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Nplate (Romiplostim Subcutaneous) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Nplate (Romiplostim Subcutaneous) 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 (1906)
Death (469)
Life Threatening Events (28)
Disability (15)

Reports by Reaction Type

Therapeutic Response Decreased (281)Platelet Count Decreased (260)Drug Ineffective (247)Thrombocytopenia (168)Death (155)Haemorrhage (105)Hospitalisation (92)Haemoglobin Decreased (84)Rectal Haemorrhage (78)Vaginal Haemorrhage (78)Purpura (77)Myelodysplastic Syndrome (75)

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

Possible Nplate side effects in 49 year old male

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

Patient: 49 year old male, weighing 74.0 kg (162.8 pounds)

Reactions: Therapeutic Response Decreased, Surgery, Post Procedural Complication, Bronchitis, Nosocomial Infection, Preoperative Care

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Nplate
    Dosage: 2 mug/kg, qwk

Nplate
    Dosage: 7 mug/kg, qwk

Nplate
    Dosage: 1 mug/kg, qwk
    Indication: Idiopathic Thrombocytopenic Purpura

Other drugs received by patient: Kanakion; Folic Acid; Selenium ACE



Possible Nplate side effects in 12 year old male

Reported by a pharmacist from United States on 2012-08-27

Patient: 12 year old male, weighing 95.9 kg (211.0 pounds)

Reactions: Rhinovirus Infection, Graft Versus Host Disease, Tinea Cruris, Pyrexia, Transaminases Increased, Odynophagia, Hypokalaemia, Gastritis, Hyperlipidaemia, Osteonecrosis, Metapneumovirus Infection, Diarrhoea, Hypomagnesaemia, Staphylococcal Bacteraemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Nplate

Nplate

Nplate

Nplate
    Dosage: 485 mug, qwk
    Indication: Idiopathic Thrombocytopenic Purpura
    Start date: 2011-02-01

Nplate

Nplate

Nplate

Other drugs received by patient: Calcium + Vitamin D; Lovaza; Magnesium / 00430401 /; EYE Drops; Cholecalciferol; Prednisone TAB; Prilosec; Micafungin; Cellcept; Acyclovir; Penicillin; Permanganate Potassium; Multivitamin / 00097801 /



Possible Nplate side effects in 66 year old male

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

Patient: 66 year old male

Reactions: Back Pain, Pain in Extremity, Platelet Count Decreased, Gait Disturbance, Asthenia, Idiopathic Thrombocytopenic Purpura, Muscle Spasms

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Nplate

Other drugs received by patient: Glucophage; Insulin; Zantac; Cortisone Acetate; Acyclovir



Possible Nplate side effects in 14 year old female

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

Patient: 14 year old female, weighing 99.6 kg (219.1 pounds)

Reactions: Abdominal Pain, Viral Infection, Body Temperature Increased, Nausea, Blood Lactate Dehydrogenase Increased, Underdose, Purpura, Pyrexia, Haemolysis, RED Blood Cell Morphology Abnormal, Therapeutic Response Decreased, Injection Site Extravasation, Poor Venous Access, Blood Smear Test Abnormal, Menorrhagia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Nplate
    Dosage: 300 mug, qwk
    Start date: 2011-02-07
    End date: 2011-02-17

Nplate
    Dosage: 600 mug, qwk
    Start date: 2011-03-10
    End date: 2011-03-17

Nplate
    Dosage: 100 mug, qwk
    Indication: Idiopathic Thrombocytopenic Purpura
    Start date: 2010-12-14
    End date: 2010-12-28

Nplate
    Dosage: 250 mug, qwk
    Start date: 2011-01-31
    End date: 2011-02-07

Nplate
    Dosage: 500 mug, qwk
    Start date: 2011-03-02
    End date: 2011-03-02

Nplate
    Dosage: 200 mug, qwk
    Start date: 2010-12-28
    End date: 2011-01-04

Nplate
    Dosage: 200 mug, qwk
    Start date: 2011-01-24
    End date: 2011-01-31

Nplate
    Dosage: 400 mug, qwk
    Start date: 2011-02-17
    End date: 2011-02-17

Other drugs received by patient: Prednisone TAB; Prednisone TAB; Prednisone TAB; Prednisone TAB; Dexamethasone; Prednisone TAB



Possible Nplate side effects in 12 year old male

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

Patient: 12 year old male, weighing 95.9 kg (211.0 pounds)

Reactions: Graft Versus Host Disease, Rhinovirus Infection, Tinea Cruris, Pyrexia, Transaminases Increased, Odynophagia, Gastritis, Hypokalaemia, Hyperlipidaemia, Osteonecrosis, Diarrhoea, Metapneumovirus Infection, Hypomagnesaemia, Staphylococcal Bacteraemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Nplate

Nplate
    Dosage: 485 mug, qwk
    Indication: Idiopathic Thrombocytopenic Purpura
    Start date: 2011-02-01

Nplate

Nplate

Nplate

Nplate

Nplate

Other drugs received by patient: Multivitamin / 00097801 /; Prilosec; Prednisone TAB; Penicillin; Calcium + Vitamin D; Magnesium / 00430401 /; Lovaza; EYE Drops; Micafungin; Permanganate Potassium; Cellcept; Acyclovir; Cholecalciferol



Possible Nplate side effects in 80 year old male

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

Patient: 80 year old male

Reactions: Anti-Platelet Antibody Negative, Platelet Count Decreased, Splenomegaly

