85/100 · Critical
Manufactured by Granulation Technology, Inc.
Prednisone Adverse Events: High Seriousness and Diverse Reactions
1,354,057 FDA adverse event reports analyzed
Last updated: 2026-05-12
PREDNISONE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Granulation Technology, Inc.. Based on analysis of 1,354,057 FDA adverse event reports, PREDNISONE 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 PREDNISONE include DRUG INEFFECTIVE, OFF LABEL USE, FATIGUE, PAIN, DYSPNOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for PREDNISONE.
Prednisone 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 1,354,057 adverse event reports for this medication, which is primarily manufactured by Granulation Technology, Inc..
The most commonly reported adverse events include Drug Ineffective, Off Label Use, Fatigue. Of classified reports, 78.5% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Prednisone reports show a high percentage of serious adverse events (78.5%).
The most common reactions include fatigue, pain, and dyspnea, indicating a broad range of potential side effects. Death and pneumonia are among the top serious reactions, highlighting significant risks.
Patients taking Prednisone should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Prednisone can interact with other drugs, potentially leading to adverse effects. Warnings include drug intolerance, hyper-sensitivity, and contraindications. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Prednisone received a safety concern score of 85/100 (high concern). This is based on a 78.5% serious event ratio across 482,716 classified reports. The score accounts for 1,354,057 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: 257,446, Male: 169,770, Unknown: 2,032. The most frequently reported age groups are age 65 (8,661 reports), age 60 (8,169 reports), age 64 (7,808 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 482,716 classified reports for PREDNISONE:
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.
Prednisone can interact with other drugs, potentially leading to adverse effects. Warnings include drug intolerance, hyper-sensitivity, and contraindications.
If you are taking Prednisone, here are important things to know. The most commonly reported side effects include drug ineffective, off label use, fatigue, pain, dyspnoea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Consult healthcare providers before starting or stopping prednisone, especially for long-term use. Report any unusual symptoms or side effects to your healthcare provider immediately. 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 prednisone safety, with ongoing reviews to ensure patient safety and efficacy.
The FDA has received approximately 1,354,057 adverse event reports associated with Prednisone. 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 Prednisone include Drug Ineffective, Off Label Use, Fatigue, Pain, Dyspnoea. By volume, the top reported reactions are: Drug Ineffective (64,638 reports), Off Label Use (53,163 reports), Fatigue (39,613 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Prednisone.
Out of 482,716 classified reports, 379,096 (78.5%) were classified as serious and 103,620 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 Prednisone break down by patient sex as follows: Female: 257,446, Male: 169,770, Unknown: 2,032. 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 Prednisone adverse events are: age 65: 8,661 reports, age 60: 8,169 reports, age 64: 7,808 reports, age 62: 7,663 reports, age 61: 7,643 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 Prednisone adverse event reports is Granulation Technology, 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 Prednisone include: Arthralgia, Condition Aggravated, Nausea, 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 Prednisone 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.
Prednisone 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. Prednisone reports show a high percentage of serious adverse events (78.5%).
Key safety signals identified in Prednisone's adverse event data include: High percentage of serious reactions (379,096 out of 482,716, 78.5%). Diverse reactions including respiratory issues, infections, and musculoskeletal problems. Significant number of reports related to death and pneumonia. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Prednisone can interact with other drugs, potentially leading to adverse effects. Warnings include drug intolerance, hyper-sensitivity, and contraindications. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Prednisone.
Consult healthcare providers before starting or stopping prednisone, especially for long-term use. Report any unusual symptoms or side effects to your healthcare provider immediately.
Prednisone has 1,354,057 adverse event reports on file with the FDA. The most common reactions include fatigue, pain, and dyspnea, indicating a broad range of potential side effects. The volume of reports for Prednisone reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor prednisone safety, with ongoing reviews to ensure patient safety and efficacy. 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 PREDNISONE:
Drugs related to PREDNISONE based on therapeutic use, drug class, or shared indications: