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]
