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Nplate Adverse Events Reported to the FDA Over Time

How are Nplate adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Nplate, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Nplate is flagged as the suspect drug causing the adverse event.

Most Common Nplate Adverse Events Reported to the FDA

What are the most common Nplate adverse events reported to the FDA?

Drug Ineffective
2105 (5.82%)
Therapeutic Response Decreased
1870 (5.17%)
Thrombocytopenia
1324 (3.66%)
Death
1278 (3.53%)
Platelet Count Decreased
1236 (3.42%)
Myelodysplastic Syndrome
584 (1.62%)
Fatigue
380 (1.05%)
Headache
372 (1.03%)
Hospitalisation
354 (.98%)
Deep Vein Thrombosis
348 (.96%)
Pneumonia
344 (.95%)
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Platelet Count Increased
330 (.91%)
Platelet Count Abnormal
317 (.88%)
Anaemia
305 (.84%)
Haemorrhage
303 (.84%)
Asthenia
294 (.81%)
Arthralgia
288 (.8%)
Epistaxis
266 (.74%)
Oedema Peripheral
260 (.72%)
Sepsis
256 (.71%)
Contusion
252 (.7%)
Pulmonary Embolism
244 (.67%)
Biopsy Bone Marrow Abnormal
240 (.66%)
Petechiae
239 (.66%)
Thrombosis
235 (.65%)
Nausea
229 (.63%)
Acute Myeloid Leukaemia
226 (.63%)
Pain In Extremity
197 (.54%)
Idiopathic Thrombocytopenic Purpura
194 (.54%)
Haematological Malignancy
188 (.52%)
Dizziness
187 (.52%)
Cerebrovascular Accident
185 (.51%)
Pyrexia
185 (.51%)
Gastrointestinal Haemorrhage
178 (.49%)
Myalgia
169 (.47%)
Dyspnoea
168 (.46%)
Respiratory Failure
161 (.45%)
Chronic Lymphocytic Leukaemia
159 (.44%)
Pancytopenia
159 (.44%)
Pain
155 (.43%)
Cardiac Failure Congestive
153 (.42%)
Malaise
153 (.42%)
Fall
149 (.41%)
Pleural Effusion
149 (.41%)
Renal Failure
146 (.4%)
Diarrhoea
145 (.4%)
Abdominal Pain
144 (.4%)
Haemoglobin Decreased
144 (.4%)
Purpura
144 (.4%)
Bone Marrow Disorder
138 (.38%)
Rash
133 (.37%)
Renal Failure Acute
132 (.37%)
Leukocytosis
124 (.34%)
Splenectomy
124 (.34%)
Disease Progression
122 (.34%)
Weight Decreased
119 (.33%)
Neoplasm Malignant
117 (.32%)
Back Pain
115 (.32%)
Lymphoma
115 (.32%)
Hypotension
112 (.31%)
Rectal Haemorrhage
109 (.3%)
Vaginal Haemorrhage
109 (.3%)
Embolism
106 (.29%)
General Physical Health Deteriorati...
106 (.29%)
Ecchymosis
105 (.29%)
Insomnia
105 (.29%)
Splenomegaly
105 (.29%)
Bone Pain
97 (.27%)
Cardiac Arrest
96 (.27%)
Paraesthesia
96 (.27%)
Pruritus
95 (.26%)
Rash Erythematous
95 (.26%)
Rash Maculo-papular
95 (.26%)
White Blood Cell Count Increased
92 (.25%)
Atrial Fibrillation
91 (.25%)
Chills
91 (.25%)
Gingival Bleeding
91 (.25%)
Myelofibrosis
90 (.25%)
Melaena
89 (.25%)
Multiple Myeloma
88 (.24%)
Infection
85 (.24%)
Chest Pain
84 (.23%)
Chronic Obstructive Pulmonary Disea...
83 (.23%)
Decreased Appetite
83 (.23%)
Lung Neoplasm Malignant
83 (.23%)
Musculoskeletal Pain
82 (.23%)
Myocardial Infarction
80 (.22%)
Hepatic Cirrhosis
78 (.22%)
Hypoaesthesia
77 (.21%)
Urinary Tract Infection
77 (.21%)
Cardiac Disorder
76 (.21%)
Haemorrhage Intracranial
76 (.21%)
Hypertension
74 (.2%)
Mouth Haemorrhage
74 (.2%)
Vomiting
74 (.2%)
Aplastic Anaemia
73 (.2%)
Muscular Weakness
73 (.2%)
Haematuria
71 (.2%)
Constipation
70 (.19%)
Cough
68 (.19%)
Lymphadenopathy
66 (.18%)

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This graph shows the top adverse events submitted to the FDA for Nplate, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Nplate is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Nplate

What are the most common Nplate adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Nplate, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Nplate is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Nplate According to Those Reporting Adverse Events

Why are people taking Nplate, according to those reporting adverse events to the FDA?

Idiopathic Thrombocytopenic Purpura
8742
Product Used For Unknown Indication
733
Thrombocytopenia
607
Drug Use For Unknown Indication
204
Myelodysplastic Syndrome
143
Autoimmune Thrombocytopenia
58
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Chronic Lymphocytic Leukaemia
28
Thrombocytopenic Purpura
22
Platelet Count Decreased
21
Evans Syndrome
21
Aplastic Anaemia
16
Pancytopenia
9
Pre-existing Disease
8
Autoimmune Disorder
8
Off Label Use
8
Multiple Myeloma
7
Waldenstroms Macroglobulinaemia
7
Non-hodgkins Lymphoma
6
Large Granular Lymphocytosis
5
Surgery
5
Anaemia
5
Lymphoma
5
Glioblastoma Multiforme
4
Myelofibrosis
4
Wiskott-aldrich Syndrome
4
Thrombocytosis
3
Eosinophilia
3
Graft Versus Host Disease
3
Ovarian Cancer
3
Purpura
3
Bile Duct Cancer
3
Megakaryocytes
3
Rectal Cancer Metastatic
2
Haematology Test Abnormal
2
Bone Marrow Transplant
1
Haemorrhagic Diathesis
1
Squamous Cell Carcinoma
1
Lung Neoplasm Malignant
1
Systemic Lupus Erythematosus
1
Haemorrhage
1
Hepatic Cirrhosis
1
Thrombotic Thrombocytopenic Purpura
1
Metastatic Gastric Cancer
1
Choroid Melanoma
1
Acute Myeloid Leukaemia
1
Prostate Cancer
1
Chronic Lymphocytic Leukaemia Stage...
1
Chronic Myeloid Leukaemia
1
Neurilemmoma Malignant
1
Ecchymosis
1
Idiopathic Pneumonia Syndrome
1

Drug Labels

LabelLabelerEffective
NplateAmgen Inc06-NOV-12

Nplate Case Reports

What Nplate safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Nplate. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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