PEGINTERFERON ALFA 2A

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

About PEGINTERFERON ALFA 2A

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.

AI Safety Analysis

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.

Safety Score: 65/100

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.

Top Adverse Reactions

FATIGUE9,260 reports
NAUSEA7,160 reports
ANAEMIA6,620 reports
RASH4,876 reports
HEADACHE4,456 reports
WHITE BLOOD CELL COUNT DECREASED4,231 reports
PRURITUS4,222 reports
PYREXIA3,471 reports
DIARRHOEA3,386 reports
VOMITING3,334 reports
ASTHENIA3,151 reports
INSOMNIA3,078 reports
DYSPNOEA3,051 reports
DECREASED APPETITE2,917 reports
INFLUENZA LIKE ILLNESS2,735 reports
WEIGHT DECREASED2,658 reports
DIZZINESS2,625 reports
PLATELET COUNT DECREASED2,580 reports
DEPRESSION2,551 reports
PAIN2,543 reports
CHILLS2,191 reports
HAEMOGLOBIN DECREASED2,041 reports
ANORECTAL DISCOMFORT1,845 reports
DRUG INEFFECTIVE1,742 reports
ALOPECIA1,674 reports
DYSGEUSIA1,623 reports
MALAISE1,582 reports
ARTHRALGIA1,474 reports
RASH PRURITIC1,438 reports
RED BLOOD CELL COUNT DECREASED1,391 reports
ANXIETY1,287 reports
COUGH1,261 reports
IRRITABILITY1,252 reports
MYALGIA1,250 reports
DRY SKIN1,203 reports
NEUTROPENIA1,120 reports
THROMBOCYTOPENIA1,076 reports
HAEMORRHOIDS1,071 reports
OFF LABEL USE1,035 reports
BACK PAIN957 reports
RASH GENERALISED929 reports
ANAL PRURITUS896 reports
FEELING ABNORMAL891 reports
ABDOMINAL PAIN879 reports
DRUG DOSE OMISSION877 reports
DRY MOUTH838 reports
ABDOMINAL PAIN UPPER825 reports
VISION BLURRED825 reports
CHEST PAIN796 reports
NO ADVERSE EVENT764 reports
PNEUMONIA752 reports
DEHYDRATION740 reports
HEPATITIS C731 reports
CONSTIPATION728 reports
PAIN IN EXTREMITY726 reports
MEMORY IMPAIRMENT665 reports
EPISTAXIS664 reports
LEUKOPENIA664 reports
WEIGHT INCREASED637 reports
INJECTION SITE ERYTHEMA631 reports
PANCYTOPENIA626 reports
CONFUSIONAL STATE621 reports
MUSCLE SPASMS614 reports
NEUTROPHIL COUNT DECREASED608 reports
PRURITUS GENERALISED600 reports
HYPERHIDROSIS587 reports
STOMATITIS580 reports
DEATH578 reports
TREMOR570 reports
OROPHARYNGEAL PAIN521 reports
ABDOMINAL DISCOMFORT514 reports
RASH ERYTHEMATOUS508 reports
OEDEMA PERIPHERAL498 reports
HYPOAESTHESIA497 reports
MOOD SWINGS483 reports
ABDOMINAL DISTENSION477 reports
PROCTALGIA462 reports
DYSPEPSIA458 reports
SUICIDAL IDEATION447 reports
RASH PAPULAR427 reports
LOSS OF CONSCIOUSNESS425 reports
SOMNOLENCE422 reports
PARAESTHESIA413 reports
VISUAL IMPAIRMENT413 reports
ERYTHEMA407 reports
BLISTER404 reports
ANGER393 reports
DISTURBANCE IN ATTENTION387 reports
URTICARIA387 reports
FALL386 reports
INJECTION SITE REACTION385 reports
HEPATIC CIRRHOSIS382 reports
ASCITES381 reports
SYNCOPE381 reports
NASOPHARYNGITIS378 reports
VIRAL LOAD INCREASED377 reports
INJECTION SITE BRUISING376 reports
RECTAL HAEMORRHAGE375 reports
RENAL FAILURE370 reports
CONTUSION368 reports

Key Safety Signals

  • High frequency of serious adverse events (42.6%)
  • Multiple hematological issues including anemia, leukopenia, and thrombocytopenia
  • Significant number of neurological and psychiatric adverse events

Patient Demographics

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.

Report Outcomes

Out of 53,653 classified reports for PEGINTERFERON ALFA 2A:

  • Serious: 22,837 reports (42.6%) — includes hospitalization, disability, life-threatening events, or death
  • Non-Serious: 30,816 reports (57.4%)
Serious 42.6%Non-Serious 57.4%

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 Breakdown

Reports by Sex

Male27,337 (53.6%)
Female23,314 (45.7%)
Unknown398 (0.8%)

Reports by Age

Age 571,262 reports
Age 551,253 reports
Age 561,246 reports
Age 541,238 reports
Age 531,173 reports
Age 581,162 reports
Age 591,131 reports
Age 521,119 reports
Age 501,108 reports
Age 601,041 reports
Age 511,012 reports
Age 49988 reports
Age 48828 reports
Age 62825 reports
Age 61810 reports
Age 47716 reports
Age 63663 reports
Age 46609 reports
Age 64596 reports
Age 45532 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Drug Interactions & Warnings

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

What You Should Know

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.

Regulatory Context

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.

Frequently Asked Questions

How many adverse event reports has the FDA received for Peginterferon Alfa-2a?

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.

What are the most commonly reported side effects of Peginterferon Alfa-2a?

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.

What percentage of Peginterferon Alfa-2a adverse event reports are serious?

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.

Who reports adverse events for Peginterferon Alfa-2a (by sex)?

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.

What age groups report the most side effects for Peginterferon Alfa-2a?

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.

Who manufactures Peginterferon Alfa-2a?

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.

What other side effects have been reported for Peginterferon Alfa-2a?

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.

How do I report a side effect from Peginterferon Alfa-2a?

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.

What is Peginterferon Alfa-2a's safety score and what does it mean?

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.

What are the key safety signals for Peginterferon Alfa-2a?

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.

Does Peginterferon Alfa-2a interact with other drugs?

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.

What should patients know before taking 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.

Are Peginterferon Alfa-2a side effects well-documented?

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.

What is the FDA's position on Peginterferon Alfa-2a?

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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Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.