Difelikefalin: uses, dosing, side effects & brands
Difelikefalin is a medicine sold in the U.S. under one brand, for pruritus. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Treats
- Pruritus
- Available as
- Injectable
- Sold as
- Korsuva
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How difelikefalin is dosed
From the FDA label for Korsuva (application NDA214916). Other difelikefalin products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Recommended dosage is 0.5 mcg/kg. ( 2.1 ) Administer by intravenous bolus injection into the venous line of the dialysis circuit at the end of each HD treatment. ( 2.1 ) Do not mix or dilute KORSUVA prior to administration. ( 2.2 ) Administer within 4 hours of syringe preparation. ( 2.3 ) See full prescribing information for additional recommendations on preparation and administration of KORSUVA. ( 2.2 , 2.3 ) 2.1 Dosage The recommended dosage of KORSUVA is 0.5 mcg/kg administered by intravenous bolus injection into the venous line of the dialysis circuit at the end of each HD treatment [see Dosage and Administration (2.3) ] . If a regularly scheduled HD treatment is missed, resume KORSUVA at the end of the next HD treatment. 2.2 Preparation Instructions Do not mix or dilute KORSUVA prior to administration. Inspect KORSUVA for particulate matter and discoloration prior to administration. The solution should be clear and colorless. Do not use KORSUVA vials if particulate matter or discoloration is observed. KORSUVA is supplied in a single-dose vial. Discard any unused product. Injection volume to be administered is determined by patient's target dry body weight in kilograms (one patient may use less than the full contents of the vial or use more than one vial). See Table 1 . Table 1. KORSUVA Injection Volumes Based on Target Dry Body Weight Target Dry Body Weight Range (kg)…
Difelikefalin side effects
The following clinically significant adverse reactions are described elsewhere in the labeling: Dizziness, Somnolence, Mental Status Changes, and Gait Disturbances [see Warnings and Precautions (5.1) ] The most common adverse reactions (incidence ≥2% and ≥1% higher than placebo) were diarrhea, dizziness, nausea, gait disturbances, including falls, hyperkalemia, headache, somnolence, and mental status change. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Vifor (International) Inc. at 1-844-835-8277 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. A total of 1306 subjects undergoing HD who had moderate-to-severe pruritus were treated with KORSUVA in placebo-controlled and uncontrolled Phase 3 clinical trials. Of these, 711 were treated for at least 6 months and 400 were treated for at least one year. Two placebo-controlled Phase 3 trials (Trial 1 and Trial 2), in subjects undergoing HD who had moderate-to-severe pruritus were pooled to evaluate the safety of KORSUVA in comparison to placebo up to 12 weeks. In total, 848 subjects were evaluated (424 in KORSUVA group and 424 in…
Who shouldn’t take difelikefalin
None None
Every difelikefalin product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Korsuva.
What people report to the FDA about difelikefalin
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 17 reports naming difelikefalin, and the FDA flagged 71% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- somnolence5 reports
- fatigue3 reports
- aggression2 reports
- anxiety1 reports
- bronchial carcinoma1 reports
- cerebral haemorrhage1 reports
- face oedema1 reports
- hypersensitivity1 reports
Read these as a signal, not a rate. A report does not mean difelikefalin caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
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Frequently asked questions
What is difelikefalin?
Korsuva (Difelikefalin Acetate) is a medication used to treat Pruritus.
Can you take difelikefalin with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run difelikefalin against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does difelikefalin come in?
Across the brands we track, difelikefalin is currently marketed as injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic difelikefalin?
We do not currently list a generic-labelled difelikefalin product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Difelikefalin: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/difelikefalin
- MLA
- “Difelikefalin: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/difelikefalin.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for difelikefalin on DailyMed (NIH) ↗.