TRIAL RESULTS · SIDE EFFECTS
Etelcalcetide side effects
ANSWER
In 4 placebo-controlled trials with posted results, the most common side effects of Etelcalcetide were blood calcium decreased 46.6% (placebo 30.3%), diarrhoea 10.6% (placebo 9.3%), muscle spasms 10.0% (placebo 7.8%). Read from ClinicalTrials.gov on 2026-10-03. Not medical advice.
Trial register
Trials with posted results
12
with an arm on Etelcalcetide, of 24 registered
Against placebo
4
placebo-controlled trials
People in those trials
1,031
on Etelcalcetide · 917 on placebo
Read
2026-10-03
ClinicalTrials.gov
VS PLACEBO
Most common side effects, Etelcalcetide beside placebo
Share of people with each side effect in 4 placebo-controlled trials with posted results: 1,031 people on Etelcalcetide (all doses), 917 on placebo, same trials. Listed only when reported for at least half of the people on Etelcalcetide. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
ALL TRIALS
The 100 most reported of 829 side effects reported
Every trial with posted results and an arm on Etelcalcetide (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 | Etelcalcetide | Placebo | Trials |
|---|---|---|---|---|
| Blood calcium decreased | Investigations | 46.7% (1,244 of 2,663) | 30.3% | 10 |
| Nausea | Gastrointestinal disorders | 9.7% (256 of 2,638) | 8.1% | 9 |
| Muscle spasms | Musculoskeletal and connective tissue disorders | 9.6% (248 of 2,575) | 7.8% | 7 |
| Diarrhoea | Gastrointestinal disorders | 9.3% (243 of 2,617) | 9.3% | 8 |
| Vomiting | Gastrointestinal disorders | 8.6% (221 of 2,571) | 7.3% | 7 |
| Hypotension | Vascular disorders | 6.8% (178 of 2,626) | 6.7% | 9 |
| Hypertension | Vascular disorders | 6.1% (160 of 2,626) | 6.3% | 9 |
| Upper respiratory tract infection | Infections and infestations | 6.7% (154 of 2,304) | 3.9% | 8 |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 6.2% (127 of 2,056) | 4.3% | 7 |
| Cough | Respiratory, thoracic and mediastinal disorders | 5.9% (118 of 1,991) | 5.6% | 5 |
| Hyperphosphataemia | Metabolism and nutrition disorders | 8.9% (109 of 1,227) | - | 3 |
| Hypocalcaemia | Metabolism and nutrition disorders | 5.5% (96 of 1,758) | 0.3% | 8 |
| Back pain | Musculoskeletal and connective tissue disorders | 4.7% (89 of 1,894) | 4.0% | 4 |
| Headache | Nervous system disorders | 3.9% (88 of 2,253) | 6.1% | 6 |
| Arteriovenous fistula site complication | Injury, poisoning and procedural complications | 3.1% (80 of 2,580) | 5.4% | 7 |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 3.1% (78 of 2,550) | 3.1% | 6 |
| Pneumonia | Infections and infestations | 2.7% (74 of 2,790) | 2.3% | 10 |
| Nasopharyngitis | Infections and infestations | 6.0% (66 of 1,106) | 5.0% | 4 |
| Hyperkalaemia | Metabolism and nutrition disorders | 2.3% (64 of 2,728) | 1.8% | 8 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 2.5% (53 of 2,109) | 5.3% | 5 |
| Anaemia | Blood and lymphatic system disorders | 1.9% (49 of 2,601) | 2.2% | 8 |
| Fluid overload | Metabolism and nutrition disorders | 1.7% (41 of 2,431) | 1.2% | 8 |
| Sepsis | Infections and infestations | 1.8% (40 of 2,262) | 1.6% | 6 |
| Arteriovenous fistula thrombosis | Injury, poisoning and procedural complications | 1.5% (38 of 2,580) | 1.0% | 7 |
| Dizziness | Nervous system disorders | 1.7% (35 of 2,077) | 0.0% | 5 |
| Cardiac arrest | Cardiac disorders | 1.2% (30 of 2,446) | 1.1% | 6 |
