35/100 · Moderate
Manufactured by Pharmacia & Upjohn Company LLC
Hydrocortisone Sodium Succinate Adverse Events: Common but Generally Non-Serious Reactions
54,773 FDA adverse event reports analyzed
Last updated: 2026-05-12
HYDROCORTISONE SODIUM SUCCINATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Pharmacia & Upjohn Company LLC. Based on analysis of 54,773 FDA adverse event reports, HYDROCORTISONE SODIUM SUCCINATE has a safety score of 35 out of 100. This lower score reflects a significant number of adverse event reports, suggesting that patients should discuss potential risks carefully with their healthcare provider. The most commonly reported adverse reactions for HYDROCORTISONE SODIUM SUCCINATE include OFF LABEL USE, INFUSION RELATED REACTION, PYREXIA, FATIGUE, DYSPNOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for HYDROCORTISONE SODIUM SUCCINATE.
Hydrocortisone Sodium Succinate has a safety concern score of 35 out of 100, placing it in the moderate concern category based on analysis of FDA adverse event data. The FDA has received approximately 54,773 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, Infusion Related Reaction, Pyrexia. Of classified reports, 91.0% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Most reported reactions are common and non-serious, such as fatigue, rash, and nausea.
The majority of reactions are related to infusion and systemic effects. There is a notable increase in serious reactions, particularly infections and respiratory issues. Drug interactions and warnings are primarily related to potential exacerbation of existing conditions. Regulatory context includes monitoring for serious adverse events and potential long-term effects.
Patients taking Hydrocortisone Sodium Succinate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Hydrocortisone Sodium Succinate can exacerbate existing conditions and may cause serious reactions, particularly in patients with pre-existing respiratory or infectious conditions. Close monitoring is advised during administration. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Hydrocortisone Sodium Succinate received a safety concern score of 35/100 (moderate concern). This is based on a 91.0% serious event ratio across 8,931 classified reports. The score accounts for 54,773 total adverse event reports and 100 distinct reaction types. This moderate score is typical for widely prescribed medications with established safety profiles.
Adverse event reports by sex: Female: 4,561, Male: 3,211, Unknown: 24. The most frequently reported age groups are age 44 (553 reports), age 43 (219 reports), age 63 (134 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 8,931 classified reports for HYDROCORTISONE 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.
Hydrocortisone Sodium Succinate can exacerbate existing conditions and may cause serious reactions, particularly in patients with pre-existing respiratory or infectious conditions. Close monitoring is advised during administration.
If you are taking Hydrocortisone Sodium Succinate, here are important things to know. The most commonly reported side effects include off label use, infusion related reaction, pyrexia, fatigue, dyspnoea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should inform their healthcare provider of any pre-existing conditions, especially respiratory or infectious diseases, before starting treatment with Hydrocortisone Sodium Succinate. Follow the prescribed dosage and administration instructions carefully to minimize the risk of adverse reactions. 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 profile of Hydrocortisone Sodium Succinate, particularly for serious adverse events. Healthcare providers should report any serious reactions to the FDA's MedWatch program.
The FDA has received approximately 54,773 adverse event reports associated with Hydrocortisone 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 Hydrocortisone Sodium Succinate include Off Label Use, Infusion Related Reaction, Pyrexia, Fatigue, Dyspnoea. By volume, the top reported reactions are: Off Label Use (1,556 reports), Infusion Related Reaction (1,180 reports), Pyrexia (1,045 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Hydrocortisone Sodium Succinate.
Out of 8,931 classified reports, 8,129 (91.0%) were classified as serious and 802 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 Hydrocortisone Sodium Succinate break down by patient sex as follows: Female: 4,561, Male: 3,211, Unknown: 24. 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 Hydrocortisone Sodium Succinate adverse events are: age 44: 553 reports, age 43: 219 reports, age 63: 134 reports, age 40: 126 reports, age 70: 116 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 Hydrocortisone 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 Hydrocortisone Sodium Succinate include: Nausea, Pain, Rash, Diarrhoea, Headache. 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 Hydrocortisone 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.
Hydrocortisone Sodium Succinate has a safety concern score of 35 out of 100 (moderate 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. Most reported reactions are common and non-serious, such as fatigue, rash, and nausea.
Key safety signals identified in Hydrocortisone Sodium Succinate's adverse event data include: Infusion-related reactions are frequent, indicating potential issues with administration.. Respiratory issues like dyspnea and pneumonia are significant, warranting close monitoring.. Infections, particularly pneumonia, are a key safety signal, especially in older adults.. There is a notable increase in serious reactions, suggesting a need for careful patient selection.. Drug ineffectiveness and hyper-sensitivity reactions indicate variability in patient response.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Hydrocortisone Sodium Succinate can exacerbate existing conditions and may cause serious reactions, particularly in patients with pre-existing respiratory or infectious conditions. Close monitoring is advised during administration. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Hydrocortisone Sodium Succinate.
Patients should inform their healthcare provider of any pre-existing conditions, especially respiratory or infectious diseases, before starting treatment with Hydrocortisone Sodium Succinate. Follow the prescribed dosage and administration instructions carefully to minimize the risk of adverse reactions.
Hydrocortisone Sodium Succinate has 54,773 adverse event reports on file with the FDA. The majority of reactions are related to infusion and systemic effects. The volume of reports for Hydrocortisone Sodium Succinate reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety profile of Hydrocortisone Sodium Succinate, particularly for serious adverse events. Healthcare providers should report any serious reactions to the FDA's MedWatch program. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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