What the label lists and what reports show
Darolutamide side effects
Darolutamide's FDA label: “The most common adverse reactions (>10% with a ≥2% increase over placebo), including laboratory test abnormalities, are increased AST, decreased neutrophil count, increased bilirubin, fatigue, and increased ALT.” FAERS holds 5,501 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 (829 reports).
- No generic listed
Check it at the source: the darolutamide FDA label on DailyMed (effective June 3, 2025, Bayer HealthCare Pharmaceuticals 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 NUBEQA?NUBEQA may cause serious side effects, including: Heart disease. Blockage of the arteries in the heart (ischemic heart disease) that can lead to death has happened in some people during treatment with NUBEQA. Your healthcare provider will monitor you for signs and symptoms of heart problems during your treatment with NUBEQA. Call your healthcare provider or get medical help right away if you get chest pain or discomfort at rest or with activity, or shortness of breath during your treatment with NUBEQA. Seizure. Treatment with NUBEQA may increase your risk of having a seizure. You should avoid activities where a sudden loss of consciousness could cause serious harm to yourself or others. Tell your healthcare provider right away if you have loss of consciousness or seizure during treatment with NUBEQA. […]
Source: FDA drug label, Bayer HealthCare Pharmaceuticals Inc., effective June 3, 2025 (SPL set 1a7cb212-56e4-4b9d-a73d-bfee7fe4735e), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (>10% with a ≥2% increase over placebo), including laboratory test abnormalities, are increased AST, decreased neutrophil count, increased bilirubin, fatigue, and increased ALT.
Table 5: Adverse Reactions (≥10% with a ≥2% increase compared to placebo with docetaxel) in ARASENS
| Reaction | All Grades % | Grades 3 or 4 % | All Grades % | Grades 3 or 4 % |
|---|---|---|---|---|
| Constipation | 23 | 0.3 | 20 | 0.3 |
| Rash Rash includes rash, rash maculo-papular, palmar-plantar erythrodysesthesia syndrome,… | 20 | 1.8 | 15 | 0.2 |
| Decreased Appetite | 19 | 0.2 | 13 | 0.6 |
| Hemorrhage Hemorrhage includes hematuria, epistaxis, anal hemorrhage, hemorrhoidal… | 18 | 1.4 | 13 | 1.4 |
| Weight Increased | 18 | 2.1 | 16 | 1.2 |
| Hypertension Hypertension includes hypertension, blood pressure increased, hypertensive… | 14 | 7 | 10 | 3.6 |
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, continuedIn nmCRPC and mCSPC : The most common adverse reactions (>10% with a ≥2% increase over placebo), including laboratory test abnormalities, are increased AST, decreased neutrophil count, increased bilirubin, fatigue, and increased ALT. ( 6.1 ) In mCSPC in combination with docetaxel: The most common adverse reactions (≥10% with a ≥2% increase over placebo) are constipation, rash, decreased appetite, hemorrhage, increased weight, and hypertension. The most common laboratory test abnormalities (≥30%) are anemia, hyperglycemia, decreased lymphocyte count, decreased neutrophil count, increased AST, increased ALT, and hypocalcemia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bayer HealthCare Pharmaceuticals Inc. at 1-888-842-2937 or FDA at 1-800-FDA-1088 or WWW.FDA.GOV/MEDWATCH. 6.1 Clinical Trials Experience 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. The pooled data in WARNINGS and PRECAUTIONS reflect two randomized clinical trials [ARAMIS, ARANOTE] in patients with nmCRPC (N = 954) and mCSPC (N = 445) treated with NUBEQA. …
Source: FDA drug label, Bayer HealthCare Pharmaceuticals Inc., effective June 3, 2025 (SPL set 1a7cb212-56e4-4b9d-a73d-bfee7fe4735e), via openFDA; the full label on DailyMed
What do FAERS reports show?
5,501 reports list darolutamide among the medicines taken, each a report of something that happened, not proof the medicine caused it; 670 are coded as a death and 1,200 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. Reports rose sharply in 2025 (1,986, against a median of 152 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 20 reactions below, 8 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?
- Darolutamide: 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