PEGASYS: 1,152 Adverse Event Reports & Safety Profile
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1,152
Total FAERS Reports
66 (5.7%)
Deaths Reported
357
Hospitalizations
1,152
As Primary/Secondary Suspect
36
Life-Threatening
18
Disabilities
First Report: 20031219 · Latest Report: 20140605
What Are the Most Common PEGASYS Side Effects?
#1 Most Reported
Anaemia
192 reports (16.7%)
#2 Most Reported
Fatigue
170 reports (14.8%)
#3 Most Reported
White blood cell count decreased
169 reports (14.7%)
All PEGASYS Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Anaemia | 192 | 16.7% | 6 | 74 |
| Fatigue | 170 | 14.8% | 3 | 41 |
| White blood cell count decreased | 169 | 14.7% | 0 | 29 |
| Nausea | 163 | 14.2% | 3 | 39 |
| Rash | 124 | 10.8% | 4 | 27 |
| Pruritus | 115 | 10.0% | 2 | 18 |
| Asthenia | 114 | 9.9% | 2 | 31 |
| Decreased appetite | 90 | 7.8% | 1 | 23 |
| Platelet count decreased | 90 | 7.8% | 6 | 23 |
| Headache | 86 | 7.5% | 3 | 23 |
| Pyrexia | 81 | 7.0% | 9 | 31 |
| Dizziness | 78 | 6.8% | 3 | 32 |
| Weight decreased | 78 | 6.8% | 0 | 19 |
| Haemoglobin decreased | 76 | 6.6% | 5 | 25 |
| Diarrhoea | 75 | 6.5% | 4 | 23 |
| Vomiting | 75 | 6.5% | 2 | 30 |
| Pain | 65 | 5.6% | 3 | 15 |
| Dysgeusia | 64 | 5.6% | 1 | 10 |
| Depression | 60 | 5.2% | 1 | 18 |
| Dyspnoea | 60 | 5.2% | 1 | 16 |
Who Reports PEGASYS Side Effects? Age & Gender Data
Average age: 54.0 years. Most reports from: US. View detailed demographics →
Is PEGASYS Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2003 | 1 | 0 | 0 |
| 2004 | 2 | 0 | 1 |
| 2005 | 4 | 0 | 0 |
| 2008 | 8 | 1 | 5 |
| 2009 | 3 | 0 | 2 |
| 2010 | 2 | 0 | 0 |
| 2011 | 21 | 2 | 11 |
| 2012 | 109 | 3 | 34 |
| 2013 | 376 | 14 | 127 |
| 2014 | 268 | 24 | 94 |
What Is PEGASYS Used For?
| Indication | Reports |
|---|---|
| Hepatitis c | 679 |
| Chronic hepatitis c | 270 |
| Product used for unknown indication | 62 |
| Hepatitis b | 25 |
| Hepatic cirrhosis | 10 |
| Chronic hepatitis b | 6 |
PEGASYS vs Alternatives: Which Is Safer?
PEGASYS vs PEGCETACOPLAN
PEGASYS vs PEGFILGRASTIM
PEGASYS vs PEGFILGRASTIM-APGF
PEGASYS vs PEGFILGRASTIM-BMEZ
PEGASYS vs PEGFILGRASTIM-CBQV
PEGASYS vs PEGFILGRASTIM-JMDB
PEGASYS vs PEGINTERFERON ALFA
PEGASYS vs PEGINTERFERON ALFA-2A
PEGASYS vs PEGINTERFERON ALFA-2A OR PEGINTERFERON ALFA-2B
PEGASYS vs PEGINTERFERON ALFA-2A OR PEGINTERFERON ALFA-2B OR PEGINTERFERON BETA-1A OR PEGINTERFERON LAMBDA-1A
Official FDA Label for PEGASYS
Official prescribing information from the FDA-approved drug label.