Drug(s) suspected as cause:
Nplate

Other drugs received by patient: Prednisone TAB



Possible Nplate side effects in 62 year old male

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

Patient: 62 year old male, weighing 91.1 kg (200.4 pounds)

Reactions: Therapeutic Response Decreased, Arthralgia, Treatment Failure

Drug(s) suspected as cause:
Nplate
    Dosage: 10 mug, qwk
    Indication: Autoimmune Thrombocytopenia
    Start date: 2011-11-28
    End date: 2012-07-19

Nplate
    Dosage: 9 mug/kg, unk

Other drugs received by patient: Losartan Potassium



Possible Nplate side effects in

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

Patient:

Reactions: Drug Specific Antibody Present

Drug(s) suspected as cause:
Nplate



Possible Nplate side effects in female

Reported by a physician from United Kingdom on 2012-08-22

Patient: female

Reactions: Therapeutic Response Decreased

Drug(s) suspected as cause:
Nplate



Possible Nplate side effects in 32 year old female

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

Patient: 32 year old female

Reactions: Weight Increased, Myalgia, Hospitalisation, Activities of Daily Living Impaired, Arthralgia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Nplate

Other drugs received by patient: Corticosteroids



Possible Nplate side effects in 66 year old male

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

Patient: 66 year old male

Reactions: Medication Error

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Nplate



Possible Nplate side effects in 82 year old female

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: 82 year old female, weighing 41.4 kg (91.0 pounds)

Reactions: Therapeutic Response Decreased, Thrombocytopenia

Drug(s) suspected as cause:
Nplate
    Dosage: 4 mug/kg, qwk
    Indication: Idiopathic Thrombocytopenic Purpura
    Start date: 2011-11-15

Nplate
    Dosage: 168 mug, qwk
    End date: 2012-08-07

Other drugs received by patient: Imdur; Nexium; Magnesium Oxide; Iviglob-EX; Iviglob-EX; Boniva; Aspirin; Vitamin D; Calcium Carbonate; Rituxan; Metoprolol Tartrate; Rituxan; Rituxan; Rituxan; Iviglob-EX; Capoten; Lipitor; Rituxan; Iviglob-EX



Possible Nplate side effects in male

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

Patient: male, weighing 100.0 kg (220.0 pounds)

Reactions: Therapeutic Response Decreased

Drug(s) suspected as cause:
Nplate

Other drugs received by patient: NEO-Mercazole TAB



Possible Nplate side effects in female

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

Patient: female

Reactions: Cerebrovascular Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Nplate
    Indication: Idiopathic Thrombocytopenic Purpura

Revolade
    Administration route: Oral
    Indication: Idiopathic Thrombocytopenic Purpura



Possible Nplate side effects in 52 year old male

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

Patient: 52 year old male

Reactions: Therapeutic Response Decreased

Drug(s) suspected as cause:
Nplate



Possible Nplate side effects in 57 year old female

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

Patient: 57 year old female

Reactions: Haemorrhage, Platelet Count Decreased

Drug(s) suspected as cause:
Nplate



Possible Nplate side effects in female

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

Patient: female

Reactions: Chronic Myeloid Leukaemia

Drug(s) suspected as cause:
Nplate

Other drugs received by patient: Herceptin



Possible Nplate side effects in 24 year old male

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

Patient: 24 year old male

Reactions: Capillary Disorder, Petechiae

Drug(s) suspected as cause:
Nplate



Possible Nplate side effects in 53 year old female

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

Patient: 53 year old female

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Nplate



Possible Nplate side effects in

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

Patient:

Reactions: Raynaud's Phenomenon

Drug(s) suspected as cause:
Nplate



Possible Nplate side effects in female

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

Patient: female

Reactions: Dizziness, Headache

Drug(s) suspected as cause:
Nplate



Possible Nplate side effects in 76 year old male

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

Patient: 76 year old male

Reactions: Platelet Count Decreased

Drug(s) suspected as cause:
Nplate



Possible Nplate side effects in male

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

Patient: male

Reactions: Restlessness, Insomnia

Drug(s) suspected as cause:
Nplate



Possible Nplate side effects in female

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

Patient: female

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Nplate



Possible Nplate side effects in male

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

Patient: male

Reactions: Headache

Drug(s) suspected as cause:
Nplate



Possible Nplate side effects in

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

Patient:

Reactions: Inappropriate Schedule of Drug Administration

Drug(s) suspected as cause:
Nplate



Possible Nplate side effects in 78 year old female

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

Patient: 78 year old female, weighing 50.8 kg (111.7 pounds)

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Nplate



Possible Nplate side effects in 29 year old female

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

Patient: 29 year old female

Reactions: Headache

Drug(s) suspected as cause:
Nplate



Possible Nplate side effects in 62 year old male

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

Patient: 62 year old male

Reactions: Diarrhoea, Urticaria, Headache, Muscle Spasms

Drug(s) suspected as cause:
Nplate
    Dosage: unk
    Indication: Idiopathic Thrombocytopenic Purpura
    Start date: 2008-01-01

Nplate
    Dosage: unk, qwk
    Start date: 2012-01-01
    End date: 2012-06-19



Possible Nplate side effects in female

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

Patient: female

Reactions: Platelet Count Increased

Drug(s) suspected as cause:
Nplate

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