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Revlimid Adverse Events Reported to the FDA Over Time

How are Revlimid adverse event reports trending over time?

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

Most Common Revlimid Adverse Events Reported to the FDA

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

Death
8623 (6.29%)
Multiple Myeloma
4656 (3.4%)
Pneumonia
3293 (2.4%)
Fatigue
2220 (1.62%)
Thrombocytopenia
2061 (1.5%)
Anaemia
2037 (1.49%)
Platelet Count Decreased
2037 (1.49%)
Neutropenia
2025 (1.48%)
Disease Progression
1913 (1.4%)
Diarrhoea
1904 (1.39%)
Pancytopenia
1836 (1.34%)
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Sepsis
1654 (1.21%)
Renal Failure
1454 (1.06%)
Asthenia
1451 (1.06%)
Pyrexia
1417 (1.03%)
White Blood Cell Count Decreased
1412 (1.03%)
Rash
1363 (.99%)
Dyspnoea
1229 (.9%)
Haemoglobin Decreased
1220 (.89%)
Dehydration
1002 (.73%)
Nausea
976 (.71%)
Myelodysplastic Syndrome
970 (.71%)
Renal Failure Acute
956 (.7%)
Deep Vein Thrombosis
951 (.69%)
Neuropathy Peripheral
951 (.69%)
Oedema Peripheral
928 (.68%)
Infection
884 (.65%)
Constipation
858 (.63%)
Cardiac Failure Congestive
822 (.6%)
Fall
817 (.6%)
Atrial Fibrillation
770 (.56%)
Neutrophil Count Decreased
770 (.56%)
Pulmonary Embolism
767 (.56%)
Dizziness
729 (.53%)
Hypotension
712 (.52%)
Febrile Neutropenia
710 (.52%)
Thrombosis
667 (.49%)
Acute Myeloid Leukaemia
639 (.47%)
Malignant Neoplasm Progression
625 (.46%)
Respiratory Failure
609 (.44%)
Pruritus
585 (.43%)
Vomiting
571 (.42%)
Decreased Appetite
566 (.41%)
Muscle Spasms
566 (.41%)
Malaise
563 (.41%)
Neoplasm Progression
560 (.41%)
Pain
552 (.4%)
Back Pain
548 (.4%)
Urinary Tract Infection
541 (.39%)
Drug Ineffective
530 (.39%)
Myocardial Infarction
530 (.39%)
Full Blood Count Decreased
529 (.39%)
Cardiac Disorder
514 (.38%)
Haemorrhage
494 (.36%)
Septic Shock
486 (.35%)
Confusional State
482 (.35%)
General Physical Health Deteriorati...
461 (.34%)
Cardiac Failure
447 (.33%)
Cerebrovascular Accident
446 (.33%)
Weight Decreased
443 (.32%)
Blood Creatinine Increased
418 (.31%)
Red Blood Cell Count Decreased
374 (.27%)
Blood Count Abnormal
373 (.27%)
Leukopenia
371 (.27%)
Pleural Effusion
371 (.27%)
Blood Human Chorionic Gonadotropin ...
358 (.26%)
Renal Impairment
351 (.26%)
Pain In Extremity
341 (.25%)
Headache
340 (.25%)
Chest Pain
339 (.25%)
Cough
339 (.25%)
Cardiac Arrest
338 (.25%)
Renal Disorder
336 (.25%)
Multi-organ Failure
335 (.24%)
Syncope
330 (.24%)
Bronchitis
324 (.24%)
Hypoaesthesia
323 (.24%)
Cellulitis
319 (.23%)
Hypokalaemia
318 (.23%)
Gastrointestinal Haemorrhage
314 (.23%)
Abdominal Pain
308 (.22%)
No Therapeutic Response
307 (.22%)
Arthralgia
305 (.22%)
Hypercalcaemia
297 (.22%)
Arrhythmia
277 (.2%)
Convulsion
276 (.2%)
Epistaxis
267 (.19%)
Hyponatraemia
262 (.19%)
Bone Marrow Failure
260 (.19%)
Insomnia
260 (.19%)
Contusion
257 (.19%)
Tremor
256 (.19%)
Condition Aggravated
245 (.18%)
Myelodysplastic Syndrome Transforma...
240 (.18%)
Joint Swelling
237 (.17%)
Paraesthesia
235 (.17%)
Hyperglycaemia
233 (.17%)
Cataract
228 (.17%)
Chronic Obstructive Pulmonary Disea...
220 (.16%)
Mental Status Changes
218 (.16%)
Pulmonary Oedema
216 (.16%)

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

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

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

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

Multiple Myeloma
26146
Myelodysplastic Syndrome
4491
Lymphoma
523
Drug Use For Unknown Indication
473
Myelofibrosis
410
Amyloidosis
400
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Chronic Lymphocytic Leukaemia
292
Non-hodgkins Lymphoma
234
Mantle Cell Lymphoma
177
Acute Myeloid Leukaemia
154
Plasmacytoma
134
Prostate Cancer
134
Myeloma Recurrence
129
Product Used For Unknown Indication
125
Diffuse Large B-cell Lymphoma
102
B-cell Lymphoma
95
5q Minus Syndrome
74
Lymphoproliferative Disorder
54
5q-syndrome
53
Hodgkins Disease
46
Refractory Cancer
39
Anaemia
34
Lymphatic Disorder
34
Neoplasm
31
Waldenstroms Macroglobulinaemia
29
Leukaemia Plasmacytic
27
Myeloproliferative Disorder
26
Ovarian Cancer
21
Cytogenetic Abnormality
20
Lymphocytic Leukaemia
17
Chronic Myeloid Leukaemia
17
T-cell Lymphoma
17
Paraproteinaemia
16
Poems Syndrome
15
Monoclonal Gammopathy
15
Cytogenetic Analysis Abnormal
15
Refractory Anaemia
14
Thyroid Cancer
14
Pancytopenia
13
Prostate Cancer Metastatic
13
Myeloid Leukaemia
12
Glioblastoma
12
Polycythaemia Vera
12
Leukaemia
12
Chronic Myelomonocytic Leukaemia
11
Disease Progression
10
Chemotherapy
10
Neoplasm Malignant
9
Lymphatic System Neoplasm
9
Kaposis Sarcoma
9
Non-hodgkins Lymphoma Refractory
9

Drug Labels

LabelLabelerEffective
RevlimidCelgene Corporation18-FEB-13

Revlimid Case Reports

What Revlimid 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 Revlimid. 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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