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Eulexin Side Effects

Generic name: flutamide

Medically reviewed by Drugs.com. Last updated on Jun 21, 2022.

Note: This document contains side effect information about flutamide. Some dosage forms listed on this page may not apply to the brand name Eulexin.

Applies to flutamide: oral capsules.

Warning

    Hepatotoxicity
  • Severe liver injury (i.e., increased serum transaminase concentrations, jaundice, hepatic encephalopathy, acute hepatic failure) reported, sometimes resulting in hospitalization and/or rarely death; manifestations generally occurred within first 3 months and in some patients, were reversible after discontinuance.1

  • Measure serum transaminase concentrations prior to initiation of therapy, monthly during first 4 months, and periodically thereafter.1

  • Immediately measure serum transaminase (especially ALT) concentrations if manifestations suggestive of liver dysfunction (e.g., nausea, vomiting, abdominal pain, fatigue, anorexia, flu-like symptoms, hyperbilirubinuria, jaundice, right upper quadrant tenderness) occur.1

  • Immediately discontinue if jaundice develops or serum ALT concentration is >2 times ULN; monitor liver function closely until resolves.1

Side effects include:

Combined therapy with LHRH analog: hot flashes, loss of libido, impotence, diarrhea, nausea, vomiting, gynecomastia.

Cystitis, rectal bleeding, proctitis, skin rash, hematuria also frequent when flutamide (the active ingredient contained in Eulexin) combined with LHRH analog and radiation therapy.

For Healthcare Professionals

Applies to flutamide: oral capsule.

Hepatic

Rare (0.01% to 0.1%): Abnormal liver function tests, hepatic dysfunction, jaundice

Very rare (less than 0.01%): Cholestatic jaundice, hepatic encephalopathy, liver cell necrosis, fatal hepatotoxicity[Ref]

Hematologic

Rare (0.01% to 0.1%): Anemia, leucopenia, thrombocytopenia

Very rare (less than 0.01%): Hemolytic anemia, megalocytic anemia, methemoglobinemia, sulfhemoglobinemia, macrocytic anemia[Ref]

Nervous system

Rare (less than 0.1%): Dizziness, headache, numbness, drowsiness

Frequency not reported: Tiredness, malaise[Ref]

Cardiovascular

Very common (10% or more): Hot flushes

Rare (less than 0.1%): Cardiovascular disorders, hypertension, lymphoedema

Frequency not reported: QT prolongation, thromboembolism[Ref]

Dermatologic

Rare (0.01% to 0.1%): Urticaria, pruritus, ecchymosis, alteration of the hair growth pattern and loss of hair (head), rash

Very rare (less than 0.01%): Photosensitivity reactions, erythema, ulcers, bullous eruptions, epidermal necrosis[Ref]

Endocrine

Very common (10% or more): Gynecomastia (19%)

Common (1% to 10%): Breast tenderness (7%)[Ref]

Gastrointestinal

Very common (10% or more): Nausea, vomiting, diarrhea

Rare (less than 0.1%): Constipation, ulcer-like pain, dyspepsia, colitis, upset stomach, heartburn, abdominal pain[Ref]

Musculoskeletal

Rare (0.01% to 0.1%): Muscle cramps, neuromuscular symptoms, reduced bone mineral density, osteoporotic disorders, arthralgia, myalgia[Ref]

Psychiatric

Rare (0.01% to 0.1%): Anxiety, depression, confusion, nervousness[Ref]

Genitourinary

Frequency not reported: Loss of libido[Ref]

Respiratory

Rare (0.01% to 0.1%): Interstitial pneumonitis, dyspnea

Very rare (less than 0.01%): Cough, interstitial lung disease[Ref]

Immunologic

Rare (0.01% to 0.1%): Lupus-like syndrome

Very rare (less than 0.01%): Herpes zoster[Ref]

Ocular

Rare (less than 0.1%): Blurred vision[Ref]

Metabolic

Common (1% to 10%): Increased appetite

Rare (less than 0.1%): Anorexia[Ref]

Oncologic

Very rare (less than 0.01%): Neoplasm of the male breast[Ref]

Frequently asked questions

References

1. "Product Information. Eulexin (flutamide)." Schering Corporation (2002):

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

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

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.