Fluta-cell 250 Side Effects

Monotherapy: The most common undesirable effects observed during clinical trials using Flutamide tablets 250 mg are gynaecomastia and/or chest pain, sometimes accompanied by galactorrhoea. Micronodular changes in the corpus mammae may occur. These undesirable effects are reversible when treatment is discontinued or when dose is reduced.
Initially, monotherapy using Flutamide tablets 250 mg may lead to a reversible increase in serum testosterone, as well as to flush and changes in hair growth.
Cardiovascular disorders occur rarely, but with significantly less probability than with diethylstilbestrol.
Diarrhoea, nausea, vomiting, increased appetite, insomnia, tiredness, transient abnormal liver function and hepatitis have been reported occassionally.
The following undesirable effects occur rarely: decreased libido, dyspepsia, anorexia, ulcer-like pain, heartburn, constipation, oedema, ecchymoses, herpes zoster, pruritus, lupoid syndrome, headache, hot flashes, dizziness, weakness, malaise, blurred vision, thirst, chest pain, anxiety, depression and lymphedoema, loss or head hair and muscle spasms.
Combined treatment: The most common undesirable effect observed during clinical trials using Flutamide tablets 250 mg and LH-RH agonist were hot flashes, decreased libido, impotence, diarrhoea, nausea and vomiting. With the exception of diarrhoea, these undesirable effects are known to occur with an LH-RH agonist alone, and with a comparable incidence.
Gynaecomastia which commonly occurs with Flutamide monotherapy was reduced greatly in combination treatment.
Clinical trials showed no significant difference in the incidence of gynaecomastia between placebo / LH-RH agonist and Flutamide / LH-RH agonist treatment.
Hepatitis occurred occasionally.
The following occurred rarely: anaemia, leucopenia, thrombopenia, non-specific gastrointestinal complaints, anorexia, rash, neuromuscular symptoms, jaundice, urogenital tract symptoms, hypertension, oedema and CNS side effects (somnolence, depression, confusion, anxiety and nervousness).
Pulmonary symptoms such as dyspnea occurred very rarely.
The following further undesirable effects caused by Flutamide were also reported: haemolytic anaemia, macrocytic anaemia, methaemoglobinaemia, thromboembolism, photosensitivity reactions including arythema, ulcerations, bullous eruptions and epidermal necrolysis.
Cholestatic jaundice as well as hepatic encephalopathy and liver cell necrosis, particularly in patients with liver metastasis, were also observed. These undesirable effects usually receded once treatment is discontinued. However, there were isolated reports of liver damage with a fatal outcome in connection with the use of Flutamide.