PEGINTERFERON ALFA-2B: 4,226 Adverse Event Reports & Safety Profile
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4,226
Total FAERS Reports
184 (4.4%)
Deaths Reported
978
Hospitalizations
4,226
As Primary/Secondary Suspect
129
Life-Threatening
99
Disabilities
Prescription
Status
FDA Application: 103949 ·
First Report: 1994 · Latest Report: 20250805
What Are the Most Common PEGINTERFERON ALFA-2B Side Effects?
#1 Most Reported
Anaemia
804 reports (19.0%)
#2 Most Reported
Platelet count decreased
593 reports (14.0%)
#3 Most Reported
Pyrexia
440 reports (10.4%)
All PEGINTERFERON ALFA-2B Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Anaemia | 804 | 19.0% | 37 | 184 |
| Platelet count decreased | 593 | 14.0% | 13 | 96 |
| Pyrexia | 440 | 10.4% | 11 | 89 |
| White blood cell count decreased | 420 | 9.9% | 8 | 61 |
| Haemoglobin decreased | 281 | 6.7% | 10 | 70 |
| Neutrophil count decreased | 272 | 6.4% | 7 | 43 |
| Nausea | 269 | 6.4% | 6 | 80 |
| Rash | 269 | 6.4% | 20 | 60 |
| Fatigue | 245 | 5.8% | 4 | 44 |
| Decreased appetite | 224 | 5.3% | 7 | 65 |
| Blood bilirubin increased | 222 | 5.3% | 3 | 31 |
| Malaise | 219 | 5.2% | 13 | 53 |
| Headache | 207 | 4.9% | 7 | 56 |
| Neutropenia | 194 | 4.6% | 21 | 53 |
| No adverse event | 190 | 4.5% | 0 | 0 |
| Pruritus | 182 | 4.3% | 4 | 35 |
| Thrombocytopenia | 167 | 4.0% | 23 | 49 |
| Product quality issue | 159 | 3.8% | 1 | 11 |
| Depression | 152 | 3.6% | 10 | 44 |
| Drug ineffective | 152 | 3.6% | 7 | 26 |
Who Reports PEGINTERFERON ALFA-2B Side Effects? Age & Gender Data
Gender: 48.1% female, 51.9% male. Average age: 57.8 years. Most reports from: JP. View detailed demographics →
Is PEGINTERFERON ALFA-2B Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2000 | 2 | 0 | 2 |
| 2001 | 2 | 0 | 0 |
| 2002 | 6 | 0 | 1 |
| 2003 | 9 | 0 | 4 |
| 2004 | 18 | 0 | 15 |
| 2005 | 19 | 0 | 3 |
| 2006 | 13 | 0 | 2 |
| 2007 | 28 | 0 | 5 |
| 2008 | 23 | 0 | 1 |
| 2009 | 21 | 2 | 5 |
| 2010 | 18 | 0 | 5 |
| 2011 | 32 | 3 | 15 |
| 2012 | 376 | 11 | 162 |
| 2013 | 214 | 12 | 113 |
| 2014 | 1,427 | 43 | 293 |
| 2015 | 227 | 10 | 77 |
| 2016 | 120 | 2 | 38 |
| 2017 | 54 | 7 | 23 |
| 2018 | 35 | 2 | 8 |
| 2019 | 17 | 0 | 5 |
| 2020 | 9 | 0 | 3 |
| 2021 | 1 | 0 | 0 |
| 2022 | 1 | 0 | 0 |
| 2023 | 5 | 0 | 2 |
| 2024 | 4 | 0 | 1 |
| 2025 | 9 | 0 | 0 |
What Is PEGINTERFERON ALFA-2B Used For?
| Indication | Reports |
|---|---|
| Chronic hepatitis c | 1,927 |
| Hepatitis c | 1,246 |
| Malignant melanoma | 134 |
| Product used for unknown indication | 122 |
| Hepatic cirrhosis | 91 |
| Chronic myeloid leukaemia | 53 |
| Chronic hepatitis b | 32 |
| Hepatitis c virus test positive | 20 |
| Hiv infection | 15 |
| Essential thrombocythaemia | 14 |
PEGINTERFERON ALFA-2B vs Alternatives: Which Is Safer?
PEGINTERFERON ALFA-2B vs PEGINTERFERON BETA-1A
PEGINTERFERON ALFA-2B vs PEGINTRON
PEGINTERFERON ALFA-2B vs PEGLOTICASE
PEGINTERFERON ALFA-2B vs PEGUNIGALSIDASE ALFA-IWXJ
PEGINTERFERON ALFA-2B vs PEGVALIASE-PQPZ
PEGINTERFERON ALFA-2B vs PEGVISOMANT
PEGINTERFERON ALFA-2B vs PEGZEREPOETIN ALFA
PEGINTERFERON ALFA-2B vs PEMBROLIZUMAB
PEGINTERFERON ALFA-2B vs PEMETREXED
PEGINTERFERON ALFA-2B vs PEMIGATINIB
Official FDA Label for PEGINTERFERON ALFA-2B
Official prescribing information from the FDA-approved drug label.