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Neulasta (Pegfilgrastim) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Neulasta (Pegfilgrastim) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (861)
Death (127)
Life Threatening Events (36)
Disability (5)

Reports by Reaction Type

Febrile Neutropenia (100)Neutropenia (83)Drug Ineffective (68)Dyspnoea (65)Pyrexia (63)Bone Pain (56)Fatigue (56)Anaemia (44)Chest Pain (39)Nausea (39)Diarrhoea (39)Back Pain (37)

Below are a few examples of reports where side effects / adverse reactions may be related to Neulasta (Pegfilgrastim). For a complete list or a specific selection of reports, please use the links above.

Possible Neulasta side effects in 28 year old female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 28 year old female, weighing 77.1 kg (169.6 pounds)

Reactions: Breast Cancer, Drug Ineffective, Nausea, Bone Pain, Headache, Anxiety, Pneumothorax, Depression, Eye Pruritus

Drug(s) suspected as cause:
Neulasta
    Indication: White Blood Cell Count Decreased
    Start date: 2012-07-01

Nexium
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease
    Start date: 2012-07-01

Prilosec
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease
    Start date: 2002-01-01
    End date: 2012-07-01

Steroid Therapy

Other drugs received by patient: Dexamethasone; Kytril; Promethazine; IV Fluids; Sertraline Hydrochloride; Marinol; Xanax; Singulair; Allegra; Hydrocodone Acetominophen; Fioricet



Possible Neulasta side effects in female

Reported by a pharmacist from Canada on 2012-08-27

Patient: female

Reactions: Intestinal Perforation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Neulasta

Other drugs received by patient: Cyclophosphamide; Doxorubicin Hydrochloride



Possible Neulasta side effects in 47 year old female

Reported by a health professional (non-physician/pharmacist) from Netherlands on 2012-08-27

Patient: 47 year old female

Reactions: Bone Pain, Musculoskeletal Disorder

Drug(s) suspected as cause:
Neulasta

Other drugs received by patient: Antineoplastic Agents; Acetaminophen; Metoclopramide; Dexamethasone; Emend; Ciprofloxacin HCL



Possible Neulasta side effects in 62 year old female

Reported by a physician from Finland on 2012-08-27

Patient: 62 year old female

Reactions: Back Pain, Dysphagia, Stomatitis, Dyspnoea, Pain in Extremity, Hypotension, Bone Pain, Constipation, Abdominal Pain Upper, Joint Stiffness, Myalgia, Malaise, Insomnia, Oedema Peripheral, Musculoskeletal Stiffness, Gait Disturbance, Candidiasis

Drug(s) suspected as cause:
Docetaxel
    Dosage: 80 mg/m2, unk
    Indication: Metastasis
    Start date: 2012-04-26
    End date: 2012-04-28

Neulasta
    Dosage: 6 mg, unk
    Indication: Chemotherapy
    Start date: 2012-04-28
    End date: 2012-06-11

Neupogen
    Dosage: unk
    Indication: Chemotherapy
    Start date: 2012-07-21
    End date: 2012-07-27



Possible Neulasta side effects in female

Reported by a physician from Germany on 2012-08-27

Patient: female

Reactions: Drug Ineffective, Lymphopenia, Febrile Neutropenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Neulasta

Other drugs received by patient: Doxorubicin Hydrochloride; Prednisone TAB; Rituximab; Vincristine; Cyclophosphamide



Possible Neulasta side effects in male

Reported by a physician from Germany on 2012-08-24

Patient: male

Reactions: Febrile Neutropenia, Skin Infection, Neutropenia, Pneumonitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cyclophosphamide
    Dosage: 1500 mg, unk
    Indication: B-Cell Lymphoma
    Start date: 2012-02-02
    End date: 2012-04-17

Doxorubicin Hydrochloride
    Dosage: 100 mg, unk
    Indication: B-Cell Lymphoma
    Start date: 2012-02-02
    End date: 2012-04-17

Neulasta
    Dosage: 6 mg, unk
    Indication: B-Cell Lymphoma
    Start date: 2012-02-06
    End date: 2012-04-20

Prednisolone
    Dosage: 100 mg, unk
    Administration route: Oral
    Indication: B-Cell Lymphoma
    Start date: 2012-02-02
    End date: 2012-04-21

Rituximab
    Dosage: 750 mg, unk
    Indication: B-Cell Lymphoma
    Start date: 2012-02-01
    End date: 2012-04-16

