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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.

LEUCOVORIN\LEUCOVORIN: 3,810 Adverse Event Reports & Safety Profile

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3,810
Total FAERS Reports
549 (14.4%)
Deaths Reported
1,588
Hospitalizations
3,810
As Primary/Secondary Suspect
322
Life-Threatening
41
Disabilities

Active Ingredient: LEUCOVORIN\LEUCOVORIN CALCIUM ·

First Report: 19980301 · Latest Report: 20250824

What Are the Most Common LEUCOVORIN\LEUCOVORIN Side Effects?

#1 Most Reported
Drug ineffective
501 reports (13.1%)
#2 Most Reported
Diarrhoea
441 reports (11.6%)
#3 Most Reported
Off label use
384 reports (10.1%)

All LEUCOVORIN\LEUCOVORIN Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug ineffective 501 13.2% 141 161
Diarrhoea 441 11.6% 34 225
Off label use 384 10.1% 65 159
Neuropathy peripheral 321 8.4% 9 36
Neutropenia 298 7.8% 35 89
Disease progression 290 7.6% 73 62
Febrile neutropenia 264 6.9% 42 203
Nausea 253 6.6% 19 96
Fatigue 225 5.9% 22 69
Thrombocytopenia 192 5.0% 30 52
Pyrexia 179 4.7% 25 136
Anaemia 159 4.2% 38 79
Vomiting 145 3.8% 20 80
Product use in unapproved indication 139 3.7% 19 105
Sepsis 139 3.7% 55 99
Therapy partial responder 128 3.4% 16 23
Rash 118 3.1% 7 25
Polyneuropathy 116 3.0% 6 15
Acute kidney injury 111 2.9% 14 90
Malignant neoplasm progression 102 2.7% 17 27

Who Reports LEUCOVORIN\LEUCOVORIN Side Effects? Age & Gender Data

Gender: 40.7% female, 59.3% male. Average age: 58.6 years. Most reports from: US. View detailed demographics →

Is LEUCOVORIN\LEUCOVORIN Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 3 0 0
2006 2 0 0
2009 1 0 1
2010 5 0 1
2011 7 0 4
2012 7 1 3
2013 6 0 4
2014 13 5 6
2015 16 5 6
2016 19 3 11
2017 61 7 12
2018 61 11 24
2019 69 10 22
2020 90 7 28
2021 118 17 28
2022 215 40 126
2023 394 53 286
2024 288 18 214
2025 145 9 81

View full timeline →

What Is LEUCOVORIN\LEUCOVORIN Used For?

IndicationReports
Colorectal cancer metastatic 595
Product used for unknown indication 317
Colorectal cancer 278
Oesophageal adenocarcinoma 225
Adenocarcinoma of colon 202
Colon cancer 155
Metastases to liver 152
Adenocarcinoma gastric 145
Pancreatic carcinoma 133
Pancreatic carcinoma metastatic 122

LEUCOVORIN\LEUCOVORIN vs Alternatives: Which Is Safer?

LEUCOVORIN\LEUCOVORIN vs LEUPROLIDE LEUCOVORIN\LEUCOVORIN vs LEVALBUTEROL LEUCOVORIN\LEUCOVORIN vs LEVAMISOLE LEUCOVORIN\LEUCOVORIN vs LEVAQUIN LEUCOVORIN\LEUCOVORIN vs LEVEMIR LEUCOVORIN\LEUCOVORIN vs LEVETIRACETAM LEUCOVORIN\LEUCOVORIN vs LEVOBUNOLOL LEUCOVORIN\LEUCOVORIN vs LEVOBUPIVACAINE LEUCOVORIN\LEUCOVORIN vs LEVOCARNITINE LEUCOVORIN\LEUCOVORIN vs LEVOCETIRIZINE

Official FDA Label for LEUCOVORIN\LEUCOVORIN

Official prescribing information from the FDA-approved drug label.