85/100 · Critical
Manufactured by Baxter Healthcare Company
Serious Adverse Reactions Common with Ceftriaxone Sodium
62,910 FDA adverse event reports analyzed
Last updated: 2026-05-12
CEFTRIAXONE SODIUM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Baxter Healthcare Company. Based on analysis of 62,910 FDA adverse event reports, CEFTRIAXONE SODIUM 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 SODIUM include OFF LABEL USE, DRUG INEFFECTIVE, PYREXIA, ACUTE KIDNEY INJURY, DYSPNOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CEFTRIAXONE SODIUM.
Ceftriaxone Sodium 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 62,910 adverse event reports for this medication, which is primarily manufactured by Baxter Healthcare Company.
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 reactions, including acute kidney injury and sepsis, are frequently reported.
Drug interactions and ineffective drug performance are notable concerns. Multiple organ dysfunction syndrome and respiratory failure are significant safety signals. Fatal outcomes are reported, with a serious reaction rate of 94.2%.
Patients taking Ceftriaxone Sodium should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Ceftriaxone sodium can interact with other drugs, potentially leading to adverse effects. Warnings include drug interactions and ineffectiveness for unapproved indications. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Ceftriaxone Sodium received a safety concern score of 85/100 (high concern). This is based on a 94.2% serious event ratio across 36,589 classified reports. The score accounts for 62,910 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: 17,635, Female: 15,484, Unknown: 101. The most frequently reported age groups are age 80 (734 reports), age 60 (693 reports), age 61 (639 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 36,589 classified reports for CEFTRIAXONE SODIUM:
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 sodium can interact with other drugs, potentially leading to adverse effects. Warnings include drug interactions and ineffectiveness for unapproved indications.
If you are taking Ceftriaxone Sodium, here are important things to know. The most commonly reported side effects include off label use, drug ineffective, pyrexia, acute kidney injury, dyspnoea. 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 serious adverse reactions, especially kidney injury and sepsis. Be aware of potential drug interactions and ensure proper dosing. 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 the FDA monitoring adverse events and updating safety information as needed.
The FDA has received approximately 62,910 adverse event reports associated with Ceftriaxone Sodium. 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 Sodium include Off Label Use, Drug Ineffective, Pyrexia, Acute Kidney Injury, Dyspnoea. By volume, the top reported reactions are: Off Label Use (3,725 reports), Drug Ineffective (3,336 reports), Pyrexia (1,966 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 Sodium.
Out of 36,589 classified reports, 34,457 (94.2%) were classified as serious and 2,132 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 Sodium break down by patient sex as follows: Male: 17,635, Female: 15,484, Unknown: 101. 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 Sodium adverse events are: age 80: 734 reports, age 60: 693 reports, age 61: 639 reports, age 69: 614 reports, age 70: 611 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 Sodium adverse event reports is Baxter Healthcare Company. 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 Sodium include: Condition Aggravated, Pneumonia, Vomiting, Nausea, Drug Interaction. 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 Sodium 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 Sodium 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 reactions, including acute kidney injury and sepsis, are frequently reported.
Key safety signals identified in Ceftriaxone Sodium's adverse event data include: Acute kidney injury and sepsis are the most common serious reactions.. Drug ineffectiveness and drug interactions are frequent.. Multiple organ dysfunction syndrome and respiratory failure are key safety signals.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Ceftriaxone sodium can interact with other drugs, potentially leading to adverse effects. Warnings include drug interactions and ineffectiveness for unapproved indications. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Ceftriaxone Sodium.
Monitor patients closely for signs of serious adverse reactions, especially kidney injury and sepsis. Be aware of potential drug interactions and ensure proper dosing.
Ceftriaxone Sodium has 62,910 adverse event reports on file with the FDA. Drug interactions and ineffective drug performance are notable concerns. The volume of reports for Ceftriaxone Sodium reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with the FDA monitoring adverse events and updating safety information as needed. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
Explore other medications manufactured by Baxter Healthcare Company and compare their safety profiles:
The following drugs share commonly reported adverse reactions with CEFTRIAXONE SODIUM:
Drugs related to CEFTRIAXONE SODIUM based on therapeutic use, drug class, or shared indications: