85/100 · Critical
Manufactured by Hp Halden Pharma AS
Linezolid Adverse Events: High Seriousness and Diverse Reactions
47,534 FDA adverse event reports analyzed
Last updated: 2026-05-12
LINEZOLID is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Hp Halden Pharma AS. Based on analysis of 47,534 FDA adverse event reports, LINEZOLID 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 LINEZOLID include OFF LABEL USE, THROMBOCYTOPENIA, DRUG INEFFECTIVE, ANAEMIA, DRUG INTERACTION. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for LINEZOLID.
Linezolid 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 47,534 adverse event reports for this medication, which is primarily manufactured by Hp Halden Pharma As.
The most commonly reported adverse events include Off Label Use, Thrombocytopenia, Drug Ineffective. Of classified reports, 90.6% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Linezolid reports show a high percentage of serious adverse events, with over 90% of reported outcomes being serious.
The drug is associated with a wide range of reactions, including neurological, hematological, and gastrointestinal issues. Death and severe infections are among the most reported serious adverse events.
Patients taking Linezolid should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Linezolid can interact with other drugs, leading to potential toxicity. Warnings include interactions with drugs that affect QT interval and those that can cause bone marrow suppression. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Linezolid received a safety concern score of 85/100 (high concern). This is based on a 90.6% serious event ratio across 27,999 classified reports. The score accounts for 47,534 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: 13,828, Female: 10,735, Unknown: 180. The most frequently reported age groups are age 65 (496 reports), age 70 (495 reports), age 67 (455 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 27,999 classified reports for LINEZOLID:
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.
Linezolid can interact with other drugs, leading to potential toxicity. Warnings include interactions with drugs that affect QT interval and those that can cause bone marrow suppression.
If you are taking Linezolid, here are important things to know. The most commonly reported side effects include off label use, thrombocytopenia, drug ineffective, anaemia, drug interaction. 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 new or worsening symptoms to their healthcare provider immediately. Follow all prescribed dosages and do not alter the treatment without medical advice. 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 Linezolid for safety, particularly for serious adverse events and drug interactions. Healthcare providers should be vigilant and report any adverse events.
The FDA has received approximately 47,534 adverse event reports associated with Linezolid. 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 Linezolid include Off Label Use, Thrombocytopenia, Drug Ineffective, Anaemia, Drug Interaction. By volume, the top reported reactions are: Off Label Use (2,426 reports), Thrombocytopenia (2,032 reports), Drug Ineffective (1,993 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Linezolid.
Out of 27,999 classified reports, 25,361 (90.6%) were classified as serious and 2,638 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 Linezolid break down by patient sex as follows: Male: 13,828, Female: 10,735, Unknown: 180. 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 Linezolid adverse events are: age 65: 496 reports, age 70: 495 reports, age 67: 455 reports, age 60: 441 reports, age 66: 437 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 Linezolid adverse event reports is Hp Halden Pharma As. 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 Linezolid include: Nausea, Vomiting, Diarrhoea, Platelet Count Decreased, Pyrexia. 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 Linezolid 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.
Linezolid 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. Linezolid reports show a high percentage of serious adverse events, with over 90% of reported outcomes being serious.
Key safety signals identified in Linezolid's adverse event data include: Serious adverse events (25,361 out of 27,999) make up over 90% of the total reported outcomes.. Neurological issues such as peripheral neuropathy and serotonin syndrome are key safety signals.. Hematological issues like pancytopenia and thrombocytopenia are also significant safety signals.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Linezolid can interact with other drugs, leading to potential toxicity. Warnings include interactions with drugs that affect QT interval and those that can cause bone marrow suppression. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Linezolid.
Patients should report any new or worsening symptoms to their healthcare provider immediately. Follow all prescribed dosages and do not alter the treatment without medical advice.
Linezolid has 47,534 adverse event reports on file with the FDA. The drug is associated with a wide range of reactions, including neurological, hematological, and gastrointestinal issues. The volume of reports for Linezolid reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor Linezolid for safety, particularly for serious adverse events and drug interactions. Healthcare providers should be vigilant and report any adverse events. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
The following drugs share commonly reported adverse reactions with LINEZOLID:
Drugs related to LINEZOLID based on therapeutic use, drug class, or shared indications: