65/100 · Elevated
Manufactured by pharmaand GmbH
Moderate Safety Concerns with Peginterferon Alfa-2A
141,362 FDA adverse event reports analyzed
Last updated: 2026-05-12
PEGINTERFERON ALFA 2A is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by pharmaand GmbH. Based on analysis of 141,362 FDA adverse event reports, PEGINTERFERON ALFA 2A has a safety score of 65 out of 100. This moderate score indicates a notable volume of adverse event reports that patients and providers should be aware of. The most commonly reported adverse reactions for PEGINTERFERON ALFA 2A include FATIGUE, NAUSEA, ANAEMIA, RASH, HEADACHE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for PEGINTERFERON ALFA 2A.
Peginterferon Alfa-2a has a safety concern score of 65 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 141,362 adverse event reports for this medication, which is primarily manufactured by Pharmaand Gmbh.
The most commonly reported adverse events include Fatigue, Nausea, Anaemia. Of classified reports, 42.6% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Fatigue, nausea, and anemia are the most commonly reported adverse events.
A significant number of serious adverse events, including death and hepatitis C, are reported. The drug is associated with a wide range of adverse reactions, indicating potential for diverse side effects. Reports indicate a notable decrease in white blood cell and platelet counts.
Patients taking Peginterferon Alfa-2a should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Peginterferon Alfa-2A can cause significant hematological and neurological side effects, and patients should be monitored closely for these conditions. Drug interactions are not specifically warned against, but caution is advised due to the drug's im This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Peginterferon Alfa-2a received a safety concern score of 65/100 (elevated concern). This is based on a 42.6% serious event ratio across 53,653 classified reports. The score accounts for 141,362 total adverse event reports and 100 distinct reaction types. This elevated score indicates a notable proportion of serious adverse events and warrants careful monitoring.
Adverse event reports by sex: Male: 27,337, Female: 23,314, Unknown: 398. The most frequently reported age groups are age 57 (1,262 reports), age 55 (1,253 reports), age 56 (1,246 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 53,653 classified reports for PEGINTERFERON ALFA 2A:
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.
Peginterferon Alfa-2A can cause significant hematological and neurological side effects, and patients should be monitored closely for these conditions. Drug interactions are not specifically warned against, but caution is advised due to the drug's im
If you are taking Peginterferon Alfa-2a, here are important things to know. The most commonly reported side effects include fatigue, nausea, anaemia, rash, headache. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor for signs of severe fatigue, nausea, and anemia, and report these to your healthcare provider. Regularly check your blood cell counts, especially if you experience unusual symptoms. 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 adverse events for Peginterferon Alfa-2A. Patients should report any new or worsening symptoms to their healthcare provider promptly. Regular blood tests are recommended to monitor for hematological changes.
The FDA has received approximately 141,362 adverse event reports associated with Peginterferon Alfa-2a. 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 Peginterferon Alfa-2a include Fatigue, Nausea, Anaemia, Rash, Headache. By volume, the top reported reactions are: Fatigue (9,260 reports), Nausea (7,160 reports), Anaemia (6,620 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Peginterferon Alfa-2a.
Out of 53,653 classified reports, 22,837 (42.6%) were classified as serious and 30,816 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 Peginterferon Alfa-2a break down by patient sex as follows: Male: 27,337, Female: 23,314, Unknown: 398. 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 Peginterferon Alfa-2a adverse events are: age 57: 1,262 reports, age 55: 1,253 reports, age 56: 1,246 reports, age 54: 1,238 reports, age 53: 1,173 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 Peginterferon Alfa-2a adverse event reports is Pharmaand Gmbh. 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 Peginterferon Alfa-2a include: White Blood Cell Count Decreased, Pruritus, Pyrexia, Diarrhoea, Vomiting. 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 Peginterferon Alfa-2a 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.
Peginterferon Alfa-2a has a safety concern score of 65 out of 100 (elevated 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. Fatigue, nausea, and anemia are the most commonly reported adverse events.
Key safety signals identified in Peginterferon Alfa-2a's adverse event data include: High frequency of serious adverse events (42.6%). Multiple hematological issues including anemia, leukopenia, and thrombocytopenia. Significant number of neurological and psychiatric adverse events. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Peginterferon Alfa-2A can cause significant hematological and neurological side effects, and patients should be monitored closely for these conditions. Drug interactions are not specifically warned against, but caution is advised due to the drug's im Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Peginterferon Alfa-2a.
Monitor for signs of severe fatigue, nausea, and anemia, and report these to your healthcare provider. Regularly check your blood cell counts, especially if you experience unusual symptoms.
Peginterferon Alfa-2a has 141,362 adverse event reports on file with the FDA. A significant number of serious adverse events, including death and hepatitis C, are reported. The volume of reports for Peginterferon Alfa-2a reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors adverse events for Peginterferon Alfa-2A. Patients should report any new or worsening symptoms to their healthcare provider promptly. Regular blood tests are recommended to monitor for hematological changes. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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