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Lenalidomide Adverse Events Reported to the FDA Over Time

How are Lenalidomide adverse event reports trending over time?

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

Most Common Lenalidomide Adverse Events Reported to the FDA

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

Pneumonia
356 (2.42%)
Thrombocytopenia
277 (1.88%)
Neutropenia
269 (1.83%)
Anaemia
220 (1.5%)
Pyrexia
200 (1.36%)
Sepsis
197 (1.34%)
General Physical Health Deteriorati...
181 (1.23%)
Haemoglobin Decreased
181 (1.23%)
Multiple Myeloma
170 (1.16%)
Platelet Count Decreased
165 (1.12%)
Disease Progression
157 (1.07%)
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Pulmonary Embolism
156 (1.06%)
Dyspnoea
155 (1.05%)
Febrile Neutropenia
143 (.97%)
Renal Failure Acute
143 (.97%)
Dehydration
136 (.92%)
Fatigue
134 (.91%)
Asthenia
121 (.82%)
Atrial Fibrillation
116 (.79%)
Diarrhoea
116 (.79%)
Death
114 (.78%)
Pancytopenia
114 (.78%)
Acute Myeloid Leukaemia
106 (.72%)
White Blood Cell Count Decreased
103 (.7%)
Hypotension
102 (.69%)
Renal Failure
100 (.68%)
Respiratory Failure
98 (.67%)
Deep Vein Thrombosis
97 (.66%)
Confusional State
92 (.63%)
Septic Shock
85 (.58%)
Myelodysplastic Syndrome
84 (.57%)
Pleural Effusion
83 (.56%)
Infection
80 (.54%)
Nausea
80 (.54%)
Malignant Neoplasm Progression
79 (.54%)
Vomiting
78 (.53%)
Blood Creatinine Increased
76 (.52%)
Hypercalcaemia
75 (.51%)
Pain
72 (.49%)
Back Pain
69 (.47%)
Rash
68 (.46%)
Fall
64 (.44%)
Squamous Cell Carcinoma Of Skin
61 (.41%)
Multi-organ Failure
60 (.41%)
Oedema Peripheral
58 (.39%)
Basal Cell Carcinoma
55 (.37%)
Neutrophil Count Decreased
55 (.37%)
Syncope
54 (.37%)
Condition Aggravated
53 (.36%)
Leukopenia
53 (.36%)
Abdominal Pain
52 (.35%)
Constipation
52 (.35%)
Hypocalcaemia
52 (.35%)
Cough
51 (.35%)
Haematocrit Decreased
51 (.35%)
Alanine Aminotransferase Increased
50 (.34%)
Prostate Cancer
50 (.34%)
Cardiac Arrest
47 (.32%)
Decreased Appetite
47 (.32%)
Lung Disorder
47 (.32%)
Tumour Lysis Syndrome
47 (.32%)
Hypokalaemia
46 (.31%)
No Therapeutic Response
46 (.31%)
Hyponatraemia
45 (.31%)
Lower Respiratory Tract Infection
45 (.31%)
Neuropathy Peripheral
45 (.31%)
Lung Infection
41 (.28%)
Tumour Flare
41 (.28%)
Atelectasis
40 (.27%)
Bronchopneumonia
40 (.27%)
Hyperglycaemia
39 (.27%)
Urinary Tract Infection
39 (.27%)
Blood Calcium Decreased
38 (.26%)
Dizziness
38 (.26%)
Renal Failure Chronic
38 (.26%)
Somnolence
37 (.25%)
Weight Decreased
37 (.25%)
Bone Pain
36 (.24%)
Myocardial Infarction
35 (.24%)
Pulmonary Oedema
35 (.24%)
Acute Respiratory Distress Syndrome
34 (.23%)
Cardiac Failure
34 (.23%)
Chest Pain
34 (.23%)
Haemorrhage
34 (.23%)
Loss Of Consciousness
34 (.23%)
Aspartate Aminotransferase Increase...
33 (.22%)
Cardiac Failure Congestive
33 (.22%)
Malaise
33 (.22%)
Renal Impairment
33 (.22%)
Respiratory Tract Infection
33 (.22%)
Blood Urea Increased
32 (.22%)
Herpes Zoster
32 (.22%)
Hypoxia
32 (.22%)
Red Blood Cell Count Decreased
32 (.22%)
Convulsion
31 (.21%)
Thrombosis
31 (.21%)
Breast Cancer
30 (.2%)
Cerebrovascular Accident
30 (.2%)
Blood Potassium Decreased
29 (.2%)
Staphylococcal Infection
28 (.19%)
Blood Lactate Dehydrogenase Increas...
27 (.18%)

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

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

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

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

Multiple Myeloma
1980
Myelodysplastic Syndrome
177
Prostate Cancer
146
Chronic Lymphocytic Leukaemia
120
Mantle Cell Lymphoma
90
Non-hodgkins Lymphoma
80
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Hodgkins Disease
69
B-cell Lymphoma
51
5q-syndrome
41
Acute Myeloid Leukaemia
27
Lymphoma
26
Diffuse Large B-cell Lymphoma
25
Amyloidosis
23
Myeloma Recurrence
21
Drug Use For Unknown Indication
18
Complex Regional Pain Syndrome
18
Product Used For Unknown Indication
16
Hepatic Neoplasm Malignant
12
Myelofibrosis
12
Primary Amyloidosis
11
Glioblastoma Multiforme
10
Glioblastoma
7
T-cell Lymphoma
7
Prostate Cancer Metastatic
5
Stem Cell Transplant
5
Mantle Cell Lymphoma Refractory
4
Non-small Cell Lung Cancer
4
B-cell Lymphoma Refractory
4
Waldenstroms Macroglobulinaemia
4
Colon Cancer Metastatic
4
Peripheral T-cell Lymphoma Unspecif...
4
5q Minus Syndrome
3
Leukaemia Plasmacytic
3
B-cell Small Lymphocytic Lymphoma
3
Metastatic Malignant Melanoma
2
Ovarian Cancer
2
Paraproteinaemia
2
Neoplasm
2
Autism
2
Neoplasm Malignant
2
Light Chain Disease
2
Lymphoproliferative Disorder
2
Bone Sarcoma
2
Dialysis
2
Haematological Malignancy
2
Pancytopenia
1
Lymphocytic Leukaemia
1
Salivary Gland Cancer
1
Pancreatic Carcinoma Metastatic
1
Colorectal Cancer
1
Systemic Lupus Erythematosus
1

Drug Labels

LabelLabelerEffective
RevlimidCelgene Corporation18-FEB-13

Lenalidomide Case Reports

What Lenalidomide 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 Lenalidomide. 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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