Flutamid STADA
Nonsteroidal Antiandrogen for Prostate Cancer Treatment
Quick Facts About Flutamid STADA
Key Takeaways About Flutamid STADA
- Antiandrogen for prostate cancer: Flutamide blocks male hormone receptors in prostate tissue, slowing or stopping androgen-dependent tumour growth
- Liver monitoring is essential: Flutamide carries a risk of hepatotoxicity (liver damage), including rare cases of fatal liver failure – regular liver function tests are mandatory
- Three times daily dosing: The standard dose is 250 mg three times a day (every 8 hours), taken with food
- Not for use by women: This medication is designed exclusively for men with prostate cancer and must not be taken by women
- Often combined with LHRH agonists: Flutamide is frequently used alongside LHRH agonists (e.g., goserelin, leuprolide) for combined androgen blockade, which is more effective than either agent alone
What Is Flutamid STADA and What Is It Used For?
Flutamid STADA contains the active ingredient flutamide, a nonsteroidal antiandrogen that blocks the effects of male sex hormones (androgens) on target tissues. It is primarily used in the treatment of prostate cancer, either alone or in combination with LHRH agonists or following surgical castration (orchiectomy).
Prostate cancer is one of the most common cancers affecting men worldwide, with the European Association of Urology (EAU) estimating that approximately 450,000 new cases are diagnosed in Europe each year. The growth of prostate cancer cells is largely driven by androgens, particularly testosterone and its more potent derivative dihydrotestosterone (DHT). By interfering with androgen signalling, treatments such as flutamide can slow or halt tumour progression.
Flutamide belongs to a class of drugs known as nonsteroidal antiandrogens. Unlike steroidal antiandrogens, flutamide does not have hormonal activity of its own. Instead, it acts as a pure androgen receptor antagonist. After oral administration, flutamide is rapidly absorbed and undergoes extensive first-pass metabolism in the liver, converting primarily to its active metabolite 2-hydroxyflutamide, which is responsible for most of the drug's pharmacological activity. This metabolite competitively binds to androgen receptors in prostate tissue, preventing testosterone and DHT from activating these receptors and stimulating cancer cell growth.
In clinical practice, flutamide is used in several key settings. First, it is often prescribed as part of combined androgen blockade (CAB) – a treatment strategy that combines a nonsteroidal antiandrogen with a luteinising hormone-releasing hormone (LHRH) agonist such as goserelin (Zoladex) or leuprolide (Lupron). The rationale behind this combination is that LHRH agonists suppress testicular testosterone production (accounting for approximately 90–95% of total androgens), while flutamide blocks the remaining androgens produced by the adrenal glands. This dual approach provides more complete androgen suppression than either therapy alone.
Flutamide is also used in men who have undergone bilateral orchiectomy (surgical removal of the testicles), to block any residual androgen activity from adrenal sources. Additionally, flutamide may be started a few weeks before LHRH agonist therapy to prevent the testosterone flare phenomenon – a temporary surge in testosterone levels that occurs when LHRH agonists are first administered, which can temporarily worsen cancer symptoms.
Flutamide was one of the first nonsteroidal antiandrogens to be approved for prostate cancer treatment and has been used clinically since the 1980s. While newer antiandrogens such as bicalutamide and enzalutamide have since become available, flutamide remains an important therapeutic option, particularly in resource-limited settings where newer agents may not be accessible or affordable. The World Health Organization (WHO) recognises antiandrogen therapy as a key component in the management of advanced prostate cancer.
What Should You Know Before Taking Flutamid STADA?
Before starting flutamide, your doctor must assess your liver function and overall health. This medication is contraindicated in women and in patients with severe liver problems. Regular liver function monitoring is mandatory throughout treatment due to the risk of hepatotoxicity.
Contraindications
You should not take Flutamid STADA if any of the following apply:
- You are a woman – this medication must not be used by women under any circumstances. It is designed exclusively for the treatment of prostate cancer in men
- Allergy to flutamide or any of the other ingredients in the tablet (listed in the "What Does Flutamid STADA Contain?" section) – allergic reactions may include skin rash, itching, swelling, or difficulty breathing
- Severe liver disease – because flutamide is extensively metabolised by the liver and carries a risk of hepatotoxicity, it must not be used in patients with pre-existing severe hepatic impairment
If you are uncertain about whether any of the above conditions apply to you, consult your doctor or pharmacist before starting treatment.
