85/100 · Critical
Manufactured by B. Braun Medical Inc.
High Safety Concerns with Ceftriaxone, Particularly for Older Adults
52,413 FDA adverse event reports analyzed
Last updated: 2026-05-12
CEFTRIAXONE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by B. Braun Medical Inc.. Based on analysis of 52,413 FDA adverse event reports, CEFTRIAXONE 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 CEFTRIAXONE include OFF LABEL USE, DRUG INEFFECTIVE, PYREXIA, ACUTE KIDNEY INJURY, CONDITION AGGRAVATED. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CEFTRIAXONE.
Ceftriaxone 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 52,413 adverse event reports for this medication, which is primarily manufactured by B. Braun Medical Inc..
The most commonly reported adverse events include Off Label Use, Drug Ineffective, Pyrexia. Of classified reports, 94.2% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Serious adverse events, including kidney injury and sepsis, are common.
The majority of reports are serious, with a high percentage of adverse reactions. Drug interactions and ineffective treatment are also significant concerns.
Patients taking Ceftriaxone should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Ceftriaxone can interact with other antibiotics and may cause drug ineffectiveness or severe allergic reactions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Ceftriaxone received a safety concern score of 85/100 (high concern). This is based on a 94.2% serious event ratio across 31,338 classified reports. The score accounts for 52,413 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: Male: 15,134, Female: 13,148, Unknown: 89. The most frequently reported age groups are age 67 (543 reports), age 69 (534 reports), age 72 (512 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 31,338 classified reports for CEFTRIAXONE:
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.
Ceftriaxone can interact with other antibiotics and may cause drug ineffectiveness or severe allergic reactions.
If you are taking Ceftriaxone, here are important things to know. The most commonly reported side effects include off label use, drug ineffective, pyrexia, acute kidney injury, condition aggravated. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor patients closely for signs of kidney injury, sepsis, and allergic reactions. Ensure proper dosing and avoid off-label use to reduce the risk of adverse events. 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 frequent updates on safety concerns and warnings.
The FDA has received approximately 52,413 adverse event reports associated with Ceftriaxone. 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 Ceftriaxone include Off Label Use, Drug Ineffective, Pyrexia, Acute Kidney Injury, Condition Aggravated. By volume, the top reported reactions are: Off Label Use (3,403 reports), Drug Ineffective (3,010 reports), Pyrexia (1,678 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Ceftriaxone.
Out of 31,338 classified reports, 29,519 (94.2%) were classified as serious and 1,819 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 Ceftriaxone break down by patient sex as follows: Male: 15,134, Female: 13,148, Unknown: 89. 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 Ceftriaxone adverse events are: age 67: 543 reports, age 69: 534 reports, age 72: 512 reports, age 74: 510 reports, age 61: 507 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 Ceftriaxone adverse event reports is B. Braun Medical 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 Ceftriaxone include: Dyspnoea, Pneumonia, Drug Interaction, Vomiting, Nausea. 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 Ceftriaxone 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.
Ceftriaxone 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. Serious adverse events, including kidney injury and sepsis, are common.
Key safety signals identified in Ceftriaxone's adverse event data include: Acute kidney injury and sepsis are key safety signals.. Drug ineffectiveness and drug interactions are frequent.. Severe allergic reactions and fatalities are reported.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Ceftriaxone can interact with other antibiotics and may cause drug ineffectiveness or severe allergic reactions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Ceftriaxone.
Monitor patients closely for signs of kidney injury, sepsis, and allergic reactions. Ensure proper dosing and avoid off-label use to reduce the risk of adverse events.
Ceftriaxone has 52,413 adverse event reports on file with the FDA. The majority of reports are serious, with a high percentage of adverse reactions. The volume of reports for Ceftriaxone reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with frequent updates on safety concerns and warnings. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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