ELACESTRANT

N/A

Manufactured by Stemline Therapeutics, Inc.

14,750 FDA adverse event reports analyzed

Last updated: 2026-04-15

About ELACESTRANT

ELACESTRANT is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Stemline Therapeutics, Inc.. The most commonly reported adverse reactions for ELACESTRANT include NAUSEA, FATIGUE, DISEASE PROGRESSION, VOMITING, DIARRHOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ELACESTRANT.

Top Adverse Reactions

NAUSEA1,475 reports
FATIGUE1,099 reports
DISEASE PROGRESSION779 reports
VOMITING668 reports
DIARRHOEA548 reports
DEATH507 reports
DRUG INEFFECTIVE482 reports
CONSTIPATION392 reports
PRODUCT DOSE OMISSION ISSUE372 reports
DECREASED APPETITE369 reports
PAIN367 reports
ARTHRALGIA331 reports
ASTHENIA241 reports
ABDOMINAL DISCOMFORT233 reports
DYSPEPSIA232 reports
HEADACHE226 reports
TUMOUR MARKER INCREASED224 reports
MYALGIA210 reports
HOT FLUSH191 reports
ABDOMINAL PAIN UPPER175 reports
BONE PAIN162 reports
DIZZINESS161 reports
ILLNESS161 reports
MALAISE150 reports
BACK PAIN148 reports
MALIGNANT NEOPLASM PROGRESSION139 reports
RASH138 reports
PAIN IN EXTREMITY133 reports
DYSPNOEA128 reports
BLOOD CHOLESTEROL INCREASED127 reports
COUGH127 reports
WEIGHT DECREASED120 reports
URINARY TRACT INFECTION113 reports
ALOPECIA108 reports
GASTROOESOPHAGEAL REFLUX DISEASE105 reports
DEHYDRATION100 reports
HOSPITALISATION100 reports
PRODUCT DOSE OMISSION IN ERROR95 reports
PRURITUS93 reports
FALL92 reports
PRODUCT USE COMPLAINT91 reports
ABDOMINAL PAIN89 reports
NASOPHARYNGITIS89 reports
PNEUMONIA88 reports
COVID 1987 reports
PERIPHERAL SWELLING87 reports
DYSPHAGIA83 reports
ADVERSE DRUG REACTION82 reports
INSOMNIA80 reports
MUSCLE SPASMS79 reports
SOMNOLENCE79 reports
NEOPLASM PROGRESSION77 reports
FEELING ABNORMAL75 reports
ABDOMINAL DISTENSION71 reports
FOREIGN BODY IN THROAT69 reports
HOSPICE CARE69 reports
DRUG INTOLERANCE64 reports
CHEST PAIN62 reports
HEPATIC ENZYME INCREASED60 reports
PRODUCT SIZE ISSUE59 reports
FLATULENCE58 reports
METASTASES TO LIVER57 reports
METASTASES TO BONE56 reports
PYREXIA55 reports
GAIT DISTURBANCE49 reports
HAEMOGLOBIN DECREASED49 reports
NEUROPATHY PERIPHERAL49 reports
WHITE BLOOD CELL COUNT DECREASED46 reports
DRY MOUTH45 reports
MUSCULOSKELETAL PAIN45 reports
PLEURAL EFFUSION45 reports
THROAT IRRITATION44 reports
MUSCULAR WEAKNESS42 reports
PRODUCT USE ISSUE42 reports
DRY SKIN41 reports
ANXIETY40 reports
CONFUSIONAL STATE40 reports
HYPERSENSITIVITY40 reports
LABORATORY TEST ABNORMAL40 reports
WEIGHT INCREASED40 reports
BLOOD GLUCOSE INCREASED37 reports
MUSCULOSKELETAL CHEST PAIN37 reports
THERAPY CESSATION37 reports
OFF LABEL USE36 reports
OROPHARYNGEAL PAIN36 reports
THROMBOSIS36 reports
ANAEMIA35 reports
ADVERSE EVENT34 reports
GASTROINTESTINAL DISORDER34 reports
INFLUENZA34 reports
MEMORY IMPAIRMENT33 reports
DEPRESSION32 reports
DYSGEUSIA32 reports
URTICARIA32 reports
HYPOAESTHESIA31 reports
SLEEP DISORDER31 reports
UNDERDOSE31 reports
ASCITES30 reports
BLOOD POTASSIUM DECREASED29 reports
FEEDING DISORDER29 reports

Report Outcomes

Out of 7,013 classified reports for ELACESTRANT:

Serious 32.6%Non-Serious 67.4%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female6,325 (99.0%)
Male61 (1.0%)
Unknown1 (0.0%)

Reports by Age

Age 64244 reports
Age 70206 reports
Age 63203 reports
Age 66201 reports
Age 72201 reports
Age 62200 reports
Age 65198 reports
Age 67198 reports
Age 68194 reports
Age 60190 reports
Age 69187 reports
Age 74187 reports
Age 61185 reports
Age 71183 reports
Age 59181 reports
Age 75181 reports
Age 73167 reports
Age 57157 reports
Age 58154 reports
Age 77154 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with ELACESTRANT?

This profile reflects 14,750 FDA FAERS reports that mention ELACESTRANT. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ELACESTRANT?

Frequently reported terms in FAERS include NAUSEA, FATIGUE, DISEASE PROGRESSION, VOMITING, DIARRHOEA, DEATH. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ELACESTRANT?

Labeling and FAERS entries often list Stemline Therapeutics, Inc. in connection with ELACESTRANT. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.