Warnings and Precautions
Talk to your doctor or pharmacist before taking Flutamid STADA if you have any of the following:
- Liver or kidney problems – your doctor will need to perform baseline liver function tests and may require more frequent monitoring during treatment. Impaired renal function may affect the clearance of flutamide metabolites
- Cardiovascular disease, including heart rhythm disorders (arrhythmias) – flutamide may increase the risk of QT prolongation, a heart rhythm disturbance that can be dangerous. This risk is particularly relevant if you are already taking medications known to affect heart rhythm
- Heart disease with normally functioning testicles – in patients who have not undergone medical or surgical castration, flutamide may cause fluid retention, which can increase the workload on the heart and worsen existing cardiovascular conditions
Stop taking Flutamid STADA immediately and contact your doctor if you develop any of the following signs of hepatitis (liver inflammation): yellowing of the skin or whites of the eyes (jaundice), itching, dark-coloured urine, abdominal pain, tiredness, loss of appetite, nausea, or vomiting. Rare cases of fatal liver failure have been reported with flutamide use. Your doctor will monitor your liver function with regular blood tests throughout treatment.
During treatment, your doctor will perform regular blood tests to monitor liver function. These tests typically include measurements of alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin. Testing is usually done before starting treatment, monthly during the first four months, and periodically thereafter. If liver enzymes rise to more than two to three times the upper limit of normal, your doctor may reduce the dose or discontinue treatment.
Pregnancy, Breastfeeding and Fertility
Flutamid STADA must not be used by women. This medication is specifically developed for men with prostate cancer. Men taking flutamide should use appropriate contraception (condoms) during treatment, as the drug could potentially affect foetal development if exposure occurs through seminal fluid. If your partner becomes pregnant during your treatment, inform your doctor immediately.
Driving and Operating Machinery
At the start of treatment with flutamide, you may experience drowsiness or fatigue. These effects tend to diminish as treatment continues. If you feel drowsy or dizzy, you should not drive or operate machinery until the symptoms subside. You are responsible for assessing your own fitness to drive – the use of this medicine may impair your ability due to its side effects. Always discuss with your doctor or pharmacist if you are unsure.
Food, Drink and Alcohol
Flutamide tablets should be swallowed whole with a glass of water, preferably after meals. Taking the tablets with food improves tolerability and may reduce gastrointestinal side effects such as nausea. You should avoid consuming large quantities of alcohol during treatment with flutamide, as both alcohol and flutamide are metabolised by the liver. Excessive alcohol consumption may increase the risk of liver toxicity.
Important Information About the Ingredients
Flutamid STADA contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to certain sugars, contact your doctor before taking this medicine. This medicine also contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially sodium-free.
How Does Flutamid STADA Interact with Other Drugs?
Flutamide can interact with several medications, including anticoagulants (blood thinners), drugs that affect heart rhythm (QT-prolonging agents), and LHRH agonists used in prostate cancer treatment. Always inform your doctor about all medications you are taking, including over-the-counter products and herbal supplements.
Drug interactions with flutamide are clinically important and can affect both safety and efficacy. The most significant interactions involve medications that affect blood clotting, heart rhythm, and liver metabolism. Because flutamide undergoes extensive hepatic metabolism, drugs that affect liver enzyme activity may alter flutamide blood levels. The following table summarises the key known interactions.
Significant Drug Interactions
| Drug | Category | Effect | Recommendation |
|---|---|---|---|
| Warfarin and other anticoagulants | Blood thinners | Flutamide may enhance anticoagulant effect, increasing bleeding risk | Monitor INR more frequently; dose adjustment of anticoagulant may be needed |
| Quinidine, Procainamide | Antiarrhythmics (Class IA) | Additive QT prolongation risk; may cause dangerous heart rhythm disturbances | Avoid combination if possible; ECG monitoring required if co-prescribed |
| Amiodarone, Sotalol | Antiarrhythmics (Class III) | Increased risk of QT prolongation and torsades de pointes | Use with extreme caution; regular ECG monitoring essential |
| Methadone | Opioid analgesic | Additive QT prolongation risk | Monitor cardiac function; consider alternative pain management |
| Moxifloxacin | Fluoroquinolone antibiotic | Increased risk of QT prolongation | Use alternative antibiotic if possible |
| Antipsychotics (e.g., haloperidol, quetiapine) | Psychiatric medications | Additive QT prolongation risk | ECG monitoring; discuss risk-benefit with treating physician |
| LHRH agonists (goserelin, leuprolide) | Hormonal anticancer agents | Intentional combination for combined androgen blockade; may also additively prolong QT | Standard combination therapy; monitor cardiac function as both agents may affect QT interval |
The interactions listed above are not exhaustive. Always tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take, including prescription medicines, over-the-counter products, vitamins, and herbal supplements. Your doctor will evaluate potential interactions and adjust your treatment accordingly.
