70/100 · Elevated
Manufactured by Aurobindo Pharma Limited
Moderate Safety Concerns with Azithromycin Monohydrate
89,541 FDA adverse event reports analyzed
Last updated: 2026-05-12
AZITHROMYCIN MONOHYDRATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Aurobindo Pharma Limited. Based on analysis of 89,541 FDA adverse event reports, AZITHROMYCIN MONOHYDRATE has a safety score of 70 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 MONOHYDRATE 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 MONOHYDRATE.
Azithromycin Monohydrate has a safety concern score of 70 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 89,541 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, 76.6% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The majority of adverse events are non-serious, but serious events such as pneumonia and renal injury are reported.
Drug interactions and ineffective drug performance are common issues. A significant number of reports involve respiratory and gastrointestinal symptoms.
Patients taking Azithromycin Monohydrate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Azithromycin Monohydrate can interact with other drugs, and its use in unapproved indications may lead to ineffectiveness or adverse reactions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Azithromycin Monohydrate received a safety concern score of 70/100 (elevated concern). This is based on a 76.6% serious event ratio across 38,727 classified reports. The score accounts for 89,541 total adverse event reports and 100 distinct reaction types. This elevated score indicates a notable proportion of serious adverse events and warrants careful monitoring.
Adverse event reports by sex: Female: 21,114, Male: 14,187, Unknown: 223. The most frequently reported age groups are age 65 (645 reports), age 60 (609 reports), age 61 (589 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 38,727 classified reports for AZITHROMYCIN MONOHYDRATE:
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 Monohydrate can interact with other drugs, and its use in unapproved indications may lead to ineffectiveness or adverse reactions.
If you are taking Azithromycin Monohydrate, 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 indications for Azithromycin Monohydrate. Report any adverse reactions to the FDA's MedWatch program. 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 Monohydrate, and healthcare providers should be aware of potential serious adverse events and drug interactions.
The FDA has received approximately 89,541 adverse event reports associated with Azithromycin Monohydrate. 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 Monohydrate include Off Label Use, Drug Ineffective, Dyspnoea, Nausea, Pain. By volume, the top reported reactions are: Off Label Use (4,036 reports), Drug Ineffective (3,748 reports), Dyspnoea (3,118 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 Monohydrate.
Out of 38,727 classified reports, 29,647 (76.6%) were classified as serious and 9,080 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 Monohydrate break down by patient sex as follows: Female: 21,114, Male: 14,187, Unknown: 223. 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 Monohydrate adverse events are: age 65: 645 reports, age 60: 609 reports, age 61: 589 reports, age 64: 541 reports, age 63: 540 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 Monohydrate 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 Monohydrate 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 Monohydrate 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 Monohydrate has a safety concern score of 70 out of 100 (elevated 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. The majority of adverse events are non-serious, but serious events such as pneumonia and renal injury are reported.
Key safety signals identified in Azithromycin Monohydrate's adverse event data include: Pneumonia and renal injury are key safety signals, with high report volumes.. Drug ineffectiveness and drug intolerance are frequent.. Respiratory and gastrointestinal symptoms are commonly reported.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Azithromycin Monohydrate can interact with other drugs, and its use in unapproved indications may lead to ineffectiveness or adverse reactions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Azithromycin Monohydrate.
Always follow prescribed dosages and indications for Azithromycin Monohydrate. Report any adverse reactions to the FDA's MedWatch program.
Azithromycin Monohydrate has 89,541 adverse event reports on file with the FDA. Drug interactions and ineffective drug performance are common issues. The volume of reports for Azithromycin Monohydrate reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of Azithromycin Monohydrate, and healthcare providers should be aware of potential serious adverse events and drug interactions. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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