Vincristine
    Dosage: 2 mg, unk
    Indication: B-Cell Lymphoma
    Start date: 2012-02-02
    End date: 2012-04-17

Other drugs received by patient: MST / 00036302 /; Novalgin / 00169801 /; Rulid; Pantoprazole; Paspertin / 00041902 /; Acyclovir; Electrolytes NOS W / Macrogol 3350; Dipyrone INJ; Metoclopramide; Acyclovir



Possible Neulasta side effects in 50 year old female

Reported by a physician from United Kingdom on 2012-08-23

Patient: 50 year old female, weighing 68.0 kg (149.6 pounds)

Reactions: Swelling Face, Dyspnoea, Body Temperature Increased, Drug Ineffective, Neutropenic Sepsis, Anaphylactic Reaction, Swollen Tongue, Erythema, Oedema Mucosal, Neutropenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Neulasta

Other drugs received by patient: Fluorouracil; Dexamethasone; Zofran; Metoclopramide; Epirubicin; Cyclophosphamide



Possible Neulasta side effects in 44 year old female

Reported by a physician from Germany on 2012-08-23

Patient: 44 year old female, weighing 72.0 kg (158.4 pounds)

Reactions: Venous Thrombosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cyclophosphamide
    Dosage: 1110 mg, q3wk
    Indication: Breast Cancer
    Start date: 2010-08-03
    End date: 2010-10-05

Neulasta
    Dosage: 6 mg, qd
    Indication: Colony Stimulating Factor Prophylaxis
    Start date: 2010-10-06

Taxotere
    Dosage: 138.75 mg, q3wk
    Indication: Breast Cancer
    Start date: 2010-08-03
    End date: 2010-10-05

Other drugs received by patient: Dexamethasone Sodium Phosphate; Dexamethasone Sodium Phosphate; Palonosetron; Mesna; Bromocriptin; Dexamethasone Sodium Phosphate; Mesna



Possible Neulasta side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-23

Patient: female, weighing 87.7 kg (192.9 pounds)

Reactions: Anxiety, Chest Pain, Stress

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cisplatin
    Dosage: every 2 weeks x 3 cycles
    Start date: 2012-07-12
    End date: 2012-08-09

Gemcitabine Hydrochloride
    Dosage: every 2 weeks x 3 cycles
    Start date: 2012-07-12
    End date: 2012-08-09

Neulasta
    Dosage: day 2 of cycle x 3
    Start date: 2012-07-08
    End date: 2012-08-11



Possible Neulasta side effects in 47 year old female

Reported by a health professional (non-physician/pharmacist) from Australia on 2012-08-23

Patient: 47 year old female

Reactions: Abdominal Pain, Bone Pain, Neutropenia, Muscle Spasms

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Neulasta

Other drugs received by patient: Cyclophosphamide; Docetaxel



Possible Neulasta side effects in 50 year old female

Reported by a pharmacist from United Kingdom on 2012-08-23

Patient: 50 year old female

Reactions: Febrile Neutropenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Neulasta

Other drugs received by patient: Antineoplastic Agents; Ciprofloxacin



Possible Neulasta side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: female

Reactions: Death, Drug Ineffective, Pseudomonas Infection, Pancytopenia, Neutropenia

Adverse event resulted in: death

Drug(s) suspected as cause:
Neulasta

Other drugs received by patient: Etoposide; Topotecan Hydrochloride; Cisplatin



Possible Neulasta side effects in 16 year old male

Reported by a pharmacist from Australia on 2012-08-22

Patient: 16 year old male

Reactions: LIP Swelling, Swelling Face, Anaphylactic Reaction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Neulasta

Other drugs received by patient: Doxorubicin HCL; Vinblastine Sulfate; Dacarbazine; Bleomycin



Possible Neulasta side effects in 67 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-22

Patient: 67 year old female

Reactions: Fatigue, Nausea, Herpes Zoster

Drug(s) suspected as cause:
Ebastine
    Dosage: 10 mg, unk
    Indication: Faecaloma

Ebastine
    Indication: Pruritus

Halaven
    Dosage: unk
    Indication: Faecaloma
    Start date: 2012-06-19

Halaven
    Dosage: 1.58 mg, unk
    Indication: Pruritus
    Start date: 2012-06-26

Loratadine
    Indication: Pruritus

Loratadine
    Indication: Faecaloma

Neulasta
    Indication: Pruritus

Neulasta
    Dosage: unk
    Indication: Faecaloma

Solu-Medrol
    Dosage: 20 mg, unk
    Indication: Faecaloma
    Start date: 2012-06-26

