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Eculizumab Side Effects

The most commonly reported side effects of eculizumab include fatigue, off label use, and haemoglobin decreased, based on 54,637 FDA adverse event reports from 2007 to 2025. 3.4% of reports found the drug to be ineffective.

Eculizumab side effects

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

1
Fatigue10.0%5,443
2
Off Label Use8.5%4,653
3
Haemoglobin Decreased6.4%3,506
4
Headache5.5%3,031
5
Death4.7%2,572
6
Pyrexia4.1%2,217
7
Dyspnoea3.7%2,044
8
Asthenia3.4%1,883
9
Drug Ineffective3.4%1,855
10
Nausea3.3%1,797
11
Platelet Count Decreased3.1%1,718
12
Haemolysis3.1%1,710
13
Malaise3.1%1,709
14
Blood Lactate Dehydrogenase Increased2.6%1,443
15
Abdominal Pain2.6%1,411

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

Report severity

59.0%Serious32,262 reports
28.2%Hospitalizations15,406 reports
10.3%Fatal5,613 reports

Seriousness is determined by the reporter, not by OpenClaim.

Eculizumab drug interactions

Other drugs that appear in adverse event reports alongside eculizumab. 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
Ravulizumab-cwvz2.1%1,129
2
Mycophenolate1.3%698
3
Prednisone1.2%646
4
Rituximab1.0%539
5
Tacrolimus0.8%459
6
Methylprednisolone0.5%290
7
Cyclosporine0.5%266
8
Cyclophosphamide0.4%213
9
Azathioprine0.4%193
10
Prednisolone0.4%192
11
Penicillin0.2%120
12
Amlodipine0.2%118
13
Warfarin0.2%99
14
Pyridostigmine-bromide0.2%97
15
Deferasirox0.2%89

Taken alongside

1
Folic-acid4.9%2,683
2
Prednisone4.4%2,396
3
Acetaminophen2.7%1,486
4
Amlodipine2.1%1,132
5
Warfarin1.9%1,059
6
Furosemide1.8%1,003
7
Mycophenolate1.7%953
8
Penicillin1.7%924
9
Ergocalciferol1.5%843
10
Aspirin1.5%805
11
Cyclosporine1.5%799
12
Tacrolimus1.5%799
13
Omeprazole1.4%740
14
Pantoprazole-sodium1.1%602
15
Levothyroxine-sodium1.1%575

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 eculizumab side effects

47.2% of eculizumab adverse event reports involve female patients and 31.9% involve male patients. The largest age group is adult at 62%. These figures reflect who reports side effects, not underlying risk.

Sex

Female47.2%
Male31.9%
Unknown20.8%

Age group

< 23.8%
2–117.5%
12–174.5%
18–6462.0%
65+22.2%

What is eculizumab used for

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

Abdominal PainAccidental ExposureAccidental Exposure To ProductActivated Partial Thromboplastin Time AbnormalAcute Kidney InjuryAcute Lymphocytic LeukaemiaAcute Myeloid LeukaemiaAcute Respiratory Distress SyndromeAdenocarcinoma PancreasAllogenic Bone Marrow Transplantation TherapyAllogenic Stem Cell TransplantationAlloimmunisationAnaemiaAnaemia Haemolytic AutoimmuneAnaphylactic Reaction

Showing 15 of 505 indications

Eculizumab brand names and reporting trend

Eculizumab is sold under the brand name Soliris.

Brand names

Soliris3,473

Quarterly reports (20072025)

20072010201520202025

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

Taking eculizumab with another medication?

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