PEGFILGRASTIM

N/A

Manufactured by Amgen, Inc

146,341 FDA adverse event reports analyzed

Last updated: 2026-04-14

About PEGFILGRASTIM

PEGFILGRASTIM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Amgen, Inc. The most commonly reported adverse reactions for PEGFILGRASTIM include DEVICE ADHESION ISSUE, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS, UNINTENTIONAL MEDICAL DEVICE REMOVAL, DEVICE MALFUNCTION, DEVICE USE ERROR. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for PEGFILGRASTIM.

Top Adverse Reactions

DEVICE ADHESION ISSUE11,436 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS10,236 reports
UNINTENTIONAL MEDICAL DEVICE REMOVAL8,931 reports
DEVICE MALFUNCTION6,834 reports
DEVICE USE ERROR6,023 reports
DEVICE ISSUE5,094 reports
ACCIDENTAL EXPOSURE TO PRODUCT4,983 reports
OFF LABEL USE3,759 reports
FEBRILE NEUTROPENIA3,697 reports
DEVICE OCCLUSION3,272 reports
BONE PAIN2,942 reports
DEATH2,757 reports
NEUTROPENIA2,609 reports
FATIGUE2,555 reports
PYREXIA2,478 reports
NAUSEA2,417 reports
DRUG DOSE OMISSION2,104 reports
DRUG DOSE OMISSION BY DEVICE2,086 reports
DIARRHOEA1,921 reports
PAIN1,735 reports
ALOPECIA1,732 reports
DYSPNOEA1,600 reports
INTERCEPTED PRODUCT PREPARATION ERROR1,556 reports
OCCUPATIONAL EXPOSURE TO PRODUCT1,412 reports
VOMITING1,406 reports
ANAEMIA1,404 reports
APPLICATION SITE HAEMORRHAGE1,396 reports
DEVICE LEAKAGE1,384 reports
DEVICE PHYSICAL PROPERTY ISSUE1,374 reports
APPLICATION SITE PAIN1,262 reports
WHITE BLOOD CELL COUNT DECREASED1,261 reports
ASTHENIA1,189 reports
HYPERHIDROSIS1,119 reports
THROMBOCYTOPENIA1,117 reports
PNEUMONIA1,067 reports
ARTHRALGIA1,055 reports
UNDERDOSE1,053 reports
BACK PAIN1,012 reports
DRUG INEFFECTIVE1,005 reports
MALAISE983 reports
HEADACHE953 reports
CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR884 reports
DECREASED APPETITE866 reports
PRODUCT STORAGE ERROR862 reports
PAIN IN EXTREMITY840 reports
NEUTROPHIL COUNT DECREASED831 reports
DEVICE FAILURE830 reports
NEUROPATHY PERIPHERAL824 reports
HOSPITALISATION818 reports
CONSTIPATION813 reports
RASH781 reports
SEPSIS748 reports
DEHYDRATION721 reports
COUGH694 reports
DIZZINESS686 reports
MYALGIA683 reports
PLATELET COUNT DECREASED670 reports
ABDOMINAL PAIN668 reports
INFECTION633 reports
CHEST PAIN613 reports
HYPOTENSION600 reports
GENERAL PHYSICAL HEALTH DETERIORATION562 reports
LEUKOPENIA558 reports
PANCYTOPENIA553 reports
WEIGHT DECREASED550 reports
DISEASE PROGRESSION546 reports
ANXIETY514 reports
URINARY TRACT INFECTION509 reports
PRODUCT PREPARATION ERROR499 reports
INCORRECT DOSE ADMINISTERED BY DEVICE497 reports
FALL496 reports
DEVICE POWER SOURCE ISSUE484 reports
HAEMOGLOBIN DECREASED480 reports
NEEDLE ISSUE480 reports
FEELING ABNORMAL474 reports
PRODUCT DOSE OMISSION465 reports
INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION461 reports
WHITE BLOOD CELL COUNT INCREASED450 reports
INSOMNIA440 reports
MUCOSAL INFLAMMATION429 reports
INCORRECT DOSE ADMINISTERED422 reports
APPLICATION SITE DISCOMFORT414 reports
UNEVALUABLE EVENT406 reports
HAIR TEXTURE ABNORMAL404 reports
HAIR COLOUR CHANGES401 reports
PSYCHOLOGICAL TRAUMA400 reports
DEVICE ELECTRICAL FINDING399 reports
INVESTIGATION392 reports
PULMONARY EMBOLISM392 reports
PARAESTHESIA375 reports
ERYTHEMA374 reports
INJECTION SITE PAIN373 reports
STOMATITIS368 reports
MADAROSIS367 reports
ABDOMINAL PAIN UPPER360 reports
HYPERSENSITIVITY359 reports
INCORRECT DISPOSAL OF PRODUCT357 reports
INTERCEPTED PRODUCT ADMINISTRATION ERROR356 reports
SYNCOPE353 reports
PRURITUS348 reports

Report Outcomes

Out of 96,810 classified reports for PEGFILGRASTIM:

Serious 29.0%Non-Serious 71.0%

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

Female52,132 (65.6%)
Male27,057 (34.0%)
Unknown323 (0.4%)

Reports by Age

Age 651,932 reports
Age 661,917 reports
Age 671,877 reports
Age 681,873 reports
Age 691,827 reports
Age 631,809 reports
Age 611,794 reports
Age 621,753 reports
Age 641,742 reports
Age 701,726 reports
Age 721,674 reports
Age 601,620 reports
Age 581,615 reports
Age 711,609 reports
Age 591,604 reports
Age 731,530 reports
Age 741,485 reports
Age 561,442 reports
Age 571,370 reports
Age 751,326 reports

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

Frequently Asked Questions

How many FDA adverse event reports are associated with PEGFILGRASTIM?

This profile reflects 146,341 FDA FAERS reports that mention PEGFILGRASTIM. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for PEGFILGRASTIM?

Frequently reported terms in FAERS include DEVICE ADHESION ISSUE, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS, UNINTENTIONAL MEDICAL DEVICE REMOVAL, DEVICE MALFUNCTION, DEVICE USE ERROR, DEVICE ISSUE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures PEGFILGRASTIM?

Labeling and FAERS entries often list Amgen, Inc in connection with PEGFILGRASTIM. Always verify the specific product and NDC with your pharmacist.

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.