Solu-Medrol
    Indication: Pruritus

Zantac
    Indication: Pruritus

Zantac
    Dosage: 50 mg, unk
    Indication: Faecaloma
    Start date: 2012-06-26

Zofran
    Dosage: 8 mg, unk
    Indication: Faecaloma
    Start date: 2012-06-26

Zofran
    Indication: Pruritus

Other drugs received by patient: Acebutolol; Nexium



Possible Neulasta side effects in 45 year old female

Reported by a health professional (non-physician/pharmacist) from Netherlands on 2012-08-21

Patient: 45 year old female

Reactions: Ear Pain, Muscular Weakness, Local Swelling, Headache, Sense of Oppression, Pain in JAW

Drug(s) suspected as cause:
Neulasta
    Dosage: 6 mg, q3wk
    Indication: Chemotherapy
    Start date: 2012-07-25

Prolia
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Metoclopramide; Ciprofloxacin; Diclofenac; Aprepitant; Metamucil / 00029101 /; Dexamethasone; Pantoprazole; Calci Chew D3; Antineoplastic Agents



Possible Neulasta side effects in female

Reported by a consumer/non-health professional from France on 2012-08-21

Patient: female

Reactions: Fatigue, Nausea, Herpes Zoster

Drug(s) suspected as cause:
Ebsatine
    Indication: Faecaloma

Ebsatine
    Indication: Pruritus

Halaven
    Dosage: 1.58 mg/day
    Start date: 2012-06-26

Halaven
    Dosage: unk
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-06-19

Loratadine
    Indication: Pruritus

Loratadine
    Indication: Faecaloma

Neulasta
    Dosage: unk
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-06-27

Solu-Medrol
    Dosage: 20 mg/day
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-06-26

Zantac
    Dosage: 50 mg/day
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-06-26

Zofran
    Dosage: 8 mg/day
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-06-26

Other drugs received by patient: Acebutolol; Nexium



Possible Neulasta side effects in female

Reported by a physician from United States on 2012-08-21

Patient: female

Reactions: Visual Impairment, Dizziness, Asthenia, Bladder Cancer

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Neulasta

Other drugs received by patient: Antineoplastic Agents



Possible Neulasta side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Neulasta



Possible Neulasta side effects in female

Reported by a physician from Denmark on 2012-08-21

Patient: female, weighing 74.0 kg (162.8 pounds)

Reactions: Back Pain, Pulmonary Embolism

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cyclophosphamide
    Indication: Diffuse Large B-Cell Lymphoma
    Start date: 2012-02-07

Cyclophosphamide
    Dosage: 05/mar/2012: last dose prioe to onset of sae
    Start date: 2012-03-05

Doxorubicin HCL
    Indication: Diffuse Large B-Cell Lymphoma
    Start date: 2012-02-07

Doxorubicin HCL
    Start date: 2012-03-05

Mabthera
    Dosage: last dose prior to sae was on 13/feb/2012
    Start date: 2012-03-05

Mabthera
    Indication: Diffuse Large B-Cell Lymphoma
    Start date: 2012-02-07

Mabthera
    Start date: 2012-02-13

Neulasta
    Indication: Diffuse Large B-Cell Lymphoma
    Start date: 2012-02-10
    End date: 2012-02-10

Neulasta
    Start date: 2012-02-23

Neulasta
    Start date: 2012-03-08

Prednisone TAB
    Dosage: last dose prior to sae was on 9/mar/2012
    Administration route: Oral
    Start date: 2012-03-05

Prednisone TAB
    Administration route: Oral
    Start date: 2012-02-27
    End date: 2012-02-27

Prednisone TAB
    Administration route: Oral
    Start date: 2012-02-20
    End date: 2012-02-24

Prednisone TAB
    Administration route: Oral
    Indication: Diffuse Large B-Cell Lymphoma
    Start date: 2012-02-07

Vincristine
    Start date: 2012-03-05

Vincristine
    Indication: Diffuse Large B-Cell Lymphoma
    Start date: 2012-02-07

Other drugs received by patient: Acyclovir; Ondansetron; Tramadol HCL; Lansoprazole; Acyclovir; Lansoprazole; Bactrim