| Fall | Injury, poisoning and procedural complications | 1.7% (28 of 1,664) | 3.3% | 4 |
| Hypoaesthesia | Nervous system disorders | 1.3% (27 of 2,047) | 0.0% | 4 |
| Acute myocardial infarction | Cardiac disorders | 1.0% (25 of 2,484) | 1.2% | 7 |
| Abdominal pain | Gastrointestinal disorders | 1.1% (25 of 2,262) | 2.9% | 6 |
| Procedural hypotension | Injury, poisoning and procedural complications | 1.2% (25 of 2,159) | 2.6% | 6 |
| Angina pectoris | Cardiac disorders | 0.9% (24 of 2,601) | 0.5% | 8 |
| Pyrexia | General disorders | 0.9% (24 of 2,580) | 0.6% | 7 |
| Atrial fibrillation | Cardiac disorders | 1.1% (24 of 2,232) | 1.6% | 5 |
| Non-cardiac chest pain | General disorders | 1.0% (23 of 2,283) | 1.1% | 7 |
| Constipation | Gastrointestinal disorders | 1.0% (23 of 2,237) | 0.1% | 6 |
| Cardiac failure congestive | Cardiac disorders | 1.0% (23 of 2,232) | 1.5% | 5 |
| Pruritus | Skin and subcutaneous tissue disorders | 6.2% (23 of 373) | - | 3 |
| Bronchitis | Infections and infestations | 0.9% (22 of 2,571) | 2.3% | 7 |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | 0.9% (22 of 2,410) | 0.4% | 7 |
| Osteomyelitis | Infections and infestations | 0.9% (21 of 2,410) | 0.9% | 7 |
| Anxiety | Psychiatric disorders | 1.2% (21 of 1,693) | 1.2% | 5 |
| Syncope | Nervous system disorders | 1.1% (21 of 1,924) | 0.8% | 5 |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | 0.9% (19 of 2,068) | 0.6% | 7 |
| Septic shock | Infections and infestations | 1.1% (19 of 1,672) | 0.6% | 4 |
| Gangrene | Infections and infestations | 0.8% (18 of 2,262) | 0.2% | 6 |
| Dialysis hypotension | Vascular disorders | 5.7% (18 of 318) | - | 1 |
| Coronary artery disease | Cardiac disorders | 0.7% (17 of 2,580) | 0.6% | 7 |
| Cellulitis | Infections and infestations | 0.8% (17 of 2,232) | 1.1% | 5 |
| Paraesthesia | Nervous system disorders | 1.3% (16 of 1,186) | 1.1% | 4 |
| Myocardial infarction | Cardiac disorders | 0.8% (16 of 1,894) | 0.6% | 4 |
| Chest pain | General disorders | 1.0% (16 of 1,539) | 0.8% | 3 |
| Abdominal discomfort | Gastrointestinal disorders | 2.8% (16 of 569) | 0.0% | 2 |
| Blood calcium increased | Investigations | 5.0% (16 of 318) | - | 1 |
| Mental status changes | Psychiatric disorders | 0.7% (15 of 2,072) | 0.9% | 6 |
| Blood pressure increased | Investigations | 1.8% (15 of 855) | 0.0% | 3 |
| Chest discomfort | General disorders | 4.7% (15 of 318) | - | 1 |
| Cerebrovascular accident | Nervous system disorders | 0.5% (13 of 2,728) | 0.4% | 8 |
| Device related infection | Infections and infestations | 0.6% (13 of 2,328) | 0.2% | 6 |
| Hypoglycaemia | Metabolism and nutrition disorders | 0.7% (13 of 1,931) | 0.9% | 5 |
| Gastroenteritis | Infections and infestations | 0.5% (12 of 2,253) | 1.0% | 6 |
| Asthenia | General disorders | 0.6% (12 of 2,159) | 0.6% | 6 |
| Urinary tract infection | Infections and infestations | 0.5% (12 of 2,550) | 0.6% | 6 |
| Hypercalcaemia | Metabolism and nutrition disorders | 2.0% (12 of 591) | 1.4% | 3 |
| Arteriovenous fistula site haemorrhage | Injury, poisoning and procedural complications | 0.6% (11 of 1,981) | 0.6% | 4 |
| Cardiac failure | Cardiac disorders | 0.4% (10 of 2,550) | 0.3% | 6 |
| Skin ulcer | Skin and subcutaneous tissue disorders | 0.4% (10 of 2,550) | 0.3% | 6 |
