were classified as serious and 7,975 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Azithromycin break down by patient sex as follows: Female: 20,280, Male: 13,838, Unknown: 93. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Azithromycin adverse events are: age 65: 637 reports, age 60: 599 reports, age 61: 539 reports, age 64: 530 reports, age 63: 524 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Azithromycin adverse event reports is Aiping Pharmaceutical, Inc.. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Azithromycin include: Pneumonia, Cough, Diarrhoea, Fatigue, Headache. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Azithromycin to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Azithromycin has a safety concern score of 82 out of 100 (high concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. High percentage of serious adverse events (78.6%) indicates significant safety concerns.
Key safety signals identified in Azithromycin's adverse event data include: High number of serious reactions (29,377 out of 37,352, 78.6%). Multiple respiratory issues including pneumonia, wheezing, and pulmonary embolism. Cardiovascular concerns such as hypotension and QT prolongation. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Azithromycin can interact with other drugs, leading to adverse effects. Warnings include drug interactions and potential exacerbation of certain conditions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Azithromycin.
Always follow prescribed dosages and instructions from healthcare providers. Report any serious adverse events to the FDA or your healthcare provider immediately.
Azithromycin has 88,134 adverse event reports on file with the FDA. Diverse range of reactions, including respiratory, gastrointestinal, and cardiovascular issues. The volume of reports for Azithromycin reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with a focus on monitoring serious adverse events and ensuring proper use of the drug. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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