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MIRCERA

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Mircera Adverse Events Reported to the FDA Over Time

How are Mircera adverse event reports trending over time?

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

Most Common Mircera Adverse Events Reported to the FDA

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

Death
272 (9.35%)
Haemoglobin Decreased
242 (8.32%)
Anaemia
114 (3.92%)
Aplasia Pure Red Cell
87 (2.99%)
Myocardial Infarction
48 (1.65%)
Drug Ineffective
44 (1.51%)
Pneumonia
37 (1.27%)
Hypertension
28 (.96%)
Disease Progression
27 (.93%)
Thrombocytopenia
26 (.89%)
Cardiac Failure
24 (.83%)
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Cerebrovascular Accident
24 (.83%)
Myocardial Ischaemia
24 (.83%)
Sepsis
24 (.83%)
Angina Pectoris
23 (.79%)
Bone Marrow Failure
23 (.79%)
Infection
23 (.79%)
Renal Failure Chronic
23 (.79%)
Cerebral Ischaemia
22 (.76%)
Chronic Myeloid Leukaemia
20 (.69%)
Pleural Effusion
20 (.69%)
Renal Failure
20 (.69%)
Spinal Compression Fracture
20 (.69%)
Hypoglycaemia
19 (.65%)
Hypotension
18 (.62%)
Lethargy
18 (.62%)
Platelet Count Decreased
17 (.58%)
White Blood Cell Count Decreased
17 (.58%)
Diarrhoea
16 (.55%)
Dyspnoea
16 (.55%)
Fall
16 (.55%)
Headache
16 (.55%)
Hypertensive Encephalopathy
16 (.55%)
Lung Infection
16 (.55%)
Rash
16 (.55%)
Septic Shock
16 (.55%)
Anaemia Haemolytic Autoimmune
14 (.48%)
Cardiac Arrest
14 (.48%)
Hypertensive Crisis
14 (.48%)
Oedema Peripheral
14 (.48%)
Transient Ischaemic Attack
14 (.48%)
Aplastic Anaemia
13 (.45%)
Ischaemic Stroke
13 (.45%)
Pancytopenia
13 (.45%)
Peripheral Arterial Occlusive Disea...
13 (.45%)
Abdominal Pain
12 (.41%)
Hypoaesthesia
12 (.41%)
Peripheral Ischaemia
12 (.41%)
Pruritus
12 (.41%)
Thrombosis
12 (.41%)
Carotid Artery Stenosis
11 (.38%)
Gastrointestinal Haemorrhage
11 (.38%)
Haematocrit Decreased
11 (.38%)
Malaise
11 (.38%)
Nausea
11 (.38%)
Acute Myocardial Infarction
10 (.34%)
Arteriovenous Fistula Thrombosis
10 (.34%)
Cerebral Infarction
10 (.34%)
Chest Pain
10 (.34%)
Device Malfunction
10 (.34%)
Dizziness
10 (.34%)
Femoral Artery Occlusion
10 (.34%)
Respiratory Failure
10 (.34%)
Urosepsis
10 (.34%)
Atrial Fibrillation
9 (.31%)
Cerebral Haemorrhage
9 (.31%)
Device Related Infection
9 (.31%)
Haemolysis
9 (.31%)
Loss Of Consciousness
9 (.31%)
Shock
9 (.31%)
Shunt Occlusion
9 (.31%)
Abdominal Pain Upper
8 (.28%)
Blood Pressure Increased
8 (.28%)
Cardiac Tamponade
8 (.28%)
Haemoglobin Abnormal
8 (.28%)
Head Injury
8 (.28%)
Hyperkalaemia
8 (.28%)
Hypoparathyroidism
8 (.28%)
Leg Amputation
8 (.28%)
Lower Respiratory Tract Infection
8 (.28%)
Myelodysplastic Syndrome
8 (.28%)
No Therapeutic Response
8 (.28%)
Pneumonia Mycoplasmal
8 (.28%)
Pyrexia
8 (.28%)
Asthenia
7 (.24%)
Confusional State
7 (.24%)
Convulsion
7 (.24%)
Dehydration
7 (.24%)
Delirium
7 (.24%)
Haemoglobin Increased
7 (.24%)
Haemorrhage
7 (.24%)
Hallucination, Auditory
7 (.24%)
Liver Disorder
7 (.24%)
Memory Impairment
7 (.24%)
Reticulocyte Count Decreased
7 (.24%)
Vomiting
7 (.24%)
Anaphylactic Shock
6 (.21%)
Blood Creatinine Increased
6 (.21%)
Blood Sodium Increased
6 (.21%)
Bronchopneumonia
6 (.21%)
Cardiac Failure Congestive
6 (.21%)

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This graph shows the top adverse events submitted to the FDA for Mircera, 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 Mircera 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 Mircera

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

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This graph shows the top categories of adverse events submitted to the FDA for Mircera, 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 Mircera 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 Mircera According to Those Reporting Adverse Events

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

Nephrogenic Anaemia
368
Product Used For Unknown Indication
330
Anaemia
77
Renal Failure Chronic
43
Drug Use For Unknown Indication
30
Renal Failure
13
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Renal Disorder
4
Anaemia Of Chronic Disease
4
Myelofibrosis
4
Haemoglobin Decreased
2
Nephropathy
2
Glomerulonephropathy
2
Glomerulonephritis
1
Haemoglobin Abnormal
1
Dialysis
1
Diabetic Nephropathy
1

Mircera Case Reports

What Mircera 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 Mircera. 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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