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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.

MYCOPHENOLATE MOFETIL\MYCOPHENOLATE MOFETIL: 8,849 Adverse Event Reports & Safety Profile

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8,849
Total FAERS Reports
1,135 (12.8%)
Deaths Reported
3,398
Hospitalizations
8,849
As Primary/Secondary Suspect
509
Life-Threatening
144
Disabilities

Active Ingredient: MYCOPHENOLATE MOFETIL\MYCOPHENOLATE MOFETIL HYDROCHLORIDE ·

First Report: 199404 · Latest Report: 20240618

What Are the Most Common MYCOPHENOLATE MOFETIL\MYCOPHENOLATE MOFETIL Side Effects?

#1 Most Reported
Off label use
1,317 reports (14.9%)
#2 Most Reported
Intentional product use issue
605 reports (6.8%)
#3 Most Reported
Diarrhoea
556 reports (6.3%)

All MYCOPHENOLATE MOFETIL\MYCOPHENOLATE MOFETIL Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Off label use 1,317 14.9% 200 345
Intentional product use issue 605 6.8% 87 145
Diarrhoea 556 6.3% 33 299
Drug ineffective 448 5.1% 8 87
Death 433 4.9% 433 30
Pneumonia 352 4.0% 49 175
Malaise 322 3.6% 17 147
Fatigue 297 3.4% 6 92
Dyspnoea 286 3.2% 18 125
Nausea 285 3.2% 11 128
Pyrexia 285 3.2% 20 223
Acute kidney injury 256 2.9% 44 184
Pain 253 2.9% 6 68
Drug intolerance 251 2.8% 2 16
Condition aggravated 247 2.8% 15 62
Vomiting 246 2.8% 5 153
Neutropenia 228 2.6% 35 126
Transplant rejection 226 2.6% 15 74
Headache 219 2.5% 1 97
Rash 214 2.4% 4 32

Who Reports MYCOPHENOLATE MOFETIL\MYCOPHENOLATE MOFETIL Side Effects? Age & Gender Data

Gender: 54.4% female, 45.6% male. Average age: 50.1 years. Most reports from: US. View detailed demographics →

Is MYCOPHENOLATE MOFETIL\MYCOPHENOLATE MOFETIL Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 7 0 2
2001 15 2 11
2002 11 0 5
2003 4 0 3
2004 28 6 17
2005 14 3 3
2006 24 7 14
2007 35 6 21
2008 29 3 8
2009 69 8 29
2010 101 8 37
2011 94 6 41
2012 152 13 74
2013 216 39 100
2014 380 38 229
2015 488 94 300
2016 551 97 283
2017 478 56 265
2018 593 73 294
2019 478 59 256
2020 328 64 159
2021 153 43 80
2024 1 1 0

View full timeline →

What Is MYCOPHENOLATE MOFETIL\MYCOPHENOLATE MOFETIL Used For?

IndicationReports
Product used for unknown indication 2,766
Renal transplant 1,146
Prophylaxis against transplant rejection 954
Immunosuppression 362
Systemic lupus erythematosus 299
Liver transplant 277
Immunosuppressant drug therapy 238
Heart transplant 186
Lupus nephritis 185
Transplant 155

MYCOPHENOLATE MOFETIL\MYCOPHENOLATE MOFETIL vs Alternatives: Which Is Safer?

MYCOPHENOLATE MOFETIL\MYCOPHENOLATE MOFETIL vs MYCOPHENOLIC ACID MYCOPHENOLATE MOFETIL\MYCOPHENOLATE MOFETIL vs MYFORTIC MYCOPHENOLATE MOFETIL\MYCOPHENOLATE MOFETIL vs MYRBETRIQ MYCOPHENOLATE MOFETIL\MYCOPHENOLATE MOFETIL vs NABILONE MYCOPHENOLATE MOFETIL\MYCOPHENOLATE MOFETIL vs NABUMETONE MYCOPHENOLATE MOFETIL\MYCOPHENOLATE MOFETIL vs NADOFARAGENE FIRADENOVEC-VNCG MYCOPHENOLATE MOFETIL\MYCOPHENOLATE MOFETIL vs NADOLOL MYCOPHENOLATE MOFETIL\MYCOPHENOLATE MOFETIL vs NADROPARIN MYCOPHENOLATE MOFETIL\MYCOPHENOLATE MOFETIL vs NAFARELIN MYCOPHENOLATE MOFETIL\MYCOPHENOLATE MOFETIL vs NAFCILLIN

Official FDA Label for MYCOPHENOLATE MOFETIL\MYCOPHENOLATE MOFETIL

Official prescribing information from the FDA-approved drug label.