Elacestrant: uses, dosing, side effects & brands
Elacestrant is an estrogen receptor antagonist sold in the U.S. under one brand. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Estrogen Receptor Antagonist
- Available as
- Tablet
- Sold as
- Orserdu
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How elacestrant is dosed
From the FDA label for Orserdu (application NDA217639). Other elacestrant products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Select patients for treatment with ORSERDU based on the presence of ESR1 mutations. ( 2.1 ) The recommended dosage of ORSERDU is one 345 mg tablet taken orally, once daily, with food ( 2.2 ) Dose interruption, reduction, or permanent discontinuation may be required due to adverse reactions. ( 2.3 ) 2.1 Patient Selection Select patients for treatment of ER-positive, HER2-negative advanced or metastatic breast cancer with ORSERDU based on the presence of ESR1 mutation(s) in plasma specimen using an FDA-authorized test [see Indications and Usage ( 1 ) and Clinical Studies ( 14 )] . Information on FDA-authorized tests for detection of ESR1 mutations in breast cancer is available at: http://www.fda.gov/CompanionDiagnostics. 2.2 Recommended Dosage The recommended dosage of ORSERDU is 345 mg taken orally with food once daily until disease progression or unacceptable toxicity occurs. Take ORSERDU at approximately the same time each day. Take with food to reduce nausea and vomiting [see Adverse Reactions ( 6.1 )] . Swallow ORSERDU tablet(s) whole. Do not chew, crush, or split prior to swallowing. Do not take any ORSERDU tablets that are broken, cracked, or that look damaged. If a dose is missed for more than 6 hours or vomiting occurs, skip the dose and take the next dose the following day at its regularly scheduled time. 2.3 Dosage Modifications for Adverse Reactions The recommended…
Elacestrant side effects
The following clinically significant adverse reactions are described elsewhere in the labeling: Dyslipidemia [see Warnings and Precautions ( 5.1 )] The most common (>10%) adverse reactions, including laboratory abnormalities, of ORSERDU were musculoskeletal pain, nausea, increased cholesterol, increased AST, increased triglycerides, fatigue, decreased hemoglobin, vomiting, increased ALT, decreased sodium, increased creatinine, decreased appetite, diarrhea, headache, constipation, abdominal pain, hot flush, and dyspepsia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Stemline Therapeutics, Inc. at 1-877-332-7961 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 safety of ORSERDU was evaluated in 467 patients with ER+/HER2- advanced breast cancer following CDK4/6 inhibitor therapy in EMERALD, a randomized, open-label, multicenter study [see Clinical Studies ( 14 )] . Patients received ORSERDU 345 mg orally once daily (n=237) or standard of care (SOC) consisting of fulvestrant or an aromatase inhibitor (n=230). Among patients who received ORSERDU, 22% were exposed for 6 months…
Who shouldn’t take elacestrant
None. None ( 4 )
Elacestrant drug interactions
Strong and Moderate CYP3A4 Inducers : Avoid concomitant use. ( 7.1 ) Strong and Moderate CYP3A4 Inhibitors : Avoid concomitant use. ( 7.1 ) 7.1 Effect of Other Drugs on ORSERDU Strong and Moderate CYP3A4 Inhibitors Avoid concomitant use of strong or moderate CYP3A inhibitors with ORSERDU. Elacestrant is a CYP3A4 substrate. Concomitant use of a strong or moderate CYP3A4 inhibitor increase elacestrant exposure [see Clinical Pharmacology ( 12.3 )] , which may increase the risk of adverse reactions of ORSERDU. Strong and Moderate CYP3A4 Inducers Avoid concomitant use of strong or moderate CYP3A inducers with ORSERDU. Elacestrant is a CYP3A4 substrate. Concomitant use of a strong or moderate CYP3A4 inducer decreases elacestrant exposure [see Clinical Pharmacology ( 12.3 )] , which may decrease effectiveness of ORSERDU. 7.2 Effect of ORSERDU on Other Drugs P-gp Substrates Reduce the dosage of P-gp substrates per their Prescribing Information when minimal concentration changes may lead to serious or life-threatening adverse reactions. Elacestrant is a P-gp inhibitor. Concomitant use of ORSERDU with a P-gp substrate increased the concentrations of P-gp substrate [see Clinical Pharmacology ( 12.3 )] , which may increase the adverse reactions associated with a P-gp substrate. BCRP Substrates Reduce the dosage of BCRP substrates per their Prescribing Information when minimal concentration changes may lead to serious or life-threatening adverse reactions. Elacestrant is a BCRP inhibitor. Concomitant use of ORSERDU with a BCRP substrate increased the plasma concentrations of BCRP substrate [see Clinical Pharmacology ( 12.3 )] , which may increase the adverse reactions associated with a BCRP substrate.
Every elacestrant product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Orserdu.
Can you crush or split elacestrant?
At least one elacestrantproduct is labelled to be swallowed whole — crushing an extended-release tablet releases the whole day’s dose at once. Which applies depends on the form you were given.
What each elacestrant label says about crushing, splitting and chewingRelated calculators
Frequently asked questions
What is elacestrant?
Orserdu (Elacestrant Hydrochloride) is an estrogen receptor antagonist.
What kind of drug is elacestrant?
The FDA classifies elacestrant as an estrogen receptor antagonist. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take elacestrant with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run elacestrant against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does elacestrant come in?
Across the brands we track, elacestrant is currently marketed as tablet, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic elacestrant?
We do not currently list a generic-labelled elacestrant product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Elacestrant: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/elacestrant
- MLA
- “Elacestrant: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/elacestrant.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for elacestrant on DailyMed (NIH) ↗.