87/100 · Critical
Manufactured by Allergan, Inc.
High Safety Concerns with Dexamethasone Use
480,485 FDA adverse event reports analyzed
Last updated: 2026-05-12
DEXAMETHASONE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Allergan, Inc.. Based on analysis of 480,485 FDA adverse event reports, DEXAMETHASONE has a safety score of 87 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 DEXAMETHASONE include OFF LABEL USE, FATIGUE, DIARRHOEA, PLASMA CELL MYELOMA, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DEXAMETHASONE.
Dexamethasone has a safety concern score of 87 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 480,485 adverse event reports for this medication, which is primarily manufactured by Allergan, Inc..
The most commonly reported adverse events include Off Label Use, Fatigue, Diarrhoea. Of classified reports, 84.2% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Serious adverse events, including death and severe infections, are common.
Neutropenia and thrombocytopenia are frequent hematological side effects. Drug interactions and intolerances are reported, necessitating careful monitoring.
Patients taking Dexamethasone should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Dexamethasone can cause significant drug interactions and intolerances, requiring careful monitoring and dose adjustment. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Dexamethasone received a safety concern score of 87/100 (high concern). This is based on a 84.2% serious event ratio across 285,837 classified reports. The score accounts for 480,485 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: 129,648, Female: 122,367, Unknown: 1,724. The most frequently reported age groups are age 68 (5,829 reports), age 69 (5,787 reports), age 70 (5,785 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 285,837 classified reports for DEXAMETHASONE:
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.
Dexamethasone can cause significant drug interactions and intolerances, requiring careful monitoring and dose adjustment.
If you are taking Dexamethasone, here are important things to know. The most commonly reported side effects include off label use, fatigue, diarrhoea, plasma cell myeloma, nausea. 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 infections, particularly in elderly patients. Be aware of potential drug interactions and adjust dosing accordingly. 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 a focus on monitoring and managing serious adverse events and drug interactions.
The FDA has received approximately 480,485 adverse event reports associated with Dexamethasone. 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 Dexamethasone include Off Label Use, Fatigue, Diarrhoea, Plasma Cell Myeloma, Nausea. By volume, the top reported reactions are: Off Label Use (21,603 reports), Fatigue (16,525 reports), Diarrhoea (16,520 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Dexamethasone.
Out of 285,837 classified reports, 240,812 (84.2%) were classified as serious and 45,025 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 Dexamethasone break down by patient sex as follows: Male: 129,648, Female: 122,367, Unknown: 1,724. 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 Dexamethasone adverse events are: age 68: 5,829 reports, age 69: 5,787 reports, age 70: 5,785 reports, age 67: 5,764 reports, age 65: 5,725 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 Dexamethasone adverse event reports is Allergan, 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 Dexamethasone include: Pneumonia, Death, Drug Ineffective, Neutropenia, 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 Dexamethasone 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.
Dexamethasone has a safety concern score of 87 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 death and severe infections, are common.
Key safety signals identified in Dexamethasone's adverse event data include: High number of serious adverse events (84.2%). Frequent reports of death and pneumonia. Common hematological side effects like neutropenia and thrombocytopenia. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Dexamethasone can cause significant drug interactions and intolerances, requiring careful monitoring and dose adjustment. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Dexamethasone.
Monitor patients closely for signs of serious infections, particularly in elderly patients. Be aware of potential drug interactions and adjust dosing accordingly.
Dexamethasone has 480,485 adverse event reports on file with the FDA. Neutropenia and thrombocytopenia are frequent hematological side effects. The volume of reports for Dexamethasone reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with a focus on monitoring and managing serious adverse events and drug interactions. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
Explore other medications manufactured by Allergan, Inc. and compare their safety profiles:
The following drugs share commonly reported adverse reactions with DEXAMETHASONE:
Drugs related to DEXAMETHASONE based on therapeutic use, drug class, or shared indications: