Eulexin Side Effects

Generic name: flutamide

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

Some side effects of Eulexin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to flutamide: oral capsule

Stop taking flutamide (the active ingredient contained in Eulexin) and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

In rare cases, flutamide has caused severe liver damage resulting in death or hospitalization. Notify your doctor immediately if you develop nausea, vomiting, abdominal pain, unusual fatigue, loss of appetite, "flu-like" symptoms, yellow skin or eyes, itching, clay-colored stools, or dark urine. These symptoms may be early signs of liver damage.

Other, less serious side effects may be more likely to occur. Continue to take flutamide and talk to your doctor if you experience

• hot flashes,

• diarrhea,

• skin rash,

• increased skin sensitivity to sunlight,

• loss of sex drive,

• impotence,

• lowered sperm count,

• enlarged breasts,

• amber or greenish discoloration of the urine,

• rectal bleeding or inflammation, or

• blood in the urine.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

For Healthcare Professionals

Applies to flutamide: oral capsule

General

In general, flutamide (the active ingredient contained in Eulexin) has been used concomitantly with LHRH agonists or after bilateral orchiectomy. Therefore, little data are available on the side effects of flutamide alone.

Hepatic

Nineteen cases of severe flutamide (the active ingredient contained in Eulexin) related hepatotoxicity were reported by the FDA in 1993. The flutamide related hepatitis developed 56 to 80 days after the beginning of therapy and was mainly cytolytic. Four of the cases involved massive hepatic necrosis with fatal outcomes. The mechanism of action was believed to be direct hepatotoxicity.

In a study of 1,091 patients with prostate cancer treated with flutamide and an LHRH agonist, four patients (0.36%) developed severe hepatotoxicity in the first four weeks of therapy. Serum aminotransferases increased more than four times normal values. Alkaline phosphatase increased more than six times normal values in one patient. Total bilirubin was elevated in two patients. Only two patients developed clinical manifestations, including fatigue, anorexia, weight loss, nausea, and vomiting. None of the remaining 1,089 patients had significant elevations in liver function tests although transient, mild elevations in AST and ALT occasionally occurred.

In most cases, discontinuation of flutamide results in resolution of symptoms.

A case of fatal liver complications has been reported where the drug was prescribed for an 18 year old woman for the treatment of minor acne and hirsutism. The risk of lethal hepatic complications makes the risk-benefit ratio unacceptable when flutamide is being considered to treat disorders such as polycystic ovaries, and especially for benign complaints such as alopecia, hirsutism, and acne.

Hepatic side effects have included elevations in serum transaminases as well as cases of cholestatic jaundice, hepatic necrosis, hepatic encephalopathy, and fatal hepatotoxicity.

Hematologic

Hematologic side effects have included anemia (6%), leukopenia (3%), and thrombocytopenia (1%). Flutamide (the active ingredient contained in Eulexin) has also been implicated in cases of methemoglobinemia, sulphemoglobinemia and neutropenia. In addition, eosinophilia has been reported in association with some cases of hepatotoxicity.

Nervous system

Nervous system side effects have been reported in less than 1% of patients and include drowsiness, dizziness, sedation, and confusion.

Renal

Renal side effects including renal failure (in association with severe hepatotoxicity) have been reported.

Cardiovascular

Cardiovascular side effects reported include hypertension (1%), thromboembolism, and edema.

Dermatologic

Pseudoporphyria (blisters, increased skin fragility, and erosions in sun-exposed areas) was reported in a 68-year-old man being treated for prostate cancer with appropriate doses of flutamide (the active ingredient contained in Eulexin) and goserelin. The patient presented with skin fragility and blisters on the back of the hands. After replacing the flutamide with bicalutamide, the lesions healed.

Dermatologic side effects including rash (3%), alopecia, sweating, and cases of photosensitivity/photoallergy have been reported. One case of flutamide-induced pseudoporphyria has also been reported.

Endocrine

Endocrine side effects including hot flashes (29% to 63%), gynecomastia (up to 19%), fever, and breast tenderness (7%) have been reported.

Gastrointestinal

Two female patients receiving flutamide (the active ingredient contained in Eulexin) for the treatment of bulimia nervosa noted decreased symptoms within a week after initiation of therapy. Both patients relapsed after the drug was later withdrawn.

Gastrointestinal side effects including mucositis, diarrhea, nausea, vomiting, abdominal pain, anorexia, and either weight loss or gain have been reported.

Musculoskeletal

Musculoskeletal side effects including muscle cramps in up to 15% of patients have been reported.

Psychiatric

Psychiatric side effects including depression, anxiety, and nervousness have been reported. One case report of mania has also been reported.

Genitourinary

Genitourinary side effects including impotence and loss of libido have been reported.

Other

Several studies have described a flutamide (the active ingredient contained in Eulexin) withdrawal syndrome in which significant reductions in prostate-specific antigen (PSA) levels are noted following the discontinuation of flutamide therapy in patients with hormone-refractory prostate cancer.

Several studies have evaluated the effect of concurrent discontinuation of flutamide and initiation of aminoglutethimide therapy in patients with hormone-refractory prostate cancer. In one study, serum PSA levels declined by more than 80% for more than four weeks in 14 out of 29 (48%) patients. Clinical improvement was also noted. Some authors propose prolonged flutamide therapy may result in the selective proliferation of cancer cell lines with androgen receptors which recognize hydroxyflutamide as an androgenic agonist. Additional research is needed to fully evaluate this phenomenon.

Other side effects have included flutamide withdrawal syndrome.

Respiratory

Respiratory side effects including one case of pneumonitis have been reported.

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