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 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 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 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 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 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 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
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 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 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 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 female
Reported by a consumer/non-health professional from United States on 2012-08-16
Patient: female
Reactions: Hot Flush, Nausea, Hypotension, Dizziness, Discomfort
Drug(s) suspected as cause:
Nplate
Possible Nplate side effects in 45 year old female
Reported by a consumer/non-health professional from United States on 2012-08-16
Patient: 45 year old female
Reactions: Drug Ineffective, Platelet Count Decreased
Drug(s) suspected as cause:
Nplate
Possible Nplate side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-16
Patient: female
Reactions: Platelet Count Decreased, Platelet Count Increased
Drug(s) suspected as cause:
Nplate
Possible Nplate side effects in
Reported by a pharmacist from United States on 2012-08-16
Patient:
Reactions: Platelet Disorder
Drug(s) suspected as cause:
Nplate
Possible Nplate 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 Nplate side effects in male
Reported by a pharmacist from United States on 2012-08-16
Patient: male, weighing 130.0 kg (286.0 pounds)
Reactions: Platelet Disorder
Drug(s) suspected as cause:
Nplate
Possible Nplate side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-16
Patient: female
Reactions: Drug Ineffective
Drug(s) suspected as cause:
Nplate
Other drugs received by patient: Loestrin FE 1 / 20
Possible Nplate side effects in 77 year old male
Reported by a pharmacist from United States on 2012-08-16
Patient: 77 year old male, weighing 95.3 kg (209.7 pounds)
Reactions: Insomnia, Arthritis
Drug(s) suspected as cause:
Nplate
Other drugs received by patient: Simvastatin; Furosemide; Nitro-DUR; Losartan Potassium; Coreg; Tramadol HCL; Fluticasone Propionate; Glucovance
Possible Nplate side effects in 60 year old female
Reported by a physician from United States on 2012-08-16
Patient: 60 year old female
Reactions: Platelet Count Decreased
Drug(s) suspected as cause:
Nplate
Possible Nplate side effects in 14 year old male
Reported by a physician from United States on 2012-08-16
Patient: 14 year old male, weighing 57.1 kg (125.6 pounds)
Reactions: Drug Ineffective
Drug(s) suspected as cause:
Nplate
Other drugs received by patient: Immune Globulin NOS; Multi-Vitamins
Possible Nplate side effects in 66 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-16
Patient: 66 year old male, weighing 103.0 kg (226.6 pounds)
Reactions: Abdominal Pain, Platelet Count Decreased, Headache
Drug(s) suspected as cause:
Nplate
Dosage: 100 mug, qwk
Indication: Idiopathic Thrombocytopenic Purpura
Start date: 2011-04-01
End date: 2011-12-01
Nplate
Dosage: 100 mug, unk
Start date: 2011-12-01
End date: 2012-05-01
Other drugs received by patient: Excedrin (Migraine)
Possible Nplate side effects in 17 year old male
Reported by a physician from United States on 2012-08-16
Patient: 17 year old male, weighing 123.7 kg (272.1 pounds)
Reactions: Abdominal Pain, Vomiting, Nausea, Diarrhoea
Drug(s) suspected as cause:
Nplate
Other drugs received by patient: Omeprazole
Possible Nplate side effects in male
Reported by a pharmacist from United States on 2012-08-16
Patient: male
Reactions: Platelet Disorder
Drug(s) suspected as cause:
Nplate
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