Vykouraleucovorin
According to the FDA label: VYKOURA is indicated for: 1.1 Rescue after high-dose methotrexate (MTX) therapy in adult and pediatric patients. 1.2 Reducing the toxicity of: Methotrexate in adult and pediatric patients with impaired methotrexate elimination or Folic acid antagonists or dihydrofolate reductase (DHFR) inhibitors following an overdose in adult and pediatric patients. 1.3 Treatment of megaloblastic anemias due to folic acid deficiency in adult and pediatric patients when oral therapy is not feasible.
18,507 adverse event reports submitted to the FDA (2004–2026)
Top Reported Adverse Events
The most frequently reported events in association with Vykoura in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
Show these terms with plain-language definitions
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Diarrhoea 1,748 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →Nausea 1,342 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Vomiting 1,101 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →Neutropenia 1,067 reports
A low level of neutrophils, a type of white blood cell that fights infection.
Full definition in the glossary →Pyrexia 981 reports
The medical term for fever, meaning a raised body temperature.
Full definition in the glossary → See all drugs reporting this event →Off Label Use 911 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Fatigue 857 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Disease Progression 749 reports
A report that the underlying condition being treated got worse over time. This describes the course of the illness, not necessarily an effect of the drug.
Full definition in the glossary →Drug Ineffective 701 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Dyspnoea 697 reports
Shortness of breath or difficulty breathing. Also spelled dyspnea in American English.
Full definition in the glossary → See all drugs reporting this event →Asthenia 656 reports
Physical weakness or lack of strength.
Full definition in the glossary →Abdominal Pain 643 reports
Pain in the belly or stomach area.
Full definition in the glossary → See all drugs reporting this event →Febrile Neutropenia 629 reports
A fever occurring together with a low level of neutrophils, a type of infection-fighting white blood cell. It is taken seriously because infection is harder to fight when these cells are low.
Full definition in the glossary →Thrombocytopenia 610 reports
A low level of platelets, the blood cells that help with clotting.
Full definition in the glossary →Dehydration 576 reports
A condition where the body does not have enough water.
Full definition in the glossary →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Male | 8,847 |
| Female | 7,333 |
| Unknown | 156 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 599 |
| 18-34 | 662 |
| 35-49 | 1,768 |
| 50-64 | 4,725 |
| 65-74 | 3,502 |
| 75+ | 1,559 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Vykoura. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Hospitalization | 9,033 |
| Other Serious | 8,910 |
| Death | 2,477 |
| Non-Serious | 1,775 |
| Life-Threatening | 1,425 |
| Disability | 406 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Vykoura. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2004 | 942 |
| 2005 | 790 |
| 2006 | 647 |
| 2007 | 764 |
| 2008 | 889 |
| 2009 | 617 |
| 2010 | 456 |
| 2011 | 887 |
| 2012 | 1,251 |
| 2013 | 251 |
| 2014 | 223 |
| 2015 | 192 |
| 2016 | 218 |
| 2017 | 278 |
| 2018 | 409 |
| 2019 | 498 |
| 2020 | 474 |
| 2021 | 883 |
| 2022 | 1,947 |
| 2023 | 1,710 |
| 2024 | 1,852 |
| 2025 | 1,948 |
| 2026 (partial) | 381 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Vykoura
In FDA adverse event reports that mention Vykoura, these medications appeared most often in the same report.
- Oxaliplatin (6,454 reports)
- Bevacizumab (3,603 reports)
- Methotrexate (2,924 reports)
- Irinotecan (1,848 reports)
- Dexamethasone (1,696 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026