Drug Safety Information for NEULASTA (Pegfilgrastim)

Safety-related Labeling Changes for NEULASTA (PEGFILGRASTIM) Biological Drug: FDA Link

Adverse Drug Reactions for NEULASTA* (Pegfilgrastim)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with NEULASTA
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Death1500
2Febrile neutropenia1374
3Pyrexia973
4Neutropenia958
5Bone pain801
6Nausea751
7Fatigue750
8Dyspnoea718
9Diarrhoea615
10Vomiting555
11Pain508
12Drug ineffective494
13Anaemia488
14White blood cell count decreased479
15Asthenia459
16Pneumonia405
17Thrombocytopenia393
18Investigation392
19Dehydration375
20Back pain357

* This side effect also appears in "Top 10 Side Effects of NEULASTA " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking NEULASTA
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Chemotherapy8861
2Product used for unknown indication7195
3Prophylaxis3266
4Neutropenia1873
5Breast cancer1432
6B-cell lymphoma600
7Diffuse large b-cell lymphoma492
8Non-hodgkin's lymphoma316
9White blood cell count decreased238
10Chronic lymphocytic leukaemia199

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for NEULASTA

Total Reports Filed with FDA: 48737


Number of FDA Adverse Event Reports by Patient Age for NEULASTA

Total Reports Filed with FDA: 48737*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Pegfilgrastim (Neulasta)

Charts are based on 48737 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and NEULASTA Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.