85/100 · Critical
Manufactured by Pharmacia & Upjohn Company LLC
High Serious Adverse Events for Methylprednisolone Sodium Succinate
177,552 FDA adverse event reports analyzed
Last updated: 2026-05-12
METHYLPREDNISOLONE SODIUM SUCCINATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Pharmacia & Upjohn Company LLC. Based on analysis of 177,552 FDA adverse event reports, METHYLPREDNISOLONE SODIUM SUCCINATE 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 METHYLPREDNISOLONE SODIUM SUCCINATE include OFF LABEL USE, DRUG INEFFECTIVE, FATIGUE, HEADACHE, PAIN. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for METHYLPREDNISOLONE SODIUM SUCCINATE.
Methylprednisolone Sodium Succinate 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 177,552 adverse event reports for this medication, which is primarily manufactured by Pharmacia & Upjohn Company Llc.
The most commonly reported adverse events include Off Label Use, Drug Ineffective, Fatigue. Of classified reports, 89.3% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. A high percentage of serious adverse events (89.3%) were reported, indicating significant safety concerns.
The most common reactions include fatigue, headache, and infusion-related reactions, suggesting these as potential side effects. There is a notable increase in serious respiratory issues like pneumonia and dyspnoea, warranting close monitoring.
Patients taking Methylprednisolone Sodium Succinate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Methylprednisolone Sodium Succinate can cause serious respiratory issues and should be used with caution, especially in patients with pre-existing respiratory conditions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Methylprednisolone Sodium Succinate received a safety concern score of 85/100 (high concern). This is based on a 89.3% serious event ratio across 44,541 classified reports. The score accounts for 177,552 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: Female: 23,123, Male: 15,289, Unknown: 124. The most frequently reported age groups are age 40 (966 reports), age 43 (928 reports), age 65 (795 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 44,541 classified reports for METHYLPREDNISOLONE SODIUM SUCCINATE:
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.
Methylprednisolone Sodium Succinate can cause serious respiratory issues and should be used with caution, especially in patients with pre-existing respiratory conditions.
If you are taking Methylprednisolone Sodium Succinate, here are important things to know. The most commonly reported side effects include off label use, drug ineffective, fatigue, headache, pain. 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 serious adverse events to their healthcare provider immediately. Follow the prescribed dosage and use as directed to minimize the risk of side effects. 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 the safety of Methylprednisolone Sodium Succinate and may require additional safety studies or label changes based on ongoing data.
The FDA has received approximately 177,552 adverse event reports associated with Methylprednisolone Sodium Succinate. 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 Methylprednisolone Sodium Succinate include Off Label Use, Drug Ineffective, Fatigue, Headache, Pain. By volume, the top reported reactions are: Off Label Use (7,612 reports), Drug Ineffective (4,156 reports), Fatigue (4,126 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Methylprednisolone Sodium Succinate.
Out of 44,541 classified reports, 39,760 (89.3%) were classified as serious and 4,781 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 Methylprednisolone Sodium Succinate break down by patient sex as follows: Female: 23,123, Male: 15,289, Unknown: 124. 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 Methylprednisolone Sodium Succinate adverse events are: age 40: 966 reports, age 43: 928 reports, age 65: 795 reports, age 59: 754 reports, age 58: 738 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 Methylprednisolone Sodium Succinate adverse event reports is Pharmacia & Upjohn Company Llc. 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 Methylprednisolone Sodium Succinate include: Infusion Related Reaction, Nausea, Pyrexia, Dyspnoea, Rash. 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 Methylprednisolone Sodium Succinate 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.
Methylprednisolone Sodium Succinate 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. A high percentage of serious adverse events (89.3%) were reported, indicating significant safety concerns.
Key safety signals identified in Methylprednisolone Sodium Succinate's adverse event data include: High percentage of serious adverse events (89.3%). Common reactions include fatigue, headache, and infusion-related reactions. Increased reports of serious respiratory issues like pneumonia and dyspnoea. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Methylprednisolone Sodium Succinate can cause serious respiratory issues and should be used with caution, especially in patients with pre-existing respiratory conditions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Methylprednisolone Sodium Succinate.
Patients should report any serious adverse events to their healthcare provider immediately. Follow the prescribed dosage and use as directed to minimize the risk of side effects.
Methylprednisolone Sodium Succinate has 177,552 adverse event reports on file with the FDA. The most common reactions include fatigue, headache, and infusion-related reactions, suggesting these as potential side effects. The volume of reports for Methylprednisolone Sodium Succinate reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of Methylprednisolone Sodium Succinate and may require additional safety studies or label changes based on ongoing data. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
Explore other medications manufactured by Pharmacia & Upjohn Company LLC and compare their safety profiles:
The following drugs share commonly reported adverse reactions with METHYLPREDNISOLONE SODIUM SUCCINATE:
Drugs related to METHYLPREDNISOLONE SODIUM SUCCINATE based on therapeutic use, drug class, or shared indications: