What the label lists and what reports show
Bicalutamide side effects
Bicalutamide's FDA label lists its adverse reactions in its own words. FAERS holds 15,152 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 fatigue (1,328 reports).
- Generic listed
Check it at the source: the bicalutamide FDA label on DailyMed (effective April 23, 2026, Golden State Medical Supply, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of bicalutamide tablets?Bicalutamide tablets may cause serious side effects, including: Liver problems. Severe liver problems, including liver failure that may need to be treated in a hospital or that may lead to death have happened in people who take bicalutamide tablets. Your healthcare provider should do blood tests to check your liver function before and during treatment with bicalutamide tablets. Tell your healthcare provider right away if you develop any of these symptoms of liver problems during treatment: yellowing of the skin and eyes (jaundice) dark urine right upper stomach pain nausea vomiting tiredness loss of appetite chills fever Bleeding problems. Serious bleeding problems have happened in people who take bicalutamide tablets in combination with a blood thinner medicine (coumarin anticoagulants). Bleeding problems have happened days to weeks after starting bicalutamide tablets treatment. […]
Source: FDA drug label, NDA020498 (Ani Pharms), as published by Golden State Medical Supply, Inc., effective April 23, 2026 (SPL set 26e30155-a50b-df14-e063-6394a90a9be4), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsADVERSE REACTIONS Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse reactions that occurred in more than 10% of patients receiving bicalutamide plus an LHRH-A were: hot flashes, pain (including general, back, pelvic and abdominal), asthenia, constipation, infection, nausea, peripheral edema, dyspnea, diarrhea, hematuria, nocturia, and anemia. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact ANI Pharmaceuticals, Inc. at 1-855-204-1431 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1. …
Table 1. Incidence of Adverse Reactions (≥ 5% in Either Treatment Group) Regardless of Causality
| Reaction | Body System Adverse Reaction Bicalutamide Plus LHRH Analog (n=401) | Treatment Group Number of Patients (%) Flutamide Plus LHRH Analog (n=407) |
|---|---|---|
| Pain (General) | 142 (35) | 127 (31) |
| Back Pain | 102 (25) | 105 (26) |
| Asthenia | 89 (22) | 87 (21) |
| Pelvic Pain | 85 (21) | 70 (17) |
| Infection | 71 (18) | 57 (14) |
| Abdominal Pain | 46 (11) | 46 (11) |
| Chest Pain | 34 (8) | 34 (8) |
| Headache | 29 (7) | 27 (7) |
| Flu Syndrome | 28 (7) | 30 (7) |
| Hot Flashes | 211 (53) | 217 (53) |
| Hypertension | 34 (8) | 29 (7) |
| Constipation | 87 (22) | 69 (17) |
| Nausea | 62 (15) | 58 (14) |
| Diarrhea | 49 (12) | 107 (26) |
| Increased Liver Enzyme Test | 30 (7) | 46 (11) |
| Dyspepsia | 30 (7) | 23 (6) |
| Flatulence | 26 (6) | 22 (5) |
| Anorexia | 25 (6) | 29 (7) |
| Vomiting | 24 (6) | 32 (8) |
| Anemia | 45 (11) | 53 (13) |
| Peripheral Edema | 53 (13) | 42 (10) |
| Weight Loss | 30 (7) | 39 (10) |
| Hyperglycemia | 26 (6) | 27 (7) |
| Alkaline Phosphatase Increased | 22 (5) | 24 (6) |
| Weight Gain | 22 (5) | 18 (4) |
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.
Source: FDA drug label, NDA020498 (Ani Pharms), as published by Golden State Medical Supply, Inc., effective April 23, 2026 (SPL set 26e30155-a50b-df14-e063-6394a90a9be4), via openFDA; the full label on DailyMed
What do FAERS reports show?
15,152 reports list bicalutamide among the medicines taken, each a report of something that happened, not proof the medicine caused it; 2,714 are coded as a death and 5,458 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 22 reactions below, 11 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?
- Bicalutamide: 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