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Neupogen (Filgrastim) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Neupogen (Filgrastim) 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 (850)
Death (77)
Life Threatening Events (34)
Disability (8)

Reports by Reaction Type

Febrile Neutropenia (89)Neutropenia (70)Pneumonia (65)Pyrexia (53)White Blood Cell Count Decreased (49)Deep Vein Thrombosis (44)Drug Ineffective (41)Diarrhoea (38)Bone Pain (36)Infection (35)Leukopenia (35)Malaise (29)

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

Possible Neupogen side effects in male

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

Patient: male, weighing 95.0 kg (209.0 pounds)

Reactions: Cranial Nerve Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cyclophosphamide
    Dosage: third maintenance cycle
    Indication: Diffuse Large B-Cell Lymphoma
    Start date: 2010-09-06

Cyclophosphamide

Doxorubicin HCL
    Indication: Diffuse Large B-Cell Lymphoma

Doxorubicin HCL
    Dosage: third maintenance cycle
    Start date: 2010-09-06

Neupogen
    Indication: Diffuse Large B-Cell Lymphoma

Neupogen
    Dosage: third maintenance cycle
    Start date: 2010-09-07

Prednisone TAB
    Administration route: Oral
    Indication: Diffuse Large B-Cell Lymphoma

Prednisone TAB
    Dosage: third maintenance cycle
    Administration route: Oral
    Start date: 2010-09-06

Rituximab
    Dosage: third maintenance cycle
    Indication: Diffuse Large B-Cell Lymphoma
    Start date: 2010-09-06

Rituximab
    Start date: 2010-11-29
    End date: 2011-03-21

Vincristine
    Dosage: third maintenance cycle
    Start date: 2010-09-06

Vincristine
    Indication: Diffuse Large B-Cell Lymphoma



Possible Neupogen 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 Neupogen side effects in female

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

Patient: female

Reactions: Therapeutic Response Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Neupogen



Possible Neupogen side effects in 62 year old female

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

Patient: 62 year old female, weighing 119.0 kg (261.8 pounds)

Reactions: Back Pain, Hypersensitivity, Vomiting, Nausea, Hypotension, Tachycardia, Hyperhidrosis, Heart Rate Increased, Dizziness, Tachypnoea, Hypertension, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Neupogen

Other drugs received by patient: Dilaudid; Gabapentin; Dexamethasone; Levemir; Granisetron; Cesamet



Possible Neupogen side effects in female

Reported by a consumer/non-health professional from Canada on 2012-08-23

Patient: female

Reactions: NO Therapeutic Response

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Neupogen



Possible Neupogen side effects in 71 year old female

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

Patient: 71 year old female

Reactions: Breast Cancer Metastatic, Metastases To Liver, Urticaria, Metastases To Central Nervous System, Metastases To Bone, Metastases To Lung, Arthropod Bite

Adverse event resulted in: death

Drug(s) suspected as cause:
Neupogen
    Dosage: unk
    Indication: Chemotherapy
    Start date: 2011-01-31
    End date: 2011-06-10

Xgeva
    Dosage: unk
    Indication: Metastases To Bone

Other drugs received by patient: Navelbine



Possible Neupogen side effects in 56 year old female

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

Patient: 56 year old female

Reactions: Weight Decreased, White Blood Cell Count Decreased, Vomiting, Dyspnoea, Anaemia, Headache

Drug(s) suspected as cause:
Boceprevir
    Dosage: 4 df, tid
    Administration route: Oral
    Indication: Hepatitis C

Neupogen
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Pegasys
    Dosage: 90 mug, qwk

Pegasys
    Dosage: 90 mug, qwk
    Indication: Hepatitis C
    Start date: 2011-12-20

Ribasphere
    Dosage: 1200 mg, qd
    Indication: Hepatitis C
    Start date: 2011-12-20

Other drugs received by patient: Klor-CON; Ibuprofen; Furosemide; Amlodipine



Possible Neupogen side effects in 67 year old female

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

Patient: 67 year old female, weighing 46.0 kg (101.2 pounds)

Reactions: Anaemia, Circulatory Collapse

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cyclophosphamide
    Dosage: unk
    Indication: Diffuse Large B-Cell Lymphoma
    Start date: 2011-10-05

Doxorubicin Hydrochloride
    Dosage: 72 mg, unk
    Indication: Diffuse Large B-Cell Lymphoma
    Start date: 2011-10-05

Neupogen
    Dosage: 6 mg, unk
    Indication: Diffuse Large B-Cell Lymphoma
    Start date: 2011-10-06

Prednisone TAB
    Dosage: 100 mg, unk
    Administration route: Oral
    Indication: Diffuse Large B-Cell Lymphoma
    Start date: 2011-10-05

Rituximab
    Dosage: 540 mg, unk
    Indication: Diffuse Large B-Cell Lymphoma
    Start date: 2011-10-06



Possible Neupogen side effects in female

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

Patient: female

Reactions: Pain in Extremity, Gait Disturbance

Drug(s) suspected as cause:
Neupogen



Possible Neupogen side effects in 59 year old female

Reported by a physician from United States on 2012-08-20

Patient: 59 year old female, weighing 58.9 kg (129.6 pounds)

