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Protamine Side Effects

The most commonly reported side effects of protamine include pain, renal failure, and injury, based on 1,973 FDA adverse event reports from 2004 to 2025.

Protamine side effects

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

1
Pain52.1%1,028
2
Renal Failure50.6%998
3
Injury49.1%969
4
Unevaluable Event47.1%930
5
Anxiety45.6%899
6
Fear42.3%835
7
Renal Injury36.8%726
8
Emotional Distress35.8%706
9
Anhedonia31.6%623
10
Renal Impairment29.9%590
11
Stress29.5%583
12
Death22.5%443
13
Multi-organ Failure22.2%438
14
Depression17.2%340
15
Cerebrovascular Accident10.7%212

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

Report severity

93.6%Serious1,846 reports
37.4%Hospitalizations738 reports
35.4%Fatal698 reports

Seriousness is determined by the reporter, not by OpenClaim.

Protamine drug interactions

Other drugs that appear in adverse event reports alongside protamine. 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
Aprotinin55.9%1,102
2
Heparin7.0%139
3
Propofol2.5%49
4
Busulfan1.8%35
5
Methotrexate1.8%35
6
Aspirin1.7%34
7
Cyclophosphamide1.7%34
8
Tranexamic-acid1.6%31
9
Fludarabine-phosphate1.6%31
10
Enoxaparin-sodium1.5%29
11
Midazolam1.5%29
12
Sufentanil-citrate1.5%29
13
Warfarin1.3%25
14
Etoposide1.2%23
15
Pantoprazole-sodium1.0%20

Taken alongside

1
Heparin65.4%1,290
2
Furosemide37.8%745
3
Midazolam37.3%736
4
Fentanyl29.9%589
5
Nitroglycerin26.5%522
6
Metoprolol25.5%504
7
Cefazolin-sodium24.7%487
8
Insulin21.6%426
9
Vancomycin20.9%412
10
Mannitol20.4%403
11
Epinephrine19.1%376
12
Lidocaine17.4%343
13
Potassium-chloride17.0%335
14
Dopamine-hydrochloride16.6%328
15
Aspirin15.0%296

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 protamine side effects

36.0% of protamine adverse event reports involve female patients and 54.0% involve male patients. The largest age group is elderly at 47%. These figures reflect who reports side effects, not underlying risk.

Sex

Female36.0%
Male54.0%
Unknown9.9%

Age group

< 22.4%
2–112.5%
12–171.6%
18–6446.0%
65+47.4%

What is protamine used for

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

Abdominal Hernia RepairActivated Partial Thromboplastin Time ProlongedAfibAllergy TestAnaesthesiaAngiogramAngioplastyAnticoagulant TherapyAortic DissectionAortic SurgeryArterial Bypass OperationArterial Occlusive DiseaseArteriovenous Fistula OperationAnticoagulant TherapyAnticoagulation Drug Level

Showing 15 of 96 indications

Protamine brand names and reporting trend

Protamine is sold under the brand name Protamine Sulfate.

Brand names

Protamine Sulfate2,210

Quarterly reports (20042025)

20052010201520202025

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

Taking protamine with another medication?

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