What the label lists and what reports show
Levoleucovorin side effects
Levoleucovorin's FDA label: “The most common adverse reactions (≥20%) in patients receiving high-dose methotrexate therapy with levoleucovorin rescue are stomatitis and vomiting.” FAERS holds 3,706 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is nausea (288 reports).
- Generic listed
Check it at the source: the levoleucovorin FDA label on DailyMed (effective August 29, 2023, Slate Run Pharmaceuticals); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (≥20%) in patients receiving high-dose methotrexate therapy with levoleucovorin rescue are stomatitis and vomiting.
Table 2 Adverse Reactions with High-Dose Methotrexate Therapy
| Reaction | Adverse Reactions All Grades (%) | Levoleucovorin n = 16 Grades 3-4 (%) |
|---|---|---|
| Stomatitis | 38 | 6 |
| Vomiting | 38 | 0 |
| Nausea | 19 | 0 |
| Diarrhea | 6 | 0 |
| Dyspepsia | 6 | 0 |
| Typhlitis | 6 | 6 |
| Dyspnea | 6 | 0 |
| Dermatitis | 6 | 0 |
| Confusion | 6 | 0 |
| Neuropathy | 6 | 0 |
| Renal function abnormal | 6 | 0 |
| Taste perversion | 6 | 0 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are described elsewhere in the labeling: Hypercalcemia [see Warnings and Precautions ( 5.1 )] Increased gastrointestinal toxicities with fluorouracil [see Warnings and Precautions ( 5.2 )] The most common adverse reactions (≥20%) in patients receiving high-dose methotrexate therapy with levoleucovorin rescue are stomatitis and vomiting. ( 6.1 ) The most common adverse reactions (>50%) in patients receiving levoleucovorin in combination with fluorouracil for metastatic colorectal cancer are stomatitis, diarrhea, and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Slate Run Pharmaceuticals at 1-800-341-9214 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. High-Dose Methotrexate Therapy Table 2 presents the frequency of adverse reactions which occurred during the administration of 58 courses of high-dose methotrexate 12 grams/m 2 followed by levoleucovorin rescue for osteosarcoma in 16 patients aged 6 to 21 years. …
Source: FDA drug label, Slate Run Pharmaceuticals, effective August 29, 2023 (SPL set 124bc214-62f8-40f9-a227-a35e2d1ff2a0), via openFDA; the full label on DailyMed
What do FAERS reports show?
3,706 reports list levoleucovorin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 545 are coded as a death and 1,415 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 23 reactions below, 8 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Levoleucovorin: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions