OpenClaim

Levoleucovorin Side Effects

The most commonly reported side effects of levoleucovorin include diarrhoea, off label use, and nausea, based on 24,021 FDA adverse event reports from 2004 to 2025. 6.6% of reports found the drug to be ineffective.

Levoleucovorin side effects

Percentages show how often each reaction appears relative to total reports for levoleucovorin.

1
Diarrhoea9.3%2,225
2
Off Label Use8.6%2,061
3
Nausea8.0%1,921
4
Neutropenia6.7%1,610
5
Drug Ineffective6.6%1,596
6
Fatigue5.4%1,292
7
Disease Progression5.2%1,249
8
Neuropathy Peripheral5.1%1,233
9
Vomiting5.0%1,211
10
Febrile Neutropenia4.6%1,100
11
Thrombocytopenia4.2%1,008
12
Pyrexia4.1%977
13
Death3.9%948
14
Anaemia3.7%887
15
Asthenia3.1%748

These are voluntary reports and do not establish that levoleucovorin caused these reactions.

Report severity

92.9%Serious22,310 reports
38.7%Hospitalizations9,286 reports
14.9%Fatal3,588 reports

Seriousness is determined by the reporter, not by OpenClaim.

Levoleucovorin drug interactions

Other drugs that appear in adverse event reports alongside levoleucovorin. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Fluorouracil51.2%12,304
2
Oxaliplatin45.0%10,813
3
Irinotecan-hydrochloride28.9%6,944
4
Bevacizumab19.5%4,688
5
Methotrexate10.3%2,480
6
Panitumumab8.5%2,036
7
Capecitabine5.0%1,202
8
Cetuximab4.7%1,127
9
Aflibercept4.3%1,027
10
Vincristine-sulfate4.1%987
11
Cyclophosphamide3.9%926
12
Docetaxel3.7%893
13
Dexamethasone3.6%875
14
Rituximab3.5%848
15
Cytarabine3.3%804

Taken alongside

1
Fluorouracil16.5%3,969
2
Oxaliplatin9.8%2,345
3
Dexamethasone9.7%2,337
4
Methotrexate7.5%1,802
5
Ondansetron7.1%1,710
6
Irinotecan-hydrochloride6.8%1,628
7
Acetaminophen6.5%1,557
8
Prednisone4.6%1,098
9
Pantoprazole-sodium4.5%1,091
10
Omeprazole4.0%965
11
Loperamide-hydrochloride3.4%824
12
Palonosetron-hydrochloride3.4%815
13
Folic-acid3.3%783
14
Aspirin3.2%774
15
Amlodipine3.2%774

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports levoleucovorin side effects

39.0% of levoleucovorin adverse event reports involve female patients and 46.4% involve male patients. The largest age group is adult at 54%. These figures reflect who reports side effects, not underlying risk.

Sex

Female39.0%
Male46.4%
Unknown14.6%

Age group

< 20.9%
2–112.2%
12–171.8%
18–6454.3%
65+40.9%

What is levoleucovorin used for

Conditions and purposes for which patients were taking levoleucovorin when the adverse event was reported.

AcidosisAcquired Immunodeficiency SyndromeAcute Kidney InjuryAcute LeukaemiaAcute Lymphocytic LeukaemiaAcute Lymphocytic Leukaemia RecurrentAcute Myeloid LeukaemiaAdenocarcinomaAdenocarcinoma GastricAdenocarcinoma MetastaticAdenocarcinoma Of AppendixAdenocarcinoma Of ColonAdenocarcinoma Of Colon Stage IiiAdenocarcinoma Of The Gastroesophageal JunctionAdenocarcinoma Pancreas

Showing 15 of 794 indications

Levoleucovorin brand names and reporting trend

Levoleucovorin is sold under brand names including Levoleucovorin Calcium, Khapzory.

Brand names

Levoleucovorin Calcium30,320
Khapzory994

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking levoleucovorin with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.