OpenClaim

Difelikefalin Side Effects

The most commonly reported side effects of difelikefalin include dizziness, somnolence, and fall, based on 390 FDA adverse event reports from 2017 to 2025. 5.9% of reports found the drug to be ineffective.

Difelikefalin side effects

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

1
Dizziness11.0%43
2
Somnolence10.3%40
3
Fall9.0%35
4
Death7.4%29
5
Drug Ineffective5.9%23
6
Mental Status Changes5.9%23
7
Nausea4.9%19
8
Confusional State4.6%18
9
Asthenia4.1%16
10
Hallucination4.1%16
11
Pruritus3.8%15
12
Fatigue3.6%14
13
Drug Reaction With Eosinophilia And Systemic Symptoms3.6%14
14
Off Label Use3.3%13
15
Dyspnoea3.1%12

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

Report severity

69.5%Serious271 reports
30.0%Hospitalizations117 reports
14.4%Fatal56 reports

Seriousness is determined by the reporter, not by OpenClaim.

Difelikefalin drug interactions

Other drugs that appear in adverse event reports alongside difelikefalin. 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
Gabapentin4.4%17
2
Methoxy-polyethylene-glycol-epoetin-beta4.1%16
3
Acetaminophen4.1%16
4
Amitriptyline-hydrochloride3.6%14
5
Doxazosin-mesylate3.6%14
6
Ferric-oxyhydroxide1.5%6
7
Iron1.3%5
8
Diphenhydramine0.8%3
9
Dupilumab0.5%2
10
Pregabalin0.5%2
11
Cyclosporine0.3%1
12
Droxidopa0.3%1
13
Metoprolol0.3%1
14
Levoleucovorin0.3%1
15
Pyrimethamine0.3%1

Taken alongside

1
Aspirin8.7%34
2
Bisoprolol-fumarate8.7%34
3
Atorvastatin-calcium7.9%31
4
Amlodipine6.7%26
5
Clopidogrel-bisulfate6.2%24
6
Insulin5.4%21
7
Vonoprazan-fumarate5.4%21
8
Levothyroxine-sodium5.1%20
9
Gabapentin5.1%20
10
Valsartan4.9%19
11
Sevelamer4.9%19
12
Darbepoetin-alfa4.9%19
13
Sodium-polystyrene-sulfonate4.6%18
14
Acetaminophen4.6%18
15
Carvedilol4.6%18

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 difelikefalin side effects

25.9% of difelikefalin adverse event reports involve female patients and 47.9% involve male patients. The largest age group is elderly at 74%. These figures reflect who reports side effects, not underlying risk.

Sex

Female25.9%
Male47.9%
Unknown26.2%

Age group

< 20.0%
2–110.0%
12–170.0%
18–6425.7%
65+74.3%

What is difelikefalin used for

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

AzotaemiaChronic Kidney DiseaseChronic Kidney Disease-associated PruritusDialysisEnd Stage Renal DiseaseHaemodialysisHaemodialysis ComplicationNeuropathic PruritusProduct Used For Unknown IndicationProduct Used For Unknown IndicationPruritusUraemic PruritusUrticaria

Difelikefalin brand names and reporting trend

Difelikefalin is sold under the brand name Korsuva.

Brand names

Korsuva95

Quarterly reports (20172025)

201720242025

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

Taking difelikefalin with another medication?

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