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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

REVLIMID: 8,878 Adverse Event Reports & Safety Profile

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8,878
Total FAERS Reports
1,233 (13.9%)
Deaths Reported
3,659
Hospitalizations
8,878
As Primary/Secondary Suspect
331
Life-Threatening
367
Disabilities

First Report: 200103 · Latest Report: 20141225

What Are the Most Common REVLIMID Side Effects?

#1 Most Reported
Pneumonia
652 reports (7.3%)
#2 Most Reported
Plasma cell myeloma
632 reports (7.1%)
#3 Most Reported
Death
565 reports (6.4%)

All REVLIMID Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Pneumonia 652 7.3% 85 589
Plasma cell myeloma 632 7.1% 241 184
Death 565 6.4% 564 51
Diarrhoea 508 5.7% 20 207
Thrombosis 484 5.5% 4 165
Fatigue 448 5.1% 17 149
Platelet count decreased 362 4.1% 9 112
Full blood count decreased 352 4.0% 6 172
Deep vein thrombosis 332 3.7% 6 154
Pancytopenia 319 3.6% 20 91
Rash 310 3.5% 11 88
Anaemia 286 3.2% 28 145
White blood cell count decreased 284 3.2% 4 102
Neutropenia 253 2.9% 33 93
Asthenia 239 2.7% 17 136
Pulmonary embolism 222 2.5% 7 156
Toxicity to various agents 220 2.5% 5 3
Renal failure 218 2.5% 27 121
Pyrexia 211 2.4% 12 168
Haemoglobin decreased 209 2.4% 8 81

Who Reports REVLIMID Side Effects? Age & Gender Data

Average age: 69.5 years. Most reports from: US. View detailed demographics →

Is REVLIMID Getting Safer? Reports by Year

YearReportsDeathsHosp.
2001 1 0 0
2003 1 0 0
2005 1 0 0
2006 2 0 0
2007 14 0 2
2008 34 5 10
2009 35 2 16
2010 101 13 38
2011 429 18 211
2012 1,009 59 458
2013 3,795 276 1,854
2014 1,105 560 427

View full timeline →

What Is REVLIMID Used For?

IndicationReports
Plasma cell myeloma 7,122
Myelodysplastic syndrome 835
Chronic lymphocytic leukaemia 121
Lymphoma 121
Product used for unknown indication 90
Mantle cell lymphoma 76
5q minus syndrome 72
Acute myeloid leukaemia 56
Amyloidosis 56
Myelofibrosis 52

REVLIMID vs Alternatives: Which Is Safer?

REVLIMID vs REVOLADE REVLIMID vs REVUMENIB REVLIMID vs REYATAZ REVLIMID vs REZAFUNGIN REVLIMID vs RIBASPHERE REVLIMID vs RIBAVIRIN REVLIMID vs RIBOCICLIB REVLIMID vs RIBOFLAVIN REVLIMID vs RIBOFLAVIN 5'-PHOSPHATE REVLIMID vs RIBOFLAVIN 5^-PHOSPHATE

Official FDA Label for REVLIMID

Official prescribing information from the FDA-approved drug label.