Possible Neulasta side effects in 22 year old female

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: 22 year old female

Reactions: Dysphagia, Pain, Bone Pain, Oropharyngeal Pain, Pharyngeal Oedema, Swelling, Dysuria, Heart Rate Increased

Drug(s) suspected as cause:
Neulasta

Other drugs received by patient: Dacarbazine; Tylenol PM; Motrin; Claritin / 00917501 /; Adriamycin PFS; Tylenol (Caplet); Bleomycin; Reclipsen; Vinblastine Sulfate



Possible Neulasta side effects in female

Reported by a physician from Germany on 2012-08-20

Patient: female

Reactions: Drug Ineffective, Lymphopenia, Febrile Neutropenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Neulasta

Other drugs received by patient: Doxorubicin HCL; Rituximab; Prednisone TAB; Cyclophosphamide; Vincristine



Possible Neulasta side effects in 77 year old female

Reported by a health professional (non-physician/pharmacist) from Netherlands on 2012-08-20

Patient: 77 year old female, weighing 85.0 kg (187.0 pounds)

Reactions: Myalgia, Dyspnoea, Malaise, Palpitations, Sepsis, Pyrexia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Neulasta

Other drugs received by patient: Docetaxel; Doxorubicin Hydrochloride



Possible Neulasta side effects in 18 year old

Reported by a physician from Germany on 2012-08-17

Patient: 18 year old

Reactions: Abdominal Discomfort

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Adriamycin PFS
    Dosage: 35 mg/m2, unk
    Indication: Hodgkin's Disease

Bleomycin Sulfate
    Dosage: 10 mg/m2, unk
    Indication: Hodgkin's Disease

Cotrim

Cyclophosphamide
    Dosage: 1250 mg/m2, unk
    Indication: Hodgkin's Disease

Etoposide
    Dosage: 200 mg/m2, unk
    Indication: Hodgkin's Disease

Neulasta
    Dosage: 6 mg, unk
    Indication: Chemotherapy
    Start date: 2011-10-15

Prednisone TAB
    Dosage: 40 mg/m2, unk
    Indication: Hodgkin's Disease

Procarbazine Hydrochloride
    Dosage: 100 mg/m2, unk
    Indication: Hodgkin's Disease

Vincristine
    Dosage: 1.4 mg/m2, unk
    Indication: Hodgkin's Disease



Possible Neulasta side effects in 63 year old male

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: 63 year old male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Neulasta



Possible Neulasta side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-16

Patient: male

Reactions: Rash Generalised, Urticaria, Bone Pain

Drug(s) suspected as cause:
Neulasta
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Neupogen
    Dosage: unk unk, per chemo regim
    Indication: Chemotherapy



Possible Neulasta side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-16

Patient: female

Reactions: Chest Pain

Drug(s) suspected as cause:
Neulasta
    Indication: Product Used FOR Unknown Indication

Neupogen
    Indication: Product Used FOR Unknown Indication



Possible Neulasta side effects in 76 year old female

Reported by a physician from United States on 2012-08-16

Patient: 76 year old female

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Neulasta
    Indication: Product Used FOR Unknown Indication

Neupogen
    Indication: Product Used FOR Unknown Indication



Possible Neulasta side effects in

Reported by a consumer/non-health professional from United States on 2012-08-16

Patient:

Reactions: Drug Ineffective, Blood Count Abnormal

Drug(s) suspected as cause:
Neulasta
    Dosage: unk
    Indication: Leukaemia

Neulasta

Neupogen
    Dosage: unk
    Indication: Leukaemia

Neupogen

Other drugs received by patient: Oxaliplatin; Gemcitabine Hydrochloride



Possible Neulasta side effects in 48 year old female

Reported by a consumer/non-health professional from United States on 2012-08-16

Patient: 48 year old female

Reactions: Therapeutic Response Decreased, White Blood Cell Count Decreased, Bone Pain

Drug(s) suspected as cause:
Neulasta
    Dosage: 6 mg, unk
    Indication: Chemotherapy
    Start date: 2011-08-16

Neupogen
    Indication: Chemotherapy

Neupogen
    Dosage: unk
    Indication: Peripheral Blood Stem Cell Apheresis
    Start date: 2010-07-01
    End date: 2010-08-01



Possible Neulasta side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-16

Patient: female

Reactions: Malaise, Chest Discomfort, Feeling Hot, Erythema

Drug(s) suspected as cause:
Neulasta
    Dosage: unk
    Indication: Chemotherapy

Neupogen
    Dosage: unk
    Indication: Chemotherapy

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