OpenClaim

Elacestrant Side Effects

The most commonly reported side effects of elacestrant include nausea, fatigue, and disease progression, based on 7,015 FDA adverse event reports from 2018 to 2025. 6.9% of reports found the drug to be ineffective.

Elacestrant side effects

Percentages show how often each reaction appears relative to total reports for elacestrant.

1
Nausea21.0%1,475
2
Fatigue15.7%1,099
3
Disease Progression11.1%779
4
Vomiting9.5%668
5
Diarrhoea7.8%548
6
Death7.2%507
7
Drug Ineffective6.9%483
8
Constipation5.6%392
9
Product Dose Omission Issue5.3%372
10
Decreased Appetite5.3%369
11
Pain5.2%367
12
Arthralgia4.7%331
13
Asthenia3.4%241
14
Abdominal Discomfort3.3%233
15
Dyspepsia3.3%232

These are voluntary reports and do not establish that elacestrant caused these reactions.

Report severity

32.6%Serious2,284 reports
12.2%Hospitalizations859 reports
7.6%Fatal534 reports

Seriousness is determined by the reporter, not by OpenClaim.

Elacestrant drug interactions

Other drugs that appear in adverse event reports alongside elacestrant. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Palbociclib0.5%33
2
Abemaciclib0.3%18
3
Denosumab0.2%15
4
Capivasertib0.2%15
5
Alpelisib0.2%12
6
Everolimus0.2%12
7
Capecitabine0.2%11
8
Trastuzumab0.1%10
9
Fulvestrant0.1%9
10
Ondansetron0.1%8
11
Letrozole<0.1%7
12
Ribociclib<0.1%6
13
Paclitaxel<0.1%4
14
Ibuprofen<0.1%4
15
Zanubrutinib<0.1%4

Taken alongside

1
Ondansetron17.6%1,232
2
Ergocalciferol17.5%1,231
3
Acetaminophen15.0%1,053
4
Prochlorperazine8.4%588
5
Levothyroxine-sodium7.9%554
6
Gabapentin7.5%529
7
Calcium7.4%517
8
Oxycodone7.3%513
9
Metoprolol6.7%473
10
Cyanocobalamin6.4%449
11
Omeprazole5.9%414
12
Ibuprofen5.9%412
13
Denosumab5.7%400
14
Atorvastatin-calcium5.7%399
15
Amlodipine5.5%387

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports elacestrant side effects

90.2% of elacestrant adverse event reports involve female patients and 0.9% involve male patients. The largest age group is elderly at 54%. These figures reflect who reports side effects, not underlying risk.

Sex

Female90.2%
Male0.9%
Unknown9.0%

Age group

< 20.0%
2–110.0%
12–170.0%
18–6445.7%
65+54.3%

What is elacestrant used for

Conditions and purposes for which patients were taking elacestrant when the adverse event was reported.

Breast CancerBasal Cell CarcinomaBlastic Plasmacytoid Dendritic Cell NeoplasiaBone CancerBrain NeoplasmBreast CancerBreast Cancer FemaleBreast Cancer MaleBreast Cancer MetastaticBreast Cancer Stage IiiBreast Cancer Stage IvClinical Trial ParticipantEndometrial CancerGastrointestinal Stromal TumourHer2 Negative Breast Cancer

Showing 15 of 37 indications

Elacestrant brand names and reporting trend

Elacestrant is sold under the brand name Orserdu.

Brand names

Orserdu130

Quarterly reports (20182025)

201820242025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking elacestrant with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.