What Is the Correct Dosage of Flutamid STADA?
The standard recommended dose of Flutamid STADA is one 250 mg tablet taken three times daily at approximately eight-hour intervals. Tablets should be swallowed whole with water, preferably after meals. Always follow your doctor's specific instructions regarding dosing.
Flutamide dosing is relatively straightforward, as the same dose is typically used in all adult male patients. However, your doctor may adjust the dosing schedule to suit your individual needs and practical circumstances. It is essential to take the medication at regular intervals to maintain consistent blood levels of the active metabolite.
Adults
Standard Adult Dosage
250 mg (one tablet) three times daily, taken at approximately eight-hour intervals (e.g., 6:00 AM, 2:00 PM, and 10:00 PM). Tablets should be swallowed whole with a glass of water, preferably after meals.
This corresponds to a total daily dose of 750 mg flutamide. Your doctor will determine the exact timing and duration of treatment based on your condition, response to therapy, and overall treatment plan.
When used in combination with an LHRH agonist, flutamide is typically started at the same time as, or a few days to weeks before, the LHRH agonist. This early initiation helps to block the testosterone flare that occurs when LHRH agonists are first administered. The duration of flutamide treatment varies and is determined by your oncologist based on disease response, tolerability, and treatment goals.
Children
Flutamide is not indicated for use in children. Prostate cancer is a disease that affects adult men, and there is no established paediatric dosing for this medication.
Elderly Patients
No specific dose adjustment is routinely required for elderly patients. However, since prostate cancer most commonly affects older men, many patients taking flutamide are in older age groups. These patients may have reduced hepatic or renal function, and your doctor will monitor your liver and kidney function closely and may adjust the dose if necessary.
Missed Dose
If you miss an entire day’s dose, resume taking the normal dose the following day. Do not take a double dose to make up for a missed dose. If you miss a single dose during the day, take it as soon as you remember, unless it is nearly time for the next scheduled dose. In that case, skip the missed dose and continue with your regular dosing schedule. Consult your doctor or pharmacist if you are unsure about what to do.
Overdose
If you accidentally take more tablets than prescribed, contact your doctor immediately or go to the nearest emergency department. Bring any remaining tablets together with the packaging and this information sheet so that medical staff know what you have taken. Symptoms of overdose may include nausea, vomiting, and exaggerated drug effects. There is no specific antidote for flutamide overdose – treatment is supportive and symptomatic.
Do not stop taking Flutamid STADA or change your dosage without first consulting your doctor. Stopping antiandrogen therapy prematurely may allow cancer to progress. Even if you feel well, continue taking your tablets as directed. When your course of treatment is nearing completion, check with your doctor about whether to continue or taper the medication.
What Are the Side Effects of Flutamid STADA?
Like all medicines, flutamide can cause side effects, although not everybody gets them. The most common side effect when taking flutamide alone is breast tenderness and enlargement (gynaecomastia). The most serious risk is liver toxicity – seek immediate medical attention if you develop jaundice, dark urine, or persistent abdominal pain.
Side effects may differ depending on whether flutamide is taken alone (monotherapy) or in combination with an LHRH agonist. When combined with an LHRH agonist, some side effects related to overall androgen suppression (such as hot flushes and reduced libido) become more prominent. The frequency categories used below follow international medical convention based on clinical trial data and post-marketing surveillance reports.
