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Nplate Side Effects

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Common Nplate Side Effects


The most commonly reported Nplate side effects (click to view or check a box to report):

Therapeutic Response Decreased (636)
Platelet Count Decreased (542)
Thrombocytopenia (391)
Death (334)
Platelet Count Abnormal (148)
Headache (140)
Myelodysplastic Syndrome (133)
Fatigue (126)
Anaemia (116)
Platelet Count Increased (111)
Epistaxis (109)
Deep Vein Thrombosis (109)
Arthralgia (100)
Contusion (96)
Pneumonia (95)
Hospitalisation (95)
Asthenia (92)
Pulmonary Embolism (92)
Haemorrhage (89)
Bone Marrow Reticulin Fibrosis (83)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Nplate Side Effects Reported to FDA



Nplate Side Effect Report#9995219
Investigation
This is a report of a 42-year-old male patient (weight: NA) from NL, suffering from the following health symptoms/conditions: immune thrombocytopenic purpura, who was treated with Nplate (dosage: 3 Mug/kg, Qwk, start time:
Jul 07, 2011), combined with: NA. and developed a serious reaction and side effect(s): Investigation after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Nplate treatment in male patients, resulting in Investigation side effect. The patient was hospitalized.
Nplate Side Effect Report#9980755
This report suggests a potential Nplate Death side effect(s) that can have serious consequences. A 62-year-old male patient (weight: NA) from CA was diagnosed with the following symptoms/conditions: immune thrombocytopenic purpura and used Nplate (dosage: Unk) starting
Sep 06, 2013. After starting Nplate the patient began experiencing various side effects, including:Additional drugs used concurrently: NA. Although Nplate demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Death, may still occur.
Nplate Side Effect Report#9980629
Spleen Disorder
This Spleen Disorder problem was reported by a health professional from NL. A 69-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: immune thrombocytopenic purpura. On
Jun 14, 2012 this consumer started treatment with Nplate (dosage: 2 Mug/kg, Qwk). The following drugs were being taken at the same time: NA. When using Nplate, the patient experienced the following unwanted symptoms/side effects: Spleen DisorderAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Spleen Disorder, may become evident only after a product is in use by the general population.
Nplate Side Effect Report#9980477
Deep Vein Thrombosis, Pulmonary Embolism
This Deep Vein Thrombosis side effect was reported by a physician from PT. A 29-year-old female patient (weight:NA) experienced the following symptoms/conditions: immune thrombocytopenic purpura.The patient was prescribed Nplate (drug dosage: 320 Mug, Qwk), which was initiated on
Aug 02, 2013. Concurrently used drugs: NA..After starting to take Nplate the consumer reported adverse symptoms, such as: Deep Vein Thrombosis, Pulmonary EmbolismThese side effects may potentially be related to Nplate. The patient was hospitalized.
Nplate Side Effect Report#9980419
Investigation, Platelet Count Decreased, Haematemesis
This is a report of a 59-year-old male patient (weight: NA) from NL, suffering from the following health symptoms/conditions: immune thrombocytopenic purpura, who was treated with Nplate (dosage: 2 Mug/kg, Qwk, start time:
Dec 20, 2012), combined with: NA. and developed a serious reaction and side effect(s): Investigation, Platelet Count Decreased, Haematemesis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Nplate treatment in male patients, resulting in Investigation side effect. The patient was hospitalized.
Nplate Side Effect Report#9980367
Investigation
This report suggests a potential Nplate Investigation side effect(s) that can have serious consequences. A 71-year-old female patient (weight: NA) from NL was diagnosed with the following symptoms/conditions: immune thrombocytopenic purpura and used Nplate (dosage: 1 Mug/kg, Qwk) starting
Jun 27, 2012. After starting Nplate the patient began experiencing various side effects, including: InvestigationAdditional drugs used concurrently: NA.The patient was hospitalized. Although Nplate demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Investigation, may still occur.
Nplate Side Effect Report#9973540
Pulmonary Embolism, Platelet Count Abnormal
This Pulmonary Embolism problem was reported by a consumer or non-health professional from US. A 48-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: immune thrombocytopenic purpura. On
Dec 23, 2013 this consumer started treatment with Nplate (dosage: 1 Mug/kg, Unk). The following drugs were being taken at the same time:
  • Decadron /00016001/ (Unk)
When using Nplate, the patient experienced the following unwanted symptoms/side effects: Pulmonary Embolism, Platelet Count AbnormalThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Pulmonary Embolism, may become evident only after a product is in use by the general population.
Nplate Side Effect Report#9961218
Immune Thrombocytopenic Purpura, Treatment Noncompliance
This Immune Thrombocytopenic Purpura side effect was reported by a physician from US. A 42-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Nplate (drug dosage: Unk), which was initiated on
Sep 09, 2010. Concurrently used drugs:
  • Danazolen
  • Prednisone
.After starting to take Nplate the consumer reported adverse symptoms, such as: Immune Thrombocytopenic Purpura, Treatment NoncomplianceThese side effects may potentially be related to Nplate.
Nplate Side Effect Report#9950970
Investigation
