What the label lists and what reports show
Flutamide side effects
Flutamide's FDA label: “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) Goserelin Acetate Implant + Eulexin ® + Radiation (n=235) Radiation Only % …” FAERS holds 985 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is prostate cancer (70 reports).
- Generic listed
- Boxed warning
Check it at the source: the flutamide FDA label on DailyMed (effective February 4, 2025, Waylis Therapeutics LLC); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the other possible side effects of taking Eulexin ® capsules?In a medical study, when Eulexin ® capsules were taken together with an LHRH agonist, the most common side effects were hot flashes, loss of sex drive (libido) and impotence. In addition, some men had diarrhea, nausea or vomiting, and breast enlargement. In another medical study, when the Eulexin ® product was taken together with goserelin acetate (an LHRH agonist) and radiation therapy, the side effects of Eulexin ® therapy were about the same as when radiation therapy was given alone. These included hot flashes, diarrhea, nausea and skin rash. What can I do if I get diarrhea? If you experience moderate diarrhea due to Eulexin ® capsules, the following advice may help: drink plenty of fluids reduce your intake of dairy products (for example, milk, cheese, yogurt). Increase your intake of whole grains, fruits and vegetables. Stop laxative use. Take nonprescription antidiarrheal medicines. […]
Source: FDA drug label, Waylis Therapeutics LLC, effective February 4, 2025 (SPL set 0a905e25-42b6-4937-a689-f01a8f22e644), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe 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) Goserelin Acetate Implant + Eulexin ® + Radiation (n=235) Radiation Only % All % 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) Goserelin Acetate Implant + Eulexin ® + Radiation (n=235) […]
Adverse Events During Late Radiation Phase (after 90 days of radiation therapy)
| Reaction | (n=231) Goserelin Acetate Implant + Eulexin ® + Radiation % All | (n=235) Radiation Only % All |
|---|---|---|
| Diarrhea | 36 | 40 |
| Cystitis | 16 | 16 |
| Rectal Bleeding | 14 | 20 |
| Proctitis | 8 | 8 |
| Hematuria | 7 | 12 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedStage B 2 -C Prostatic Carcinoma Treatment with Eulexin ® capsules and the goserelin acetate implant did not add substantially to the toxicity of radiation treatment alone. The following adverse experiences were reported during a multicenter clinical trial comparing Eulexin ® + goserelin acetate implant + 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) Goserelin Acetate Implant + Eulexin ® + Radiation (n=235) Radiation Only % All % 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) Goserelin Acetate Implant + Eulexin ® + Radiation (n=235) Radiation Only % All % All Diarrhea 36 40 Cystitis 16 16 Rectal Bleeding 14 20 Proctitis 8 8 Hematuria 7 12 Additional adverse event data were 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%). …
Source: FDA drug label, Waylis Therapeutics LLC, effective February 4, 2025 (SPL set 0a905e25-42b6-4937-a689-f01a8f22e644), via openFDA; the full label on DailyMed
What do FAERS reports show?
985 reports list flutamide among the medicines taken, each a report of something that happened, not proof the medicine caused it; 250 are coded as a death and 356 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 6 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Flutamide: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions