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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.

CICLOSPORIN: 476 Adverse Event Reports & Safety Profile

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476
Total FAERS Reports
133 (27.9%)
Deaths Reported
121
Hospitalizations
476
As Primary/Secondary Suspect
18
Life-Threatening
1
Disabilities

First Report: 199904 · Latest Report: 20140611

What Are the Most Common CICLOSPORIN Side Effects?

#1 Most Reported
Drug ineffective
74 reports (15.5%)
#2 Most Reported
Foetal exposure during pregnancy
63 reports (13.2%)
#3 Most Reported
Low birth weight baby
57 reports (12.0%)

All CICLOSPORIN Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug ineffective 74 15.6% 24 14
Foetal exposure during pregnancy 63 13.2% 1 3
Low birth weight baby 57 12.0% 1 3
Premature baby 54 11.3% 0 3
Acute graft versus host disease 41 8.6% 21 1
Cytomegalovirus infection 28 5.9% 13 12
Renal impairment 26 5.5% 7 12
Hypertension 24 5.0% 4 8
Pyrexia 23 4.8% 8 17
Blood creatinine increased 22 4.6% 2 10
Blood pressure increased 22 4.6% 3 4
Multi-organ failure 20 4.2% 19 7
Anaemia 18 3.8% 4 6
Angioedema 18 3.8% 0 0
Exposure during pregnancy 18 3.8% 0 5
Foetal growth restriction 18 3.8% 0 1
Premature labour 18 3.8% 0 3
Immunosuppressant drug level increased 17 3.6% 2 6
Acute lymphocytic leukaemia recurrent 16 3.4% 12 0
Autoimmune haemolytic anaemia 16 3.4% 2 0

Who Reports CICLOSPORIN Side Effects? Age & Gender Data

Average age: 39.2 years. Most reports from: JP. View detailed demographics →

Is CICLOSPORIN Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 1 1 1
2002 2 1 1
2003 8 2 6
2004 5 0 5
2005 2 0 1
2006 2 0 2
2007 7 0 1
2008 3 0 0
2009 7 3 7
2010 6 2 2
2011 11 5 6
2012 15 5 7
2013 18 7 7
2014 8 1 7

View full timeline →

What Is CICLOSPORIN Used For?

IndicationReports
Prophylaxis against graft versus host disease 95
Immunosuppression 93
Prophylaxis against transplant rejection 28
Product used for unknown indication 23
Renal transplant 21
Immunosuppressant drug therapy 14
Urticaria chronic 11
Angioedema 10
Aplastic anaemia 10
Graft versus host disease 9

CICLOSPORIN vs Alternatives: Which Is Safer?

CICLOSPORIN vs CIDOFOVIR CICLOSPORIN vs CILASTATIN CICLOSPORIN vs CILASTATIN\IMIPENEM CICLOSPORIN vs CILAZAPRIL ANHYDROUS CICLOSPORIN vs CILGAVIMAB\TIXAGEVIMAB CICLOSPORIN vs CILOSTAZOL CICLOSPORIN vs CILTACABTAGENE AUTOLEUCEL CICLOSPORIN vs CIMETIDINE CICLOSPORIN vs CIMZIA CICLOSPORIN vs CINACALCET

Official FDA Label for CICLOSPORIN

Official prescribing information from the FDA-approved drug label.