This is a report of a 46-year-old male patient (weight: NA) from NL, suffering from the following health symptoms/conditions: immune thrombocytopenic purpura, who was treated with Nplate (dosage: 2 Mug/kg, Qwk, start time:
Jul 04, 2012), combined with: NA. and developed a serious reaction and side effect(s): Investigation after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Nplate treatment in male patients, resulting in Investigation side effect. The patient was hospitalized.
Nplate Side Effect Report#9950265
Cardiac Disorder, Adverse Event
This report suggests a potential Nplate Cardiac Disorder side effect(s) that can have serious consequences. A 66-year-old female patient (weight: NA) from NL was diagnosed with the following symptoms/conditions: immune thrombocytopenic purpura and used Nplate (dosage: 2 Mug/kg, Qwk) starting
Apr 23, 2012. After starting Nplate the patient began experiencing various side effects, including: Cardiac Disorder, Adverse EventAdditional drugs used concurrently: NA.The patient was hospitalized. Although Nplate demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Cardiac Disorder, may still occur.
Nplate Side Effect Report#9949548
Respiratory Tract Infection
This Respiratory Tract Infection problem was reported by a health professional from NL. A 60-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: immune thrombocytopenic purpura. On NS this consumer started treatment with Nplate (dosage: Unk Unk, Qwk). The following drugs were being taken at the same time: NA. When using Nplate, the patient experienced the following unwanted symptoms/side effects: Respiratory Tract InfectionThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Respiratory Tract Infection, may become evident only after a product is in use by the general population.
Nplate Side Effect Report#9949006
Chronic Lymphocytic Leukaemia, Platelet Disorder
This Chronic Lymphocytic Leukaemia side effect was reported by a consumer or non-health professional from ES. A 79-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Nplate (drug dosage: 7 Mg/kg, Unk), which was initiated on 201311. Concurrently used drugs:
  • Eltrombopag (75 Mg, Unk)
.After starting to take Nplate the consumer reported adverse symptoms, such as: Chronic Lymphocytic Leukaemia, Platelet DisorderThese side effects may potentially be related to Nplate.
Nplate Side Effect Report#9927769
Therapeutic Response Decreased
This is a report of a 36-year-old patient (weight: NA) from RU, suffering from the following health symptoms/conditions: immune thrombocytopenic purpura, who was treated with Nplate (dosage: 7 Mg/kg, Unk, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Therapeutic Response Decreased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Nplate treatment in patients, resulting in Therapeutic Response Decreased side effect.
Nplate Side Effect Report#9924374
Bronchitis, Platelet Count Decreased, Epistaxis, Local Swelling, Feeling Hot, Musculoskeletal Pain, Arthralgia, Pain In Extremity
This report suggests a potential Nplate Bronchitis side effect(s) that can have serious consequences. A 75-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: immune thrombocytopenic purpura and used Nplate (dosage: Unk) starting NS. After starting Nplate the patient began experiencing various side effects, including: Bronchitis, Platelet Count Decreased, Epistaxis, Local Swelling, Feeling Hot, Musculoskeletal Pain, Arthralgia, Pain In ExtremityAdditional drugs used concurrently: NA.The patient was hospitalized. Although Nplate demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Bronchitis, may still occur.
Nplate Side Effect Report#9924371
Gastrointestinal Haemorrhage, Hypertension
This Gastrointestinal Haemorrhage problem was reported by a consumer or non-health professional from US. A 91-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Nplate (dosage: NA). The following drugs were being taken at the same time: NA. When using Nplate, the patient experienced the following unwanted symptoms/side effects: Gastrointestinal Haemorrhage, HypertensionThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Gastrointestinal Haemorrhage, may become evident only after a product is in use by the general population.
Nplate Side Effect Report#9918772
Vaginal Haemorrhage, Overdose
This Vaginal Haemorrhage side effect was reported by a consumer or non-health professional from FR. A 31-year-old female patient (weight:NA) experienced the following symptoms/conditions: immune thrombocytopenic purpura.The patient was prescribed Nplate (drug dosage: 250 Mug, Unk), which was initiated on 2011. Concurrently used drugs: NA..After starting to take Nplate the consumer reported adverse symptoms, such as: Vaginal Haemorrhage, OverdoseThese side effects may potentially be related to Nplate.
Nplate Side Effect Report#9915902
Haemorrhagic Stroke, Therapeutic Response Decreased
This is a report of a 42-year-old female patient (weight: NA) from RU, suffering from the following health symptoms/conditions: immune thrombocytopenic purpura, who was treated with Nplate (dosage: 8 Mg/kg, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Haemorrhagic Stroke, Therapeutic Response Decreased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Nplate treatment in female patients, resulting in Haemorrhagic Stroke side effect.
Nplate Side Effect Report#9915472
Platelet Count Increased, Ligament Rupture, Groin Pain, Herpes Zoster, Neuralgia
This report suggests a potential Nplate Platelet Count Increased side effect(s) that can have serious consequences. A 49-year-old female patient (weight: NA) from CA was diagnosed with the following symptoms/conditions: immune thrombocytopenic purpura and used Nplate (dosage: Unk) starting
