78/100 · Elevated
Manufactured by Aurobindo Pharma Limited
Highly Reported Adverse Reactions for Azithromycin Dihydrate
126,693 FDA adverse event reports analyzed
Last updated: 2026-05-12
AZITHROMYCIN DIHYDRATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Aurobindo Pharma Limited. Based on analysis of 126,693 FDA adverse event reports, AZITHROMYCIN DIHYDRATE has a safety score of 78 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 DIHYDRATE 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 DIHYDRATE.
Azithromycin Dihydrate has a safety concern score of 78 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 126,693 adverse event reports for this medication, which is primarily manufactured by Aurobindo Pharma Limited.
The most commonly reported adverse events include Off Label Use, Drug Ineffective, Dyspnoea. Of classified reports, 74.9% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Serious reactions such as pneumonia, dyspnoea, and renal failure are frequently reported.
A significant number of reports involve off-label use and drug ineffectiveness. The majority of reactions are non-serious, but serious reactions are concerning.
Patients taking Azithromycin Dihydrate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Azithromycin dihydrate may interact with other drugs, leading to adverse effects. Warnings include drug interactions and potential exacerbation of respiratory conditions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Azithromycin Dihydrate received a safety concern score of 78/100 (high concern). This is based on a 74.9% serious event ratio across 55,390 classified reports. The score accounts for 126,693 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: 31,269, Male: 19,695, Unknown: 169. The most frequently reported age groups are age 65 (924 reports), age 60 (805 reports), age 62 (741 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 55,390 classified reports for AZITHROMYCIN DIHYDRATE:
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 dihydrate may interact with other drugs, leading to adverse effects. Warnings include drug interactions and potential exacerbation of respiratory conditions.
If you are taking Azithromycin Dihydrate, 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. Follow prescribed dosages and indications strictly to avoid off-label use and drug ineffectiveness. Monitor for signs of serious reactions such as dyspnoea and renal failure, and report any adverse events to healthcare providers. 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.
The FDA continues to monitor the safety of azithromycin dihydrate, and regulatory actions may be taken based on ongoing data analysis.
The FDA has received approximately 126,693 adverse event reports associated with Azithromycin Dihydrate. 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 Dihydrate include Off Label Use, Drug Ineffective, Dyspnoea, Nausea, Pain. By volume, the top reported reactions are: Off Label Use (4,747 reports), Drug Ineffective (4,697 reports), Dyspnoea (4,325 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 Dihydrate.
Out of 55,390 classified reports, 41,511 (74.9%) were classified as serious and 13,879 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 Dihydrate break down by patient sex as follows: Female: 31,269, Male: 19,695, Unknown: 169. 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 Dihydrate adverse events are: age 65: 924 reports, age 60: 805 reports, age 62: 741 reports, age 64: 739 reports, age 61: 736 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 Dihydrate adverse event reports is Aurobindo Pharma Limited. 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 Dihydrate include: Pneumonia, Drug Hypersensitivity, Cough, Diarrhoea, Fatigue. 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 Dihydrate 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 Dihydrate has a safety concern score of 78 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. Serious reactions such as pneumonia, dyspnoea, and renal failure are frequently reported.
Key safety signals identified in Azithromycin Dihydrate's adverse event data include: Pneumonia and dyspnoea are the most common serious reactions.. Off-label use and drug ineffectiveness are significant safety signals.. Renal failure and acute kidney injury are also notable safety concerns.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Azithromycin dihydrate may interact with other drugs, leading to adverse effects. Warnings include drug interactions and potential exacerbation of respiratory conditions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Azithromycin Dihydrate.
Follow prescribed dosages and indications strictly to avoid off-label use and drug ineffectiveness. Monitor for signs of serious reactions such as dyspnoea and renal failure, and report any adverse events to healthcare providers.
Azithromycin Dihydrate has 126,693 adverse event reports on file with the FDA. A significant number of reports involve off-label use and drug ineffectiveness. The volume of reports for Azithromycin Dihydrate reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of azithromycin dihydrate, and regulatory actions may be taken based on ongoing data analysis. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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