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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.

DACLIZUMAB: 2,801 Adverse Event Reports & Safety Profile

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2,801
Total FAERS Reports
193 (6.9%)
Deaths Reported
835
Hospitalizations
2,801
As Primary/Secondary Suspect
226
Life-Threatening
17
Disabilities
Prescription
Status

FDA Application: 761029 ·

First Report: 2001 · Latest Report: 20201201

What Are the Most Common DACLIZUMAB Side Effects?

#1 Most Reported
Alopecia
450 reports (16.1%)
#2 Most Reported
Transplant dysfunction
421 reports (15.0%)
#3 Most Reported
Transplant rejection
385 reports (13.7%)

All DACLIZUMAB Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Alopecia 450 16.1% 0 21
Transplant dysfunction 421 15.0% 3 8
Transplant rejection 385 13.8% 3 8
Acne 382 13.6% 0 4
Ovarian cyst 374 13.4% 0 2
Multiple sclerosis relapse 313 11.2% 6 230
Drug ineffective 229 8.2% 19 28
Pain 224 8.0% 1 20
Pneumonia 213 7.6% 9 31
Condition aggravated 172 6.1% 4 11
Liver function test abnormal 159 5.7% 0 6
Rheumatoid arthritis 159 5.7% 0 3
Sleep disorder due to general medical condition, insomnia type 146 5.2% 0 2
Fatigue 134 4.8% 0 36
Memory impairment 107 3.8% 0 11
Multiple sclerosis 89 3.2% 6 33
Product use issue 87 3.1% 4 3
Fall 86 3.1% 0 38
Rash 85 3.0% 5 20
Overdose 84 3.0% 0 7

Who Reports DACLIZUMAB Side Effects? Age & Gender Data

Gender: 81.5% female, 18.5% male. Average age: 45.7 years. Most reports from: US. View detailed demographics →

Is DACLIZUMAB Getting Safer? Reports by Year

YearReportsDeathsHosp.
2001 2 2 0
2003 9 0 9
2004 13 1 13
2005 1 0 0
2007 1 0 1
2008 1 1 1
2009 2 0 0
2010 4 0 2
2011 4 0 0
2013 11 0 8
2014 9 0 4
2015 13 0 10
2016 162 3 90
2017 728 24 414
2018 208 16 82
2019 6 1 3
2020 6 0 3

View full timeline →

What Is DACLIZUMAB Used For?

IndicationReports
Multiple sclerosis 1,328
Relapsing-remitting multiple sclerosis 560
Product used for unknown indication 441
Transplant 143
Prophylaxis against transplant rejection 98
Immunosuppressant drug therapy 92
Immunosuppression 60
Renal transplant 50
Graft versus host disease 15
Birdshot chorioretinopathy 9

DACLIZUMAB vs Alternatives: Which Is Safer?

DACLIZUMAB vs DACOMITINIB DACLIZUMAB vs DACTINOMYCIN DACLIZUMAB vs DALBAVANCIN DACLIZUMAB vs DALFAMPRIDINE DACLIZUMAB vs DALTEPARIN DACLIZUMAB vs DAMOCTOCOG ALFA PEGOL DACLIZUMAB vs DANAPAROID DACLIZUMAB vs DANAZOL DACLIZUMAB vs DANICOPAN DACLIZUMAB vs DANTROLENE

Official FDA Label for DACLIZUMAB

Official prescribing information from the FDA-approved drug label.