Mar 12, 2012. After starting Nplate the patient began experiencing various side effects, including: Platelet Count Increased, Ligament Rupture, Groin Pain, Herpes Zoster, NeuralgiaAdditional drugs used concurrently: NA. Although Nplate demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Platelet Count Increased, may still occur.
Nplate Side Effect Report#9914317
Investigation, Gastric Dilatation, Muscular Weakness, Thrombosis, Pain In Extremity, Platelet Count Abnormal
This Investigation problem was reported by a consumer or non-health professional from US. A 62-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On 201401 this consumer started treatment with Nplate (dosage: Unk). The following drugs were being taken at the same time: NA. When using Nplate, the patient experienced the following unwanted symptoms/side effects: Investigation, Gastric Dilatation, Muscular Weakness, Thrombosis, Pain In Extremity, Platelet Count AbnormalThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Investigation, may become evident only after a product is in use by the general population.
Nplate Side Effect Report#9912344
Pulmonary Fibrosis, C-reactive Protein Increased, White Blood Cell Count Increased, Interstitial Lung Disease
This Pulmonary Fibrosis side effect was reported by a pharmacist from GB. A 82-year-old male patient (weight:NA) experienced the following symptoms/conditions: immune thrombocytopenic purpura.The patient was prescribed Nplate (drug dosage: Unk), which was initiated on
Feb 21, 2012. Concurrently used drugs: NA..After starting to take Nplate the consumer reported adverse symptoms, such as: Pulmonary Fibrosis, C-reactive Protein Increased, White Blood Cell Count Increased, Interstitial Lung DiseaseThese side effects may potentially be related to Nplate.
Nplate Side Effect Report#9910291
Hospitalisation
This is a report of a 68-year-old male patient (weight: NA) from NL, suffering from the following health symptoms/conditions: NA, who was treated with Nplate (dosage: 500 Mug, Qwk, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Hospitalisation after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Nplate treatment in male patients, resulting in Hospitalisation side effect. The patient was hospitalized.
Nplate Side Effect Report#9905507
Platelet Count Decreased, Haematoma
This report suggests a potential Nplate Platelet Count Decreased side effect(s) that can have serious consequences. A 80-year-old female patient (weight: NA) from IL was diagnosed with the following symptoms/conditions: immune thrombocytopenic purpura,diabetes mellitus and used Nplate (dosage: Unk) starting
Mar 29, 2012. After starting Nplate the patient began experiencing various side effects, including: Platelet Count Decreased, HaematomaAdditional drugs used concurrently:
  • Insulin (Unk)
  • Lantus (Unk)
The patient was hospitalized. Although Nplate demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Platelet Count Decreased, may still occur.
Nplate Side Effect Report#9904509
Investigation
This Death problem was reported by a physician from CA. A 74-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: immune thrombocytopenic purpura. On
Mar 18, 2013 this consumer started treatment with Nplate (dosage: Unk). The following drugs were being taken at the same time: NA. When using Nplate, the patient experienced the following unwanted symptoms/side effects: InvestigationThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Death, may become evident only after a product is in use by the general population.
Nplate Side Effect Report#9903713
Therapeutic Response Decreased
This Therapeutic Response Decreased side effect was reported by a physician from FR. A 49-year-old female patient (weight:NA) experienced the following symptoms/conditions: immune thrombocytopenic purpura.The patient was prescribed Nplate (drug dosage: Unk), which was initiated on 201008. Concurrently used drugs: NA..After starting to take Nplate the consumer reported adverse symptoms, such as: Therapeutic Response DecreasedThese side effects may potentially be related to Nplate.
Nplate Side Effect Report#9900273
Haemorrhage, Platelet Count Decreased
This is a report of a 81-year-old male patient (weight: NA) from IL, suffering from the following health symptoms/conditions: immune thrombocytopenic purpura, who was treated with Nplate (dosage: 370 Mug, Unk, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Haemorrhage, Platelet Count Decreased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Nplate treatment in male patients, resulting in Haemorrhage side effect. The patient was hospitalized.


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The appearance of Nplate on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Nplate reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

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    Nplate Safety Alerts, Active Ingredients, Usage Information

    NDC55513-221
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameNplate
    Nameromiplostim
    Dosage FormINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
    RouteSUBCUTANEOUS
    On market since20080825
    LabelerAmgen Inc
    Active Ingredient(s)ROMIPLOSTIM
    Strength(s)250
    Unit(s)ug/.5mL
    Pharma ClassIncreased Megakaryocyte Maturation [PE],Increased Platelet Production [PE],Thrombopoiesis Stimulatin

    More About Nplate

    Side Effects reported to FDA: 3558

    Nplate safety alerts: No

    Reported deaths: 1253

    Reported hospitalizations: 1248

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