Note: This document contains side effect information about elacestrant. Some dosage forms listed on this page may not apply to the brand name Orserdu.

Applies to elacestrant: oral tablet.

Serious side effects of Orserdu

Along with its needed effects, elacestrant (the active ingredient contained in Orserdu) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Other side effects of Orserdu

Some side effects of elacestrant may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Acid or sour stomach
• belching
• constipation
• decreased appetite
• diarrhea
• headache
• heartburn
• hot flush
• indigestion
• muscle or bone pain
• nausea
• stomach discomfort, upset, or pain
• unusual tiredness or weakness
• vomiting

For Healthcare Professionals

Applies to elacestrant: oral tablet.

General

Very common adverse reactions (>10%) included 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.^[Ref]

Cardiovascular

Very common (10% or more): Hot flushes (11%)

Frequency not reported: Cardiac arrest, septic shock^[Ref]

Dermatologic

Frequency not reported: Rash^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (35%), vomiting (19%), diarrhea (13%), constipation (12%), abdominal pain (11%), dyspepsia (10%)

Frequency not reported: Diverticulitis, stomatitis, gastroesophageal reflux disease^[Ref]

Hematologic

Very common (10% or more): Decreased hemoglobin (26%)^[Ref]

Musculoskeletal

Very common (10% or more): Musculoskeletal pain (41%)^[Ref]

Metabolic

Very common (10% or more): Increased cholesterol (30%), increased triglycerides (27%), hyponatremia (16%), decreased appetite (15%)^[Ref]

Psychiatric

Frequency not reported: Insomnia^[Ref]

Hepatic

Very common (10% or more): Increased aspartate aminotransferase (29%), increased alanine aminotransferase (17%)^[Ref]

Respiratory

Frequency not reported: Dyspnea, cough^[Ref]

Other

Very common (10% or more): Fatigue (26%)^[Ref]

Nervous system

Very common (10% or more): Headache (12%)

Frequency not reported: Dizziness^[Ref]

Renal

Very common (10% or more): Increased creatinine (16%)^[Ref]