85/100 · Critical
Manufactured by Avyxa Pharma, LLC
Leucovorin Calcium Adverse Events: High Serious Reaction Rate
34,777 FDA adverse event reports analyzed
Last updated: 2026-05-12
LEUCOVORIN CALCIUM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Avyxa Pharma, LLC. Based on analysis of 34,777 FDA adverse event reports, LEUCOVORIN CALCIUM has a safety score of 85 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for LEUCOVORIN CALCIUM include DIARRHOEA, NAUSEA, VOMITING, NEUTROPENIA, PYREXIA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for LEUCOVORIN CALCIUM.
Leucovorin Calcium has a safety concern score of 85 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 34,777 adverse event reports for this medication, which is primarily manufactured by Avyxa Pharma, Llc.
The most commonly reported adverse events include Diarrhoea, Nausea, Vomiting. Of classified reports, 90.4% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Leucovorin Calcium has a high rate of serious adverse events, particularly gastrointestinal and hematological issues.
The most common reactions include diarrhea, nausea, and vomiting, which are frequently reported. Hematological issues such as neutropenia and thrombocytopenia are also commonly reported, indicating potential bone marrow suppression. The drug is associated with a significant number of serious reactions, including sepsis, pneumonia, and renal failure.
Patients taking Leucovorin Calcium should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Leucovorin Calcium is contraindicated in patients with known hypersensitivity to the drug. It may also interact with other drugs, leading to adverse effects. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Leucovorin Calcium received a safety concern score of 85/100 (high concern). This is based on a 90.4% serious event ratio across 18,094 classified reports. The score accounts for 34,777 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Male: 8,644, Female: 7,199, Unknown: 156. The most frequently reported age groups are age 70 (413 reports), age 63 (404 reports), age 67 (380 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 18,094 classified reports for LEUCOVORIN CALCIUM:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Leucovorin Calcium is contraindicated in patients with known hypersensitivity to the drug. It may also interact with other drugs, leading to adverse effects.
If you are taking Leucovorin Calcium, here are important things to know. The most commonly reported side effects include diarrhoea, nausea, vomiting, neutropenia, pyrexia. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should report any new or worsening symptoms to their healthcare provider immediately. Follow all prescribed dosing instructions and do not alter the dosage without consulting a healthcare professional. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA continues to monitor the safety of Leucovorin Calcium and has not issued any specific warnings or recalls. However, healthcare providers should be vigilant about monitoring patients for serious adverse events.
The FDA has received approximately 34,777 adverse event reports associated with Leucovorin Calcium. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Leucovorin Calcium include Diarrhoea, Nausea, Vomiting, Neutropenia, Pyrexia. By volume, the top reported reactions are: Diarrhoea (1,707 reports), Nausea (1,316 reports), Vomiting (1,078 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Leucovorin Calcium.
Out of 18,094 classified reports, 16,364 (90.4%) were classified as serious and 1,730 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Leucovorin Calcium break down by patient sex as follows: Male: 8,644, Female: 7,199, Unknown: 156. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Leucovorin Calcium adverse events are: age 70: 413 reports, age 63: 404 reports, age 67: 380 reports, age 64: 373 reports, age 68: 373 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Leucovorin Calcium adverse event reports is Avyxa Pharma, Llc. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Leucovorin Calcium include: Off Label Use, Fatigue, Disease Progression, Drug Ineffective, Dyspnoea. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Leucovorin Calcium to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Leucovorin Calcium has a safety concern score of 85 out of 100 (high concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. Leucovorin Calcium has a high rate of serious adverse events, particularly gastrointestinal and hematological issues.
Key safety signals identified in Leucovorin Calcium's adverse event data include: Neutropenia and thrombocytopenia are key safety signals, indicating potential bone marrow suppression.. Gastrointestinal issues like diarrhea, nausea, and vomiting are frequently reported, suggesting a high incidence of these side effects.. Serious reactions such as sepsis, pneumonia, and renal failure are also significant safety signals.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Leucovorin Calcium is contraindicated in patients with known hypersensitivity to the drug. It may also interact with other drugs, leading to adverse effects. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Leucovorin Calcium.
Patients should report any new or worsening symptoms to their healthcare provider immediately. Follow all prescribed dosing instructions and do not alter the dosage without consulting a healthcare professional.
Leucovorin Calcium has 34,777 adverse event reports on file with the FDA. The most common reactions include diarrhea, nausea, and vomiting, which are frequently reported. The volume of reports for Leucovorin Calcium reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of Leucovorin Calcium and has not issued any specific warnings or recalls. However, healthcare providers should be vigilant about monitoring patients for serious adverse events. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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