What the label lists and what reports show
Apalutamide side effects
Apalutamide's FDA label: “The most common adverse reactions (≥10%) are fatigue, arthralgia, rash, decreased appetite, fall, weight decreased, hypertension, hot flush, diarrhea, and fracture.” FAERS holds 11,688 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 rash (1,285 reports).
- No generic listed
Check it at the source: the apalutamide FDA label on DailyMed (effective July 2, 2026, Janssen Products, LP); 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 ERLEADA?ERLEADA may cause serious side effects including: Heart disease, stroke, or mini-stroke. Bleeding in the brain or blockage of the arteries in the heart or in part of the brain have happened in some people during treatment with ERLEADA and can lead to death. Your healthcare provider will monitor you for signs and symptoms of heart or brain problems during your treatment with ERLEADA. Call your healthcare provider or get medical help right away if you get: chest pain or discomfort at rest or with activity shortness of breath numbness or weakness of the face, arm, or leg, especially on one side of the body trouble talking or understanding trouble seeing in one or both eyes dizziness, loss of balance or coordination, or trouble walking Fractures and falls. ERLEADA treatment can cause bones and muscles to weaken and may increase your risk for falls and fractures. […]
Source: FDA drug label, Janssen Products, LP, effective July 2, 2026 (SPL set d1cda4f7-cb33-46ea-b9ac-431f6452b1a5), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (≥10%) are fatigue, arthralgia, rash, decreased appetite, fall, weight decreased, hypertension, hot flush, diarrhea, and fracture.
Table 3: Adverse Reactions in SPARTAN (nmCRPC)
| System/Organ Class Adverse reaction | All Grades % | Grade 3–4 % | All Grades % | Grade 3–4 % |
|---|---|---|---|---|
| Fatigue Includes fatigue and asthenia. , Per the Common Terminology Criteria for Adverse… | 39 | 1.4 | 28 | 0.3 |
| Arthralgia | 16 | 0 | 8 | 0 |
| Rash Includes rash, rash maculo-papular, rash generalized, urticaria, rash pruritic, rash… | 25 | 5.2 | 6 | 0.3 |
| Decreased appetite Includes appetite disorder, decreased appetite, early satiety, and… | 12 | 0.1 | 9 | 0 |
| Peripheral edema Includes peripheral edema, generalized edema, edema, edema genital,… | 11 | 0 | 9 | 0 |
| Fall | 16 | 1.7 | 9 | 0.8 |
| Fracture Includes rib fracture, lumbar vertebral fracture, spinal compression fracture,… | 12 | 2.7 | 7 | 0.8 |
| Weight decreased | 16 | 1.1 | 6 | 0.3 |
| Hypertension | 25 | 14 | 20 | 12 |
| Hot flush | 14 | 0 | 9 | 0 |
| Diarrhea | 20 | 1.1 | 15 | 0.5 |
| Nausea | 18 | 0 | 16 | 0 |
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, continuedThe following are discussed in more detail in other sections of the labeling: Cerebrovascular and Ischemic Cardiovascular Events [see Warnings and Precautions (5.1) ]. Fractures [see Warnings and Precautions (5.2) ]. Falls [see Warnings and Precautions (5.3) ]. Seizure [see Warnings and Precautions (5.4) ]. Severe Cutaneous Adverse Reactions (SCARs) [see Warnings and Precautions (5.5) ]. Interstitial Lung Disease (ILD) [see Warnings and Precautions (5.6) ]. The most common adverse reactions (≥10%) are fatigue, arthralgia, rash, decreased appetite, fall, weight decreased, hypertension, hot flush, diarrhea, and fracture. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Janssen Products, LP at 1-800-526-7736 (1-800-JANSSEN) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial 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. …
Source: FDA drug label, Janssen Products, LP, effective July 2, 2026 (SPL set d1cda4f7-cb33-46ea-b9ac-431f6452b1a5), via openFDA; the full label on DailyMed
What do FAERS reports show?
11,688 reports list apalutamide among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,506 are coded as a death and 2,607 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 18 reactions below, 12 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?
- Apalutamide: 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