Reactions: White Blood Cell Count Decreased, Blood Bilirubin Increased, Jaundice, Hepatic Function Abnormal, Haematuria, Alanine Aminotransferase Increased, Cystitis, Fatigue, Diarrhoea, Aspartate Aminotransferase Increased, Platelet Count Decreased, Neutropenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Fluconazole
    Dosage: unk
    Indication: Antifungal Treatment
    End date: 2012-07-24

Mozobil
    Dosage: unk, 2 cycles
    Indication: Acute Myeloid Leukaemia

Neupogen
    Dosage: unk, 2 cycles
    Indication: Acute Myeloid Leukaemia

Sorafenib
    Dosage: unk, 2 cycles
    Indication: Acute Myeloid Leukaemia

Other drugs received by patient: Antibacterial NOS; Antivirals NOS



Possible Neupogen side effects in 71 year old female

Reported by a physician from United States on 2012-08-17

Patient: 71 year old female

Reactions: Breast Cancer Metastatic, Urticaria, Arthropod Bite

Adverse event resulted in: death

Drug(s) suspected as cause:
Neupogen
    Dosage: unk
    Indication: Chemotherapy
    Start date: 2011-01-31
    End date: 2011-06-10

Xgeva
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Navelbine



Possible Neupogen side effects in female

Reported by a physician from United States on 2012-08-17

Patient: female, weighing 47.6 kg (104.7 pounds)

Reactions: White Blood Cell Count Decreased, Metastases To Liver, Bone Pain

Drug(s) suspected as cause:
Neupogen

Other drugs received by patient: Herceptin; Taxotere; Carboplatin



Possible Neupogen side effects in

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

Patient:

Reactions: Hypersensitivity

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Neupogen



Possible Neupogen side effects in male

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

Patient: male

Reactions: Influenza Like Illness

Drug(s) suspected as cause:
Neupogen
    Dosage: 480 mug, q3wk
    Indication: Product Used FOR Unknown Indication
    Start date: 2005-01-01
    End date: 2010-01-01

Neupogen
    Indication: Bone Marrow Transplant



Possible Neupogen side effects in female

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

Patient: female

Reactions: Accidental Exposure

Drug(s) suspected as cause:
Neupogen



Possible Neupogen side effects in female

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

Patient: female

Reactions: Neutrophil Count Increased, Bone Pain, Headache

Drug(s) suspected as cause:
Neupogen



Possible Neupogen side effects in male

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

Patient: male

Reactions: Drug Ineffective, Body Temperature Decreased, Oral Fungal Infection

Drug(s) suspected as cause:
Neupogen



Possible Neupogen side effects in female

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

Patient: female

Reactions: Nausea, Headache

Drug(s) suspected as cause:
Neupogen

Other drugs received by patient: Victrelis



Possible Neupogen side effects in male

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

Patient: male

Reactions: Chest Pain

Drug(s) suspected as cause:
Neupogen

Other drugs received by patient: Antineoplastic Agents



Possible Neupogen side effects in 65 year old male

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

Patient: 65 year old male

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Neupogen

Other drugs received by patient: Simvastatin; Glucosamine + Chondroitin / 01430901 /; Fish OIL



Possible Neupogen 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 Neupogen side effects in 54 year old male

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

Patient: 54 year old male

Reactions: Abdominal Discomfort, Fatigue

Drug(s) suspected as cause:
Neupogen

Other drugs received by patient: Pegasys



Possible Neupogen side effects in 82 year old female

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

Patient: 82 year old female

Reactions: Urticaria, Neutropenia, Rash

Drug(s) suspected as cause:
Neulasta
    Dosage: 6 mg, q3wk
    Indication: Breast Cancer
    Start date: 2012-01-04
    End date: 2012-02-01

Neupogen
    Indication: Breast Cancer
    Start date: 2012-03-08

Other drugs received by patient: Dexamethasone; Cytoxan; Enalapril Maleate; Metoprolol Tartrate; Taxotere



Possible Neupogen side effects in

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

Patient:

Reactions: Neutrophil Count Increased, Bone Pain, Headache

Drug(s) suspected as cause:
Neupogen



Possible Neupogen 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 Neupogen side effects in female

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

Patient: female

Reactions: Product Colour Issue, Incorrect Product Storage

Drug(s) suspected as cause:
Neupogen



Possible Neupogen side effects in 36 year old female

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

Patient: 36 year old female

Reactions: Stomatitis, Oral Pain, Mouth Haemorrhage

Drug(s) suspected as cause:
Neulasta
    Dosage: unk unk, after chemo
    Indication: Chemotherapy
    Start date: 2012-07-13

Neupogen
    Dosage: unk unk, after chemo
    Indication: Chemotherapy
    Start date: 2012-07-18

Other drugs received by patient: Fluorouracil; Zofran; Multi-Vitamins; Benadryl; Cytoxan; Adriamycin PFS



Possible Neupogen side effects in female

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

Patient: female

Reactions: Injection Site Pain

Drug(s) suspected as cause:
Neupogen



Possible Neupogen side effects in

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

Patient:

Reactions: White Blood Cell Count Abnormal, Infection Susceptibility Increased

Drug(s) suspected as cause:
Neupogen



Possible Neupogen side effects in female

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

Patient: female

Reactions: White Blood Cell Count Decreased

Drug(s) suspected as cause:
Neupogen
    Indication: Neutropenia

Neupogen
    Dosage: 300 mug, qd
    Indication: Chemotherapy
    Start date: 2012-06-26
    End date: 2012-06-29

Other drugs received by patient: Cytoxan; Taxotere; Herceptin

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