TRIAL RESULTS · SIDE EFFECTS
Difelikefalin side effects
ANSWER
In 1 placebo-controlled trial with posted results, the most common side effects of Difelikefalin were hyperkalaemia 17.7% (placebo 17.3%), dialysis hypotension 13.8% (placebo 10.3%), hypotension 13.8% (placebo 9.5%). Read from ClinicalTrials.gov on 2026-10-03. Not medical advice.
Trial register
Trials with posted results
1
with an arm on Difelikefalin, of 25 registered
Against placebo
1
placebo-controlled trials
People in those trials
232
on Difelikefalin · 243 on placebo
Read
2026-10-03
ClinicalTrials.gov
VS PLACEBO
Most common side effects, Difelikefalin beside placebo
Share of people with each side effect in 1 placebo-controlled trial with posted results: 232 people on Difelikefalin (all doses), 243 on placebo, same trials. Listed only when reported for at least half of the people on Difelikefalin. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
ALL TRIALS
All 61 side effects reported
Every trial with posted results and an arm on Difelikefalin (n ≥ 20), all phases, by people affected. Placebo is shown where placebo-controlled trials reported the same event. Comparator arms are not counted.
| Side effect | Organ system | Difelikefalin | Placebo | Trials |
|---|---|---|---|---|
| Hyperkalaemia | Metabolism and nutrition disorders | 17.7% (41 of 232) | 17.3% | 1 |
| Dialysis hypotension | Vascular disorders | 13.8% (32 of 232) | 10.3% | 1 |
| Hypotension | Vascular disorders | 13.8% (32 of 232) | 9.5% | 1 |
| Muscle spasms | Musculoskeletal and connective tissue disorders | 12.5% (29 of 232) | 10.7% | 1 |
| Upper respiratory tract infection | Infections and infestations | 9.5% (22 of 232) | 10.3% | 1 |
| Dizziness | Nervous system disorders | 9.5% (22 of 232) | 5.8% | 1 |
| Diarrhoea | Gastrointestinal disorders | 5.6% (13 of 232) | 3.7% | 1 |
| Constipation | Gastrointestinal disorders | 5.6% (13 of 232) | 2.1% | 1 |
| Palpitations | Cardiac disorders | 5.2% (12 of 232) | 4.9% | 1 |
| Hypocalcaemia | Metabolism and nutrition disorders | 4.3% (10 of 232) | 1.6% | 1 |
| Cough | Respiratory, thoracic and mediastinal disorders | 4.3% (10 of 232) | 3.7% | 1 |
| Tachycardia | Cardiac disorders | 3.9% (9 of 232) | 6.2% | 1 |
| Insomnia | Psychiatric disorders | 3.4% (8 of 232) | 2.5% | 1 |
| Hypercalcaemia | Metabolism and nutrition disorders | 3.0% (7 of 232) | 2.9% | 1 |
| Arteriovenous fistula thrombosis | Injury, poisoning and procedural complications | 1.3% (3 of 232) | 0.4% | 1 |
| Cerebral infarction | Nervous system disorders | 1.3% (3 of 232) | 0.0% | 1 |
| Acute myocardial infarction | Cardiac disorders | 0.9% (2 of 232) | 0.0% | 1 |
| Cardiac failure chronic | Cardiac disorders | 0.9% (2 of 232) | 0.0% | 1 |
| Pneumonia bacterial | Infections and infestations | 0.9% (2 of 232) | 0.0% | 1 |
| Arteriovenous fistula site complication | Injury, poisoning and procedural complications | 0.9% (2 of 232) | 0.8% | 1 |
| Arteriovenous fistula occlusion | Injury, poisoning and procedural complications | 0.9% (2 of 232) | 0.4% | 1 |
| Spinal compression fracture | Injury, poisoning and procedural complications | 0.9% (2 of 232) | 0.0% | 1 |
| Mental status changes | Psychiatric disorders | 0.9% (2 of 232) | 0.4% | 1 |
| Acute coronary syndrome | Cardiac disorders | 0.4% (1 of 232) | 0.4% | 1 |
| Cardiac failure acute | Cardiac disorders | 0.4% (1 of 232) | 0.8% | 1 |
| Angina pectoris | Cardiac disorders | 0.4% (1 of 232) | 0.0% | 1 |
| Pneumonia | Infections and infestations | 0.4% (1 of 232) | 1.6% | 1 |
| Respiratory tract infection | Infections and infestations | 0.4% (1 of 232) | 0.4% | 1 |
| Febrile infection | Infections and infestations | 0.4% (1 of 232) | 0.0% | 1 |
| Postoperative wound infection | Infections and infestations | 0.4% (1 of 232) | 0.0% | 1 |
| Urinary tract infection | Infections and infestations | 0.4% (1 of 232) | 0.0% | 1 |
| Fall | Injury, poisoning and procedural complications | 0.4% (1 of 232) | 0.0% | 1 |
| Humerus fracture | Injury, poisoning and procedural complications | 0.4% (1 of 232) | 0.0% | 1 |
| Vitreous haemorrhage | Eye disorders | 0.4% (1 of 232) | 0.0% | 1 |
| Cataract cortical | Eye disorders | 0.4% (1 of 232) | 0.0% | 1 |
| Pyrexia | General disorders | 0.4% (1 of 232) | 0.0% | 1 |
| Chest pain | General disorders | 0.4% (1 of 232) | 0.0% | 1 |
| Loss of consciousness | Nervous system disorders | 0.4% (1 of 232) | 0.0% | 1 |
| Post herpetic neuralgia | Nervous system disorders | 0.4% (1 of 232) | 0.0% | 1 |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | 0.4% (1 of 232) | 0.4% | 1 |
| Nausea | Gastrointestinal disorders | 0.4% (1 of 232) | 0.0% | 1 |
| Vomiting | Gastrointestinal disorders | 0.4% (1 of 232) | 0.0% | 1 |
| Venous stenosis | Vascular disorders | 0.4% (1 of 232) | 0.0% | 1 |
| Tinnitus | Ear and labyrinth disorders | 0.4% (1 of 232) | 0.0% | 1 |
| Invasive breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0.4% (1 of 232) | 0.0% | 1 |
| Vascular access placement | Surgical and medical procedures | 0.4% (1 of 232) | 0.0% | 1 |
| Cardiac failure | Cardiac disorders | 0.0% (0 of 232) | 0.8% | 1 |
| Myocardial injury | Cardiac disorders | 0.0% (0 of 232) | 0.4% | 1 |
| Coronary artery disease | Cardiac disorders | 0.0% (0 of 232) | 0.4% | 1 |
| Abdominal infection | Infections and infestations | 0.0% (0 of 232) | 0.4% | 1 |
| Sepsis | Infections and infestations | 0.0% (0 of 232) | 0.4% | 1 |
| Corneal opacity | Eye disorders | 0.0% (0 of 232) | 0.4% | 1 |
| Retinal artery occlusion | Eye disorders | 0.0% (0 of 232) | 0.8% | 1 |
| Gait disturbance | General disorders | 0.0% (0 of 232) | 0.4% | 1 |
| Fatigue | General disorders | 0.0% (0 of 232) | 0.4% | 1 |
| Cerebral haemorrhage | Nervous system disorders | 0.0% (0 of 232) | 0.4% | 1 |
| Asthma | Respiratory, thoracic and mediastinal disorders | 0.0% (0 of 232) | 0.4% | 1 |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | 0.0% (0 of 232) | 0.4% | 1 |
| Anaemia | Blood and lymphatic system disorders | 0.0% (0 of 232) | 0.4% | 1 |
| Cholecystitis acute | Hepatobiliary disorders | 0.0% (0 of 232) | 0.4% | 1 |
| Renal cyst haemorrhage | Renal and urinary disorders | 0.0% (0 of 232) | 0.4% | 1 |
Source: ClinicalTrials.gov posted results, read 2026-10-03. A trial lists events above its own reporting threshold, so a rare event may be missing from some trials. Not medical advice.
FDA LABEL
What the FDA label says
Korsuva NDA214916 · label of 2025-08-26 Regulator
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.
QUESTIONS
Does difelikefalin cause hyperkalaemia?
In 1 placebo-controlled trial with posted results, 17.7% of people on difelikefalin reported hyperkalaemia, against 17.3% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does difelikefalin cause dialysis hypotension?
In 1 placebo-controlled trial with posted results, 13.8% of people on difelikefalin reported dialysis hypotension, against 10.3% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does difelikefalin cause hypotension?
In 1 placebo-controlled trial with posted results, 13.8% of people on difelikefalin reported hypotension, against 9.5% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does difelikefalin cause muscle spasms?
In 1 placebo-controlled trial with posted results, 12.5% of people on difelikefalin reported muscle spasms, against 10.7% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does difelikefalin cause upper respiratory tract infection?
In 1 placebo-controlled trial with posted results, 9.5% of people on difelikefalin reported upper respiratory tract infection, against 10.3% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
REGISTERED STUDIES
25 registered clinical trials of Difelikefalin
The 10 most recently updated are listed.
| NCT06593392 | Safety and Tolerability of Difelikefalin in Adolescents on Haemodialysis With Moderate-to-Severe Pruritus Status: RECRUITING · Updated 2026-09-01 |
|---|---|
| 2023-509909-74-00 | An Open-label, Single Arm Study to Evaluate the Safety and Tolerability of Intravenous Difelikefalin in Adolescents Aged 12 to 17 Years on Haemodialysis with Moderate-to-Severe Pruritus (KOR-PED-202) Status: UNKNOWN · Updated 2026-08-24 |
| NCT07526324 | Difelikefalin for Itching in Hemodialysis Patients With Chronic Kidney Disease Status: NOT_YET_RECRUITING · Updated 2026-04-13 |
| NCT05885737 | Phase 3 Study of Difelikefalin in Haemodialysis Chinese Adult Subjects With Moderate-to-Severe Pruritus Status: COMPLETED · Updated 2025-09-12 |
| NCT05885763 | Pharmacokinetics of Intravenous Difelikefalin in Chinese Adult Subjects on Haemodialysis Status: COMPLETED · Updated 2025-02-14 |
| NCT05978063 | Study to Evaluate the Efficacy and Safety of Oral Difelikefalin for Moderate to Severe Pruritus in Subjects With Notalgia Paresthetica Status: TERMINATED · Updated 2024-06-21 |
| NCT05342623 | A Study to Evaluate the Safety and Efficacy of Difelikefalin in Advanced Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus Status: TERMINATED · Updated 2024-05-07 |
| NCT05356403 | CR845-310302: A Study to Evaluate the Safety and Efficacy of Difelikefalin in Advanced Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus Status: TERMINATED · Updated 2024-05-07 |
| 2023-503957-36-00 | A 2-part, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Oral Difelikefalin for Moderate-to-Severe Pruritus in Adult Subjects with Notalgia Paresthetica Status: UNKNOWN · Updated 2024-04-29 |
| NCT05387707 | Study to Evaluate the Efficacy and Safety of Oral Difelikefalin as Adjunct Therapy to a Topical Corticosteroid for Moderate to Severe Pruritus in Subjects With Atopic Dermatitis Status: TERMINATED · Updated 2024-02-22 |
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