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Eulexin

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Eulexin

Eulexin

Eulexin Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Eulexin (flutamide) Capsules is an antiandrogen used to treat prostate cancer. It is available in generic form. Common side effects of Eulexin include hot flashes, loss of sexual interest, diarrhea, nausea, vomiting, and enlargement of male breasts.

The recommended dosage of Eulexin is 2 capsules, 3 times a day at 8-hour intervals. Warfarin may interact with Eulexin. Before taking Eulexin your doctor will monitor your liver function. Eulexin is not indicated for women of child bearing age, therefore you should not take Eulexin if you are pregnant or breastfeeding.

Our Eulexin (flutamide) Capsules Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Eulexin in Detail - Patient Information: Side Effects

Stop taking flutamide 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. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Eulexin (Flutamide) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Eulexin Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning section.

Because flutamide is usually used with other medications, the side effects may be caused by the other medications or their combination. Hot flashes, loss of sexual interest/ability, diarrhea, nausea, vomiting, and enlargement of male breasts may occur. Less common side effects include drowsiness. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Diarrhea is a common side effect. Drink plenty of fluids as directed by your doctor to reduce your risk of losing too much body water. You may decrease dairy products, increase whole grains/vegetables/fruit, and stop any laxatives. Your doctor may prescribe anti-diarrhea medication (such as loperamide) to control your symptoms. Tell your doctor immediately if you develop severe or persistent diarrhea or signs of dehydration (such as dizziness, decreased amount of urine).

Flutamide may change the color of your urine to light orange-brown or yellow-green. This is not harmful.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these rare but very serious side effects occur: mental/mood changes (such as depression, anxiety, nervousness), a breast lump, confusion, sudden severe tiredness, weakness, pale skin, bluish fingernails/lips/skin, fast heartbeat at rest, feeling short of breath at rest.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Eulexin (Flutamide)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Eulexin FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Stage B2-C Prostatic Carcinoma

Treatment with EULEXIN (flutamide) Capsules and the LHRH agonist did not add substantially to the toxicity of radiation treatment alone. The following adverse experiences were reported during a multicenter clinical trial comparing EULEXIN (flutamide) Capsules + LHRH-A +radiation versus radiation alone. The most frequently reported (greater than 5%) adverse experiences are listed below.

Adverse Events During Acute Radiation Therapy
(within first 90 days of radiation therapy)

 

(n= 231)
LHRH -A +
EULEXIN (flutamide) Capsules +
Radiation
% All

(n= 235)
Radiation
Only
 
% All

Rectum/Large Bowel

80

76

Bladder

58

60

Skin

37

37

Adverse Events During Late Radiation Phase
(after 90 days of radiation therapy)

 

(n= 231)
LHRH-A +
EULEXlN Capsules +
Radiation
%All

(n= 235)
Radiation
Only
 
%All

Diarrhea

36

40

Cystitis

16

16

Rectal Bleeding

14

20

Proctitis

8

8

Hematuria

7

12


Additional adverse event data was collected for the combination therapy with radiation group over both the hormonal treatment and hormonal treatment plus radiation phases of the study. Adverse experiences occurring in more than 5% of patients in this group, over both parts of the study, were hot flashes (46%), diarrhea (40%), nausea (9%), and skin rash (8%).

Stage D2 Metastatic Carcinoma

The following adverse experiences were reported during a multi-center clinical trial comparing EULEXIN (flutamide) Capsules + LHRH agonist versus placebo + LHRH agonist.

The most frequently reported (greater than 5%) adverse experiences during treatment with EULEXIN (flutamide) Capsules in combination with an LHRH agonist are listed in the table below. For comparison, adverse experiences seen with an LHRH agonist and placebo are also listed in the following table.

 

(n= 294)
Flutamide +
LHRH
agonist
%All

(n= 285)
Placebo +
LHRA
agonist
%All

Hot Flashes

61

57

Loss of Libido

36

31

Impotence

33

29

Diarrhea

12

4

Nausea/ Vomiting

11

10

Gynecomastia

9

11

Other

7

9

Other GI

6

4


 As shown in the table, for both treatment groups, the most frequently occurring adverse experiences (hot flashes, impotence, loss of libido) were those known to be associated with low serum androgen levels and known to occur with LHRH agonists alone.

The only notable difference was the higher incidence of diarrhea in the flutamide + LHRH agonist group (12%), which was severe in 5% as opposed to the placebo + LHRH agonist (4%), which was severe in less than1%.

In addition, the following adverse reactions were reported during treatment with flutamide + LHRH agonist. No causal relatedness of these reactions to drug treatment has been made, and some of the adverse experiences reported are those that commonly occur in elderly patients.

Cardiovascular System: hypertension in 1% of patients.

Central Nervous System: CNS (drowsiness/confusion/depression/anxiety/nervousness) reactions occurred in 1% of patients.

Gastrointestinal System: anorexia 4%, and other GI disorders occurred in 6% of patients.

Hematopoietic System: anemia occurred in 6%, leukopenia in 3%, and thrombocytopenia in 1% of patients.

Liver and Biliary System: hepatitis and jaundice in less than 1% of patients.

Skin: irritation at the injection site and rash occurred in 3% of patients.

Other: edema occurred in 4%, genitourinary and neuromuscular symptoms in 2%, and pulmonary symptoms in less than 1% of patients.

In addition, the following spontaneous adverse experiences have been reported during the marketing of flutamide: hemolytic anemia, macrocytic anemia, methemoglobinemia, photosensitivity reactions (including erythema, ulceration, bullous eruptions, and epidermal necrolysis), and urine discoloration. The urine was noted to change to an amber or yellow-green appearance which can be attributed to the flutamide and/or its metabolites. Also reported were cholestatic jaundice, hepatic encephalopathy, and hepatic necrosis. The hepatic conditions were usually reversible after discontinuing therapy; however, there have been reports of death following severe hepatic injury associated with use of flutamide.

Malignant breast neoplasms have occured in male patients being treated with EULEXIN (flutamide) Capsules.

Abnormal Laboratory Test Values: Laboratory abnormalities including elevated SGOT, SGPT, bilirubin values, SGGT, BUN, and serum creatinine have been reported.

Read the entire FDA prescribing information for Eulexin (Flutamide) »

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Eulexin - User Reviews

Eulexin User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Eulexin sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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