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Luspatercept Side Effects

The most commonly reported side effects of luspatercept include death, off label use, and haemoglobin decreased, based on 2,209 FDA adverse event reports from 2018 to 2025. 4.0% of reports found the drug to be ineffective.

Luspatercept side effects

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

1
Death9.1%200
2
Off Label Use7.2%159
3
Haemoglobin Decreased6.0%132
4
Fatigue5.5%121
5
Drug Ineffective4.0%89
6
Weight Decreased3.7%81
7
Product Storage Error3.5%77
8
Dizziness3.4%75
9
Dyspnoea3.0%67
10
Fall2.8%61
11
Myelodysplastic Syndrome2.7%60
12
Asthenia2.2%49
13
Weight Increased2.1%47
14
Hypertension2.0%45
15
Bone Pain2.0%44

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

Report severity

60.3%Serious1,333 reports
21.3%Hospitalizations470 reports
15.5%Fatal343 reports

Seriousness is determined by the reporter, not by OpenClaim.

Luspatercept drug interactions

Other drugs that appear in adverse event reports alongside luspatercept. 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
Lenalidomide2.0%44
2
Deferiprone1.7%38
3
Ruxolitinib1.2%26
4
Deferasirox1.0%22
5
Azacitidine0.9%20
6
Pacritinib-citrate0.7%16
7
Nivolumab0.7%15
8
Epoetin0.5%12
9
Apixaban0.4%8
10
Venetoclax0.4%8
11
Darbepoetin-alfa0.4%8
12
Momelotinib-dihydrochloride0.4%8
13
Filgrastim0.3%7
14
Paclitaxel0.3%7
15
Acetaminophen0.3%6

Taken alongside

1
Deferasirox4.5%99
2
Ergocalciferol3.9%87
3
Aspirin3.8%84
4
Folic-acid3.4%76
5
Furosemide2.5%56
6
Levothyroxine-sodium2.5%56
7
Metoprolol2.4%53
8
Omeprazole2.4%52
9
Acetaminophen2.4%52
10
Cyanocobalamin2.0%45
11
Atorvastatin-calcium2.0%45
12
Pantoprazole-sodium1.9%41
13
Metformin1.7%38
14
Allopurinol1.6%35
15
Ondansetron1.3%28

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 luspatercept side effects

30.2% of luspatercept adverse event reports involve female patients and 41.1% involve male patients. The largest age group is elderly at 79%. These figures reflect who reports side effects, not underlying risk.

Sex

Female30.2%
Male41.1%
Unknown28.7%

Age group

< 20.3%
2–110.0%
12–17<0.1%
18–6420.5%
65+79.2%

What is luspatercept used for

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

5q Minus SyndromeAcute Myeloid LeukaemiaAnaemiaAnaemia Of Chronic DiseaseAnaemia Of Malignant DiseaseAcute Erythroid LeukaemiaAcute Myeloid LeukaemiaAnaemiaAnaemia MacrocyticAnaemia Of Malignant DiseaseAplastic AnaemiaBlood Product Transfusion DependentBlood DisorderCardiac Failure ChronicChelation Therapy

Showing 15 of 68 indications

Luspatercept brand names and reporting trend

Luspatercept is sold under the brand name Reblozyl.

Brand names

Reblozyl485

Quarterly reports (20182025)

20182020202220242025

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

Taking luspatercept with another medication?

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