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Caplacizumab Side Effects

The most commonly reported side effects of caplacizumab include product use in unapproved indication, off label use, and adamts13 activity decreased, based on 1,692 FDA adverse event reports from 2019 to 2025.

Caplacizumab side effects

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

1
Product Use In Unapproved Indication30.3%513
2
Off Label Use12.3%208
3
Adamts13 Activity Decreased9.4%159
4
Platelet Count Decreased8.3%140
5
Epistaxis8.0%136
6
Fatigue6.7%113
7
Contusion5.3%90
8
Headache4.9%83
9
Thrombotic Thrombocytopenic Purpura4.7%80
10
Injection Site Pain4.7%79
11
Condition Aggravated4.6%78
12
Adamts13 Activity Abnormal4.0%68
13
Injection Site Bruising3.8%65
14
Haemoglobin Decreased3.0%51
15
Hospitalisation3.0%51

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

Report severity

44.0%Serious744 reports
21.0%Hospitalizations356 reports
5.9%Fatal100 reports

Seriousness is determined by the reporter, not by OpenClaim.

Caplacizumab drug interactions

Other drugs that appear in adverse event reports alongside caplacizumab. 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
Rituximab11.3%191
2
Prednisone4.8%81
3
Methylprednisolone2.2%37
4
Cyclosporine1.4%24
5
Lansoprazole1.3%22
6
Bortezomib1.2%20
7
Sulfamethoxazole0.9%15
8
Enoxaparin-sodium0.9%15
9
Prednisolone0.8%14
10
Trimethoprim0.8%13
11
Azathioprine0.5%9
12
Mycophenolate0.5%8
13
Potassium-chloride0.5%8
14
Eculizumab0.4%7
15
Quetiapine-fumarate0.4%6

Taken alongside

1
Rituximab8.0%136
2
Prednisone4.4%75
3
Methylprednisolone3.7%62
4
Prednisolone2.0%33
5
Folic-acid1.7%28
6
Pantoprazole-sodium1.4%24
7
Aspirin1.4%23
8
Heparin1.1%19
9
Enoxaparin-sodium1.1%18
10
Amlodipine1.0%17
11
Acetaminophen1.0%17
12
Levothyroxine-sodium0.9%15
13
Omeprazole0.9%15
14
Azathioprine0.8%13
15
Furosemide0.7%12

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 caplacizumab side effects

58.0% of caplacizumab adverse event reports involve female patients and 25.6% involve male patients. The largest age group is adult at 81%. These figures reflect who reports side effects, not underlying risk.

Sex

Female58.0%
Male25.6%
Unknown16.4%

Age group

< 20.4%
2–110.8%
12–173.3%
18–6480.6%
65+14.9%

What is caplacizumab used for

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

Activated Partial Thromboplastin TimeAdamts13 Activity DecreasedActivated Partial Thromboplastin TimeAdverse Drug ReactionAnaemiaAtypical Haemolytic Uraemic SyndromeBlood DisorderCongenital Thrombotic Thrombocytopenic PurpuraCoombs Test PositiveEvans SyndromeFoetal Exposure During PregnancyGlomerular Vascular DisorderHaemolytic AnaemiaHaemolytic Uraemic SyndromeHaemorrhage

Showing 15 of 41 indications

Caplacizumab brand names and reporting trend

Caplacizumab is sold under the brand name Cablivi.

Brand names

Cablivi962

Quarterly reports (20192025)

20192020202220242025

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

Taking caplacizumab with another medication?

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