85/100 · Critical
Manufactured by Actavis Pharma, Inc.
Clarithromycin Adverse Events: High Seriousness and Diverse Reactions
66,659 FDA adverse event reports analyzed
Last updated: 2026-05-12
CLARITHROMYCIN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Actavis Pharma, Inc.. Based on analysis of 66,659 FDA adverse event reports, CLARITHROMYCIN has a safety score of 85 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 CLARITHROMYCIN include DRUG INTERACTION, DRUG INEFFECTIVE, NAUSEA, DYSPNOEA, DIARRHOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CLARITHROMYCIN.
Clarithromycin has a safety concern score of 85 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 66,659 adverse event reports for this medication, which is primarily manufactured by Actavis Pharma, Inc..
The most commonly reported adverse events include Drug Interaction, Drug Ineffective, Nausea. Of classified reports, 92.0% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Clarithromycin reports show a high percentage of serious adverse events, with dyspnoea and pneumonia among the most common.
The drug is frequently reported to cause gastrointestinal issues, including nausea and diarrhoea. Drug interactions and ineffective drug performance are also significant concerns.
Patients taking Clarithromycin should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Clarithromycin can interact with various drugs, leading to potential adverse effects. It is important to inform healthcare providers of all medications being taken. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Clarithromycin received a safety concern score of 85/100 (high concern). This is based on a 92.0% serious event ratio across 33,246 classified reports. The score accounts for 66,659 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: 17,979, Male: 11,950, Unknown: 112. The most frequently reported age groups are age 67 (568 reports), age 71 (546 reports), age 65 (538 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 33,246 classified reports for CLARITHROMYCIN:
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.
Clarithromycin can interact with various drugs, leading to potential adverse effects. It is important to inform healthcare providers of all medications being taken.
If you are taking Clarithromycin, here are important things to know. The most commonly reported side effects include drug interaction, drug ineffective, nausea, dyspnoea, diarrhoea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Inform your healthcare provider of all medications and supplements you are taking to avoid potential drug interactions. Be aware of the common side effects and seek medical attention if they worsen or persist. 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 closely monitors clarithromycin due to its high rate of serious adverse events. Patients should report any new symptoms to their healthcare provider immediately.
The FDA has received approximately 66,659 adverse event reports associated with Clarithromycin. 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 Clarithromycin include Drug Interaction, Drug Ineffective, Nausea, Dyspnoea, Diarrhoea. By volume, the top reported reactions are: Drug Interaction (2,905 reports), Drug Ineffective (2,476 reports), Nausea (2,213 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Clarithromycin.
Out of 33,246 classified reports, 30,594 (92.0%) were classified as serious and 2,652 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 Clarithromycin break down by patient sex as follows: Female: 17,979, Male: 11,950, Unknown: 112. 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 Clarithromycin adverse events are: age 67: 568 reports, age 71: 546 reports, age 65: 538 reports, age 69: 531 reports, age 72: 519 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 Clarithromycin adverse event reports is Actavis Pharma, 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 Clarithromycin include: Malaise, Pyrexia, Off Label Use, Headache, Vomiting. 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 Clarithromycin 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.
Clarithromycin has a safety concern score of 85 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. Clarithromycin reports show a high percentage of serious adverse events, with dyspnoea and pneumonia among the most common.
Key safety signals identified in Clarithromycin's adverse event data include: High percentage of serious adverse events (92%). Common gastrointestinal issues like nausea and diarrhoea. Frequent drug interactions and ineffectiveness reports. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Clarithromycin can interact with various drugs, leading to potential adverse effects. It is important to inform healthcare providers of all medications being taken. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Clarithromycin.
Inform your healthcare provider of all medications and supplements you are taking to avoid potential drug interactions. Be aware of the common side effects and seek medical attention if they worsen or persist.
Clarithromycin has 66,659 adverse event reports on file with the FDA. The drug is frequently reported to cause gastrointestinal issues, including nausea and diarrhoea. The volume of reports for Clarithromycin reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors clarithromycin due to its high rate of serious adverse events. Patients should report any new symptoms to their healthcare provider immediately. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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