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Leucovorin Side Effects

Not all side effects for leucovorin may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to leucovorin: injectable, powder for solution, solution, tablet

In addition to its needed effects, some unwanted effects may be caused by leucovorin. In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking leucovorin:

Rare
  • Skin rash, hives, or itching
  • wheezing

If any of the following side effects occur while taking leucovorin, check with your doctor or nurse as soon as possible:

Rare - reported with use in treatment of cancer
  • Convulsions (seizures)

For Healthcare Professionals

Applies to leucovorin: compounding powder, injectable powder for injection, injectable solution, oral tablet

General

Adverse events attributed to use of leucovorin/folinic acid by itself include allergic sensitization, including anaphylactoid reactions and urticaria; gastrointestinal and hematologic adverse events were common when used with fluorouracil.[Ref]

Gastrointestinal

Very common (10% or more): Stomatitis (75%, when used with fluorouracil), nausea (74%, when used with fluorouracil), diarrhea (66%, when used with fluorouracil), vomiting (46%, when used with fluorouracil), dehydration (when used with fluorouracil)
Common (1% to 10%): Constipation (when used with fluorouracil)
Rare (less than 0.1%): Gastrointestinal disorders (after high doses)
Frequency not reported: Mucositis (when used with fluorouracil), cheilitis (when used with fluorouracil)[Ref]

When used with fluorouracil, diarrhea and dehydration have resulted in hospital admission and death.[Ref]

Hematologic

Very common (10% or more): Leucopenia (69%, when used with fluorouracil)
Common (1% to 10%): Thrombocytopenia (when used with fluorouracil)[Ref]

Hypersensitivity

Very rare (less than 0.01%): Allergic reactions (sensitization, including anaphylactoid reactions, shock, and urticaria)
Frequency not reported: Stevens Johnson Syndrome and Toxic Epidermal Necrolysis (in combination with other agents)[Ref]

Dermatologic

Very common (10% or more): Alopecia (42%, when used with fluorouracil), dermatitis (21%, when used with fluorouracil)
Frequency not reported: Palmar-plantar erythrodysesthesia (when used with fluorouracil)[Ref]

Other

Very common (10% or more): Lethargy/malaise/fatigue (13%, when used with fluorouracil)
Uncommon (0.1% to 1%): Pyrexial reactions (following parenteral administration)[Ref]

Metabolic

Very common (10% or more): Anorexia (14%, when used with fluorouracil)
Frequency not reported: Hyperammonemia (when used with fluorouracil)

Immunologic

Common (1% to 10%): Infection (when used with fluorouracil)[Ref]

Nervous system

Rare (less than 0.1%): Increase in the frequency of attacks in epileptics, seizures, syncope[Ref]

Psychiatric

Rare (less than 0.1%): Insomnia, agitation, depression[Ref]

References

1. Cerner Multum, Inc. "Australian Product Information." O 0

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. "Product Information. Leucovorin Calcium (leucovorin)." Bedford Laboratories, Bedford, OH.

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