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Ravulizumab Side Effects

The most commonly reported side effects of ravulizumab include fatigue, asthenia, and headache, based on 11,369 FDA adverse event reports from 2019 to 2025. 5.6% of reports found the drug to be ineffective.

Ravulizumab side effects

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

1
Fatigue13.8%1,571
2
Asthenia6.8%778
3
Headache6.0%686
4
Drug Ineffective5.6%634
5
Off Label Use4.5%509
6
Dyspnoea3.9%446
7
Muscular Weakness3.9%445
8
Myasthenia Gravis3.5%396
9
Malaise3.4%385
10
Death3.3%378
11
Haemoglobin Decreased3.2%367
12
Pain3.1%347
13
Back Pain2.9%333
14
Feeling Abnormal2.9%328
15
Therapeutic Response Shortened2.8%321

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

Report severity

49.3%Serious5,605 reports
18.0%Hospitalizations2,048 reports
5.8%Fatal658 reports

Seriousness is determined by the reporter, not by OpenClaim.

Ravulizumab drug interactions

Other drugs that appear in adverse event reports alongside ravulizumab. 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
Eculizumab9.9%1,129
2
Danicopan1.2%136
3
Prednisone1.0%112
4
Pyridostigmine-bromide0.7%76
5
Pegcetacoplan0.6%73
6
Tacrolimus0.3%34
7
Diphenhydramine0.3%33
8
Mycophenolate0.3%32
9
Penicillin0.3%29
10
Efgartigimod0.2%24
11
Prednisolone0.2%23
12
Azathioprine0.2%20
13
Rituximab0.2%19
14
Zilucoplan-sodium0.2%19
15
Inebilizumab-cdon0.1%17

Taken alongside

1
Prednisone4.4%501
2
Pyridostigmine-bromide3.7%415
3
Acetaminophen1.8%203
4
Ergocalciferol1.8%202
5
Folic-acid1.5%166
6
Diphenhydramine1.3%151
7
Mycophenolate1.3%150
8
Sodium-chloride1.3%145
9
Penicillin1.1%127
10
Epinephrine1.1%125
11
Amlodipine1.0%118
12
Aspirin1.0%118
13
Atorvastatin-calcium1.0%112
14
Levothyroxine-sodium1.0%111
15
Prednisolone1.0%110

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 ravulizumab side effects

45.7% of ravulizumab adverse event reports involve female patients and 39.1% involve male patients. The largest age group is adult at 49%. These figures reflect who reports side effects, not underlying risk.

Sex

Female45.7%
Male39.1%
Unknown15.2%

Age group

< 20.8%
2–112.6%
12–171.6%
18–6448.6%
65+46.4%

What is ravulizumab used for

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

Amyotrophic Lateral SclerosisAnaemiaAplastic AnaemiaAtypical Haemolytic Uraemic SyndromeAmyotrophic Lateral SclerosisAnaemiaAnal CancerAnti-aquaporin-4 Antibody PositiveAnti-neutrophil Cytoplasmic Antibody Positive VasculitisAntiphospholipid SyndromeAplastic AnaemiaArterial DisorderAstheniaAtypical Haemolytic Uraemic SyndromeAutoimmune Disorder

Showing 15 of 118 indications

Ravulizumab brand names and reporting trend

Ravulizumab is sold under the brand name Ultomiris.

Brand names

Ultomiris745

Quarterly reports (20192025)

20192020202220242025

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

Taking ravulizumab with another medication?

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