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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 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 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 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 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 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 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 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 male

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

Patient: male

Reactions: Diarrhoea

Drug(s) suspected as cause:
Neupogen



Possible Neupogen side effects in female

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

Patient: female

Reactions: Injection Site Extravasation, Underdose

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: Pain

Drug(s) suspected as cause:
Neupogen

Other drugs received by patient: Herceptin; Taxotere; Carboplatin



Possible Neupogen side effects in

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

Patient:

Reactions: Bone Pain

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Neupogen
    Dosage: 480 mug, unk
    Indication: Product Used FOR Unknown Indication

Neupogen
    Dosage: 480 mug, unk

Neupogen

Neupogen



Possible Neupogen side effects in 51 year old female

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

Patient: 51 year old female, weighing 114.3 kg (251.4 pounds)

Reactions: Dyspnoea, Cough

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Neupogen



Possible Neupogen side effects in

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

Patient:

Reactions: Bone Pain

Drug(s) suspected as cause:
Neupogen



Possible Neupogen side effects in

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

Patient:

Reactions: Incorrect Route of Drug Administration

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: Cutaneous Vasculitis

Drug(s) suspected as cause:
Neupogen



Possible Neupogen side effects in 49 year old male

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

Patient: 49 year old male, weighing 80.0 kg (176.0 pounds)

Reactions: Burning Sensation, Nausea, Arthralgia, Oedema Peripheral

Drug(s) suspected as cause:
Aranesp
    Dosage: unk
    Indication: Anaemia of Malignant Disease
    Start date: 2011-08-13

Neulasta
    Dosage: 6 mg, unk
    Indication: Chemotherapy
    Start date: 2011-08-13

Neupogen
    Dosage: unk
    Indication: Chemotherapy
    Start date: 2011-08-15

Nplate
    Dosage: 500 mug, prn
    Indication: Idiopathic Thrombocytopenic Purpura
    Start date: 2011-08-15

Other drugs received by patient: Gemzar; Oxycodone; Bactroban; Ondansetron; Oxaliplatin; Nystatin; Remeron; Melatonin; Restoril; Aldactone



Possible Neupogen side effects in 57 year old female

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

Patient: 57 year old female

Reactions: Headache

Drug(s) suspected as cause:
Neupogen

Other drugs received by patient: Nexium; Crestor; Hydrochlorothiazide; Atenolol; Plavix



Possible Neupogen side effects in 53 year old female

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

Patient: 53 year old female, weighing 77.1 kg (169.6 pounds)

Reactions: Drug Ineffective, Condition Aggravated

Drug(s) suspected as cause:
Enbrel
    Dosage: 25 mg, 2 times/wk
    Indication: Product Used FOR Unknown Indication

Neupogen
    Dosage: 300 mug, unk
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Triamterene and Hydrochlorothiazide; Pepcid AC; Chromium Chloride; Drospirenone and Ethinyl Estradiol; Flaxseed OIL; Vitamin D; Minerals NOS



Possible Neupogen side effects in 25 year old female

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

Patient: 25 year old female

Reactions: Neutropenia

Drug(s) suspected as cause:
Neupogen



Possible Neupogen side effects in 56 year old female

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

Patient: 56 year old female

Reactions: Arthralgia

Drug(s) suspected as cause:
Neupogen

Other drugs received by patient: Ciprofloxacin HCL; Rifampin; Etoposide; Zofran



Possible Neupogen side effects in 23 year old female

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

Patient: 23 year old female

Reactions: Pyrexia, Pregnancy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Neupogen



Possible Neupogen side effects in

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

Patient:

Reactions: Expired Drug Administered, Drug Dispensing Error

Drug(s) suspected as cause:
Neupogen



Possible Neupogen side effects in 50 year old male

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

Patient: 50 year old male

Reactions: Injection Site Haemorrhage, Neutropenia

Drug(s) suspected as cause:
Neupogen



Possible Neupogen side effects in 78 year old male

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

Patient: 78 year old male, weighing 99.8 kg (219.5 pounds)

Reactions: Eosinophil Count Increased

Drug(s) suspected as cause:
Aranesp
    Dosage: 200 mg, q2wk
    Indication: Anaemia

Neupogen
    Dosage: 480 mug, unk
    Indication: Neutropenia
    Start date: 2012-07-18

Other drugs received by patient: Vancomycin; Triamterene; Synthroid; Vancomycin; Norco; Cefepime; Questran; Florinef

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