| Decreased appetite | Metabolism and nutrition disorders | 3.1% (10 of 318) | - | 1 |
| Vascular graft thrombosis | Injury, poisoning and procedural complications | 0.6% (9 of 1,399) | 1.0% | 6 |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | 0.4% (9 of 2,550) | 0.4% | 6 |
| Cholelithiasis | Hepatobiliary disorders | 0.5% (9 of 1,924) | 0.3% | 5 |
| Vascular graft complication | Injury, poisoning and procedural complications | 0.5% (9 of 1,924) | 0.1% | 5 |
| Endocarditis | Infections and infestations | 0.5% (9 of 1,739) | 0.3% | 4 |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | 0.5% (9 of 1,673) | 0.0% | 4 |
| Peripheral vascular disorder | Vascular disorders | 0.5% (9 of 1,642) | 0.5% | 3 |
| Arteriovenous graft thrombosis | Injury, poisoning and procedural complications | 1.0% (9 of 884) | - | 1 |
| Staphylococcal bacteraemia | Infections and infestations | 0.4% (8 of 2,180) | 0.3% | 7 |
| Arteriovenous graft site infection | Infections and infestations | 0.4% (8 of 1,841) | 0.3% | 6 |
| Bacteraemia | Infections and infestations | 0.4% (8 of 2,242) | 0.3% | 6 |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | 0.3% (8 of 2,298) | 0.3% | 5 |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | 0.3% (8 of 2,298) | 0.3% | 5 |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | 0.4% (8 of 2,232) | 0.6% | 5 |
| Depression | Psychiatric disorders | 0.5% (8 of 1,759) | 0.0% | 4 |
| Cholecystitis acute | Hepatobiliary disorders | 0.5% (8 of 1,504) | 0.4% | 4 |
| Sudden death | General disorders | 0.4% (8 of 1,981) | 0.3% | 4 |
| Influenza | Infections and infestations | 0.4% (8 of 1,961) | 0.5% | 4 |
| Arteriovenous fistula occlusion | Injury, poisoning and procedural complications | 0.4% (8 of 1,961) | 0.2% | 4 |
| Vascular access complication | Injury, poisoning and procedural complications | 0.4% (8 of 2,047) | 0.0% | 4 |
| Hypertensive crisis | Vascular disorders | 0.4% (8 of 1,981) | 0.2% | 4 |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | 0.7% (8 of 1,166) | 0.0% | 3 |
| Thrombosis in device | General disorders | 0.5% (8 of 1,642) | 0.3% | 3 |
| Cardio-respiratory arrest | Cardiac disorders | 0.5% (8 of 1,729) | 0.3% | 3 |
| Respiratory tract infection | Infections and infestations | 0.5% (8 of 1,643) | 0.2% | 3 |
| Peripheral ischaemia | Vascular disorders | 0.6% (8 of 1,454) | 0.4% | 3 |
| Pancreatitis | Gastrointestinal disorders | 0.4% (7 of 1,915) | 0.2% | 5 |
| Myocardial ischaemia | Cardiac disorders | 0.4% (7 of 1,980) | 0.5% | 4 |
| Pancreatitis acute | Gastrointestinal disorders | 0.3% (7 of 2,047) | 0.5% | 4 |
| Encephalopathy | Nervous system disorders | 0.3% (7 of 2,047) | 0.0% | 4 |
| Atrioventricular block complete | Cardiac disorders | 0.4% (7 of 1,643) | 0.2% | 3 |
| Angina unstable | Cardiac disorders | 0.2% (6 of 2,550) | 0.3% | 6 |
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
PARSABIV NDA208325 · label of 2026-03-08 Regulator
The most common adverse reactions (≥ 5%) were blood calcium decreased, muscle spasms, diarrhea, nausea, vomiting, headache, hypocalcemia, and paresthesia.
QUESTIONS
Does etelcalcetide cause blood calcium decreased?
In 4 placebo-controlled trials with posted results, 46.6% of people on etelcalcetide reported blood calcium decreased, against 30.3% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does etelcalcetide cause diarrhoea?
In 4 placebo