OpenClaim

Idarucizumab Side Effects

The most commonly reported side effects of idarucizumab include death, haemorrhage, and gastrointestinal haemorrhage, based on 1,424 FDA adverse event reports from 2015 to 2025. 4.5% of reports found the drug to be ineffective.

Idarucizumab side effects

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

1
Death11.9%169
2
Haemorrhage8.3%118
3
Gastrointestinal Haemorrhage5.7%81
4
Cerebral Haemorrhage5.5%78
5
Haemorrhage Intracranial4.7%67
6
Drug Ineffective4.5%64
7
Multiple Organ Dysfunction Syndrome4.4%62
8
Acute Kidney Injury3.4%48
9
Sepsis3.2%46
10
Ischaemic Stroke3.0%43
11
Pneumonia2.9%41
12
Shock Haemorrhagic2.7%39
13
Septic Shock2.3%33
14
Cerebrovascular Accident2.2%32
15
Coagulopathy2.2%31

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

Report severity

97.3%Serious1,386 reports
36.0%Hospitalizations513 reports
62.5%Fatal890 reports

Seriousness is determined by the reporter, not by OpenClaim.

Idarucizumab drug interactions

Other drugs that appear in adverse event reports alongside idarucizumab. 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
Dabigatran-etexilate-mesylate7.1%101
2
Alteplase1.1%16
3
Gemfibrozil0.9%13
4
Aspirin0.9%13
5
Heparin0.7%10
6
Epinephrine0.6%9
7
Insulin0.6%9
8
Rivaroxaban0.5%7
9
Bisoprolol-fumarate0.5%7
10
Tranexamic-acid0.5%7
11
Vitamin-k0.4%6
12
Omeprazole0.4%5
13
Metformin0.4%5
14
Formoterol0.4%5
15
Ipratropium-bromide0.4%5

Taken alongside

1
Furosemide7.2%103
2
Dabigatran-etexilate-mesylate5.3%75
3
Bisoprolol-fumarate5.2%74
4
Atorvastatin-calcium4.1%59
5
Metoprolol3.2%46
6
Amiodarone-hydrochloride3.1%44
7
Omeprazole2.9%41
8
Digoxin2.7%39
9
Pantoprazole-sodium2.7%39
10
Levothyroxine-sodium2.7%39
11
Amlodipine2.5%35
12
Spironolactone2.3%33
13
Metformin2.2%32
14
Ramipril2.2%31
15
Insulin2.1%30

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 idarucizumab side effects

38.2% of idarucizumab adverse event reports involve female patients and 48.3% involve male patients. The largest age group is elderly at 89%. These figures reflect who reports side effects, not underlying risk.

Sex

Female38.2%
Male48.3%
Unknown13.5%

Age group

< 20.0%
2–110.0%
12–170.0%
18–6410.9%
65+89.1%

What is idarucizumab used for

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

Abdominal OperationActivated Partial Thromboplastin Time ProlongedAcute AbdomenAnaemiaAneurysm RupturedAnticoagulant TherapyAnticoagulation Drug LevelAnticoagulation Drug Level DecreasedAortic AneurysmAortic DissectionArterial HaemorrhageAspiration Pleural CavityAtrial FibrillationAnticoagulant TherapyAortic Aneurysm Rupture

Showing 15 of 171 indications

Idarucizumab brand names and reporting trend

Idarucizumab is sold under the brand name Praxbind.

Brand names

Praxbind167

Quarterly reports (20152025)

2016202020242025

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

Taking idarucizumab with another medication?

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