85/100 · Critical
Manufactured by Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.
High Seriousness in Prednisolone Oral Solution Adverse Events
280,064 FDA adverse event reports analyzed
Last updated: 2026-05-12
PREDNISOLONE ORAL SOLUTION is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.. Based on analysis of 280,064 FDA adverse event reports, PREDNISOLONE ORAL SOLUTION 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 PREDNISOLONE ORAL SOLUTION include OFF LABEL USE, DRUG INEFFECTIVE, PYREXIA, DYSPNOEA, PNEUMONIA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for PREDNISOLONE ORAL SOLUTION.
Prednisolone Oral Solution 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 280,064 adverse event reports for this medication, which is primarily manufactured by Heritage Pharma Labs Inc. D/B/A Avet Pharmaceuticals Labs Inc..
The most commonly reported adverse events include Off Label Use, Drug Ineffective, Pyrexia. Of classified reports, 95.6% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The majority of adverse events are serious, with over 95% of reports being serious.
A wide range of reactions are reported, indicating diverse safety concerns. Report volume is substantial, with over 280,000 total reports.
Patients taking Prednisolone Oral Solution should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Prednisolone can interact with other drugs, potentially leading to adverse effects. Warnings include monitoring for drug interactions and managing concomitant medications. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Prednisolone Oral Solution received a safety concern score of 85/100 (high concern). This is based on a 95.6% serious event ratio across 173,231 classified reports. The score accounts for 280,064 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: 82,147, Male: 71,844, Unknown: 768. The most frequently reported age groups are age 70 (2,824 reports), age 66 (2,790 reports), age 65 (2,787 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 173,231 classified reports for PREDNISOLONE ORAL SOLUTION:
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.
Prednisolone can interact with other drugs, potentially leading to adverse effects. Warnings include monitoring for drug interactions and managing concomitant medications.
If you are taking Prednisolone Oral Solution, here are important things to know. The most commonly reported side effects include off label use, drug ineffective, pyrexia, dyspnoea, pneumonia. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Follow prescribed dosages and duration of use strictly to minimize risks. Report any unusual symptoms to healthcare providers promptly. 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 closely monitors these reports and may require additional safety studies or label changes based on ongoing data.
The FDA has received approximately 280,064 adverse event reports associated with Prednisolone Oral Solution. 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 Prednisolone Oral Solution include Off Label Use, Drug Ineffective, Pyrexia, Dyspnoea, Pneumonia. By volume, the top reported reactions are: Off Label Use (14,441 reports), Drug Ineffective (12,315 reports), Pyrexia (8,193 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Prednisolone Oral Solution.
Out of 173,231 classified reports, 165,525 (95.6%) were classified as serious and 7,706 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 Prednisolone Oral Solution break down by patient sex as follows: Female: 82,147, Male: 71,844, Unknown: 768. 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 Prednisolone Oral Solution adverse events are: age 70: 2,824 reports, age 66: 2,790 reports, age 65: 2,787 reports, age 67: 2,729 reports, age 69: 2,700 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 Prednisolone Oral Solution adverse event reports is Heritage Pharma Labs Inc. D/B/A Avet Pharmaceuticals Labs 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 Prednisolone Oral Solution include: Diarrhoea, Condition Aggravated, Nausea, Vomiting, Product Use In Unapproved Indication. 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 Prednisolone Oral Solution 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.
Prednisolone Oral Solution 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. The majority of adverse events are serious, with over 95% of reports being serious.
Key safety signals identified in Prednisolone Oral Solution's adverse event data include: Severe infections (Pneumonia, Sepsis, Fungal Infections) are frequently reported.. Significant cardiovascular issues (Hypertension, Cardiac Failure) are noted.. Neurological and psychiatric issues (Confusion, Anxiety, Depression) are common.. Renal and hepatic dysfunction (Acute Kidney Injury, Hepatic Function Abnormal) are also frequent.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Prednisolone can interact with other drugs, potentially leading to adverse effects. Warnings include monitoring for drug interactions and managing concomitant medications. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Prednisolone Oral Solution.
Follow prescribed dosages and duration of use strictly to minimize risks. Report any unusual symptoms to healthcare providers promptly.
Prednisolone Oral Solution has 280,064 adverse event reports on file with the FDA. A wide range of reactions are reported, indicating diverse safety concerns. The volume of reports for Prednisolone Oral Solution reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors these reports 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.
The following drugs share commonly reported adverse reactions with PREDNISOLONE ORAL SOLUTION:
Drugs related to PREDNISOLONE ORAL SOLUTION based on therapeutic use, drug class, or shared indications: