Elacestrant: Side Effects, Uses & Monitoring
ORSERDU is indicated for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)‑negative, ESR1 -mutated advanced or metastatic breast canc
- Data source
- FDA labeling via NIH DailyMed (label aa66ae5c…)
- Label version
- current
- Last reviewed
- 2026
Reported adverse reactions
Reactions listed in current FDA labeling, with the highest frequency reported across summarized placebo-controlled trials.
No structured frequency data available in current labeling. Consult the official label.
Labeled uses (from FDA prescribing information)
ORSERDU is indicated for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)‑negative, ESR1 -mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test [see Dosage and Administration (2.1 )] , with disease progression following at least one line of endocrine therapy.
Conditions associated with Elacestrant in labeling
Frequently Asked Questions
What is Elacestrant used for?
FDA labeling lists the approved uses shown above under "Labeled uses." This summary is informational; only a qualified prescriber can determine whether a medication is appropriate for you.
What are the most commonly reported side effects of Elacestrant?
Current labeling for this ingredient does not include a structured frequency table that we can reproduce. Review the official label linked below.
Does Elacestrant require lab monitoring?
Monitoring needs vary. Ask your healthcare provider whether any lab tests apply while taking Elacestrant.
Where does this information come from?
All clinical facts on this page were extracted from the current FDA-registered product labeling for this ingredient, published by manufacturers through NIH DailyMed. See the source link below.
Medical disclaimer: Educational content extracted from public FDA labeling. Not medical advice. Always consult a qualified healthcare professional before starting, stopping, or changing any medication.