When Taking Flutamid STADA Alone (Monotherapy)
Very Common
May affect more than 1 in 10 people
- Gynaecomastia – breast tenderness and enlargement around the nipple area, sometimes with milky discharge. This is the most frequent side effect and is usually reversible upon dose reduction or discontinuation
Common
May affect up to 1 in 10 people
- Nausea and vomiting
- Diarrhoea
- Increased appetite
- Sleep disturbances (insomnia)
- Fatigue and tiredness
- Liver function abnormalities (elevated liver enzymes)
Rare
May affect up to 1 in 1,000 people
- Decreased libido (reduced sexual desire)
- Gastrointestinal upset, decreased appetite, heartburn, constipation
- Peripheral oedema (swelling of feet and lower legs)
- Skin bruising, herpes zoster (shingles), itching
- Lupus-like syndrome (inflammatory condition affecting skin and joints)
- Flushing, headache, drowsiness, malaise
- Blurred vision, thirst, chest pain
- Anxiety, depression, swollen lymph nodes
Very Rare
May affect up to 1 in 10,000 people
- Male breast cancer (extremely rare)
- Photosensitivity (increased sensitivity to sunlight)
When Taking Flutamid STADA with an LHRH Agonist
Very Common
May affect more than 1 in 10 people
- Hot flushes (vasomotor symptoms)
- Decreased libido or erectile dysfunction
- Diarrhoea
- Nausea and vomiting
Uncommon
May affect up to 1 in 100 people
- Gynaecomastia (breast enlargement)
- Hepatitis (liver inflammation)
Rare
May affect up to 1 in 1,000 people
- Blood count changes (haematological abnormalities)
- Liver problems, jaundice (yellowing of skin and eyes)
- Decreased appetite, gastrointestinal disturbance, skin rash
- Peripheral oedema, muscle pain or twitching
- High blood pressure, drowsiness, depression
- Confusion, anxiety, nervousness
- Genital discomfort
Very Rare
May affect up to 1 in 10,000 people
- Severe respiratory difficulties – seek immediate medical attention
- Certain types of anaemia (blood disorders)
- Photosensitivity (sensitivity to sunlight)
- Discolouration of urine (dark yellow or yellow-green) – this is harmless
- Severe skin reactions (blistering, skin redness, itching)
- Elevated blood sugar levels – diabetic patients may need dose adjustments to their diabetes medications
- Blood clots (thromboembolism)
QT prolongation: Changes in the electrical activity of the heart (QT prolongation on ECG) have been reported with flutamide use. This is particularly relevant for patients taking other medications known to prolong the QT interval (see Drug Interactions section above).
Jaundice (yellowing of skin or eyes), dark-coloured urine, persistent loss of appetite, yellowing of the whites of the eyes, tenderness in the upper right abdomen, or flu-like symptoms. These may be signs of serious liver damage. Also seek immediate help for severe difficulty breathing, blistering skin reactions, or signs of blood clots (sudden chest pain, shortness of breath, or leg swelling).
How Should You Store Flutamid STADA?
Flutamid STADA has no special storage requirements. Store at room temperature, keep out of the sight and reach of children, and do not use after the expiry date printed on the packaging.
This medicine does not require any special storage conditions. Keep it in the original packaging to protect from light and moisture. Store the tablets at room temperature (below 25°C / 77°F). Do not store in the bathroom or other areas with high humidity.
Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of the stated month. Check the expiry date each time you take your medicine.
Keep this medicine out of the sight and reach of children. Do not dispose of medicines by flushing them down the toilet or putting them in household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures help to protect the environment and prevent accidental exposure.
What Does Flutamid STADA Contain?
Each Flutamid STADA tablet contains 250 mg of flutamide as the active substance, along with several inactive ingredients (excipients) that help form the tablet.
Active Ingredient
Each tablet contains 250 mg flutamide. Flutamide is a nonsteroidal antiandrogen with the chemical name 2-methyl-N-[4-nitro-3-(trifluoromethyl)phenyl]propanamide.
Inactive Ingredients (Excipients)
The other ingredients are:
- Microcrystalline cellulose – a plant-derived fibre used as a tablet filler and binder
- Maize starch – used as a disintegrant to help the tablet break down in the digestive tract
- Sodium lauryl sulfate – a surfactant that aids in drug dissolution
- Lactose monohydrate – a sugar used as a filler (see section on excipients above if you have lactose intolerance)
- Colloidal anhydrous silica – used as a flow agent during manufacturing
- Magnesium stearate – a lubricant that prevents the tablet from sticking to manufacturing equipment
Appearance and Pack Sizes
Flutamid STADA tablets are pale yellow, round tablets. They are available in pack sizes of 21, 50, 84, 90, 100, 105, or 200 tablets. Not all pack sizes may be available in your country.
