85/100 · Critical
Manufactured by ARMAS PHARMACEUTICALS INC
Meropenem Adverse Events Show High Seriousness and Diverse Reactions
56,187 FDA adverse event reports analyzed
Last updated: 2026-05-12
MEROPENEM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by ARMAS PHARMACEUTICALS INC. Based on analysis of 56,187 FDA adverse event reports, MEROPENEM 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 MEROPENEM include DRUG INEFFECTIVE, OFF LABEL USE, PYREXIA, PNEUMONIA, SEPSIS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for MEROPENEM.
Meropenem 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 56,187 adverse event reports for this medication, which is primarily manufactured by Armas Pharmaceuticals Inc.
The most commonly reported adverse events include Drug Ineffective, Off Label Use, Pyrexia. Of classified reports, 97.1% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. High percentage of serious adverse events (97.1%) indicates significant safety concerns.
A wide range of reactions, including severe infections and organ dysfunctions, are reported. Neutropenia and renal impairment are among the most frequently reported conditions.
Patients taking Meropenem should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Meropenem can cause drug interactions, and its use should be monitored for potential interactions with other antibiotics and antifungals. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Meropenem received a safety concern score of 85/100 (high concern). This is based on a 97.1% serious event ratio across 30,401 classified reports. The score accounts for 56,187 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: 15,763, Female: 12,084, Unknown: 102. The most frequently reported age groups are age 66 (580 reports), age 64 (568 reports), age 67 (565 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 30,401 classified reports for MEROPENEM:
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.
Meropenem can cause drug interactions, and its use should be monitored for potential interactions with other antibiotics and antifungals.
If you are taking Meropenem, here are important things to know. The most commonly reported side effects include drug ineffective, off label use, pyrexia, pneumonia, sepsis. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should report any adverse reactions to healthcare providers immediately. Follow healthcare provider's instructions carefully, especially regarding dosage and duration of treatment. 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 Meropenem being subject to safety monitoring and potential updates to labeling.
The FDA has received approximately 56,187 adverse event reports associated with Meropenem. 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 Meropenem include Drug Ineffective, Off Label Use, Pyrexia, Pneumonia, Sepsis. By volume, the top reported reactions are: Drug Ineffective (4,221 reports), Off Label Use (3,118 reports), Pyrexia (2,090 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Meropenem.
Out of 30,401 classified reports, 29,516 (97.1%) were classified as serious and 885 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 Meropenem break down by patient sex as follows: Male: 15,763, Female: 12,084, Unknown: 102. 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 Meropenem adverse events are: age 66: 580 reports, age 64: 568 reports, age 67: 565 reports, age 65: 561 reports, age 63: 548 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 Meropenem adverse event reports is Armas Pharmaceuticals 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 Meropenem include: Septic Shock, Multiple Organ Dysfunction Syndrome, Acute Kidney Injury, Condition Aggravated, Respiratory Failure. 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 Meropenem 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.
Meropenem 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. High percentage of serious adverse events (97.1%) indicates significant safety concerns.
Key safety signals identified in Meropenem's adverse event data include: Severe infections like sepsis and pneumonia are common.. Organ dysfunctions such as acute kidney injury and multi-organ failure are frequently reported.. Neutropenia and thrombocytopenia are significant safety signals.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Meropenem can cause drug interactions, and its use should be monitored for potential interactions with other antibiotics and antifungals. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Meropenem.
Patients should report any adverse reactions to healthcare providers immediately. Follow healthcare provider's instructions carefully, especially regarding dosage and duration of treatment.
Meropenem has 56,187 adverse event reports on file with the FDA. A wide range of reactions, including severe infections and organ dysfunctions, are reported. The volume of reports for Meropenem reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with Meropenem being subject to safety monitoring and potential updates to labeling. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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