Frequently Asked Questions About Flutamid STADA
Flutamide (brand name Flutamid STADA) is a nonsteroidal antiandrogen used in the treatment of prostate cancer. It works by blocking the effects of male sex hormones (androgens) on prostate cancer cells, thereby slowing or stopping tumour growth. Flutamide is prescribed either as monotherapy, in combination with LHRH agonists (such as goserelin or leuprolide) for combined androgen blockade, or in men who have undergone surgical castration. It is a prescription-only medication that must be used under close medical supervision.
The most serious risk associated with flutamide is hepatotoxicity (liver damage). In rare cases, flutamide has caused fatal liver failure. Warning signs include jaundice (yellowing of skin and eyes), dark urine, loss of appetite, upper right abdominal pain, nausea, vomiting, and flu-like symptoms. Regular liver function blood tests are mandatory during treatment. If any liver-related symptoms develop, treatment must be stopped immediately and medical attention sought. Additionally, flutamide may cause QT prolongation (a heart rhythm abnormality), especially when combined with other QT-prolonging medications.
The standard dose is one 250 mg tablet taken three times daily at approximately eight-hour intervals (for example, at 6:00 AM, 2:00 PM, and 10:00 PM). Tablets should be swallowed whole with a glass of water, preferably after meals to reduce gastrointestinal side effects. Continue taking the medication as prescribed by your doctor, even if you feel well. Do not stop or change the dose without consulting your healthcare provider, as interrupting antiandrogen therapy may allow cancer progression.
Yes. Flutamide can enhance the effect of anticoagulant (blood-thinning) medications such as warfarin, potentially increasing the risk of bleeding. If you are taking an anticoagulant, your doctor will likely need to monitor your blood clotting levels (INR) more frequently and may adjust the anticoagulant dose accordingly. Always inform your doctor about all medications you are taking before starting flutamide.
No. Flutamide is contraindicated in women. This medication is designed exclusively for the treatment of prostate cancer in men. It blocks the effects of male hormones and is not approved or safe for use in women. Men taking flutamide should use appropriate contraception (condoms) during treatment to prevent potential exposure of female partners to the drug through seminal fluid.
Regular liver function blood tests are mandatory throughout flutamide treatment. Your doctor will typically check liver enzymes (ALT, AST) and bilirubin levels before starting treatment, monthly during the first four months, and at regular intervals thereafter. If liver enzyme levels rise significantly (more than two to three times the upper limit of normal), your doctor may need to reduce the dose or stop treatment entirely. You should also report any symptoms that might indicate liver problems – such as jaundice, dark urine, persistent fatigue, or abdominal pain – to your doctor immediately.
References
This article is based on the following peer-reviewed sources and international guidelines:
- European Association of Urology (EAU). EAU Guidelines on Prostate Cancer. 2024 Edition. Available at: uroweb.org
- American Urological Association (AUA). Clinically Localized Prostate Cancer: AUA/ASTRO Guideline. 2022 (Amended 2023).
- National Institute for Health and Care Excellence (NICE). Prostate Cancer: Diagnosis and Management (NG131). Updated 2024.
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd List. 2023.
- Brogden RN, Clissold SP. Flutamide: A preliminary review of its pharmacodynamic and pharmacokinetic properties, and therapeutic efficacy in advanced prostatic cancer. Drugs. 1989;38(2):185-203. doi:10.2165/00003495-198938020-00003
- Labrie F, Dupont A, Belanger A, et al. New hormonal therapy in prostatic carcinoma: combined treatment with an LHRH agonist and an antiandrogen. Clinical and Investigative Medicine. 1982;5(4):267-275.
- European Medicines Agency (EMA). Summary of Product Characteristics: Flutamide. Last updated 2023.
- British National Formulary (BNF). Flutamide – Indications, Dosage, Side Effects. 2024 Edition.
- Mottet N, van den Bergh RCN, Briers E, et al. EAU-EANM-ESTRO-ESUR-SIOG Guidelines on Prostate Cancer – 2023 Update. European Urology. 2023;79(2):243-262.
- US Food and Drug Administration (FDA). FDA Drug Safety Communication: Flutamide Hepatotoxicity. Available at: fda.gov
About Our Medical Editorial Team
This article has been developed by the iMedic Medical Editorial Team, comprising board-certified specialists in oncology, urology, and clinical pharmacology. Our team follows the GRADE evidence framework and adheres to international editorial standards for medical content.
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Last reviewed: | Evidence level: 1A (Systematic reviews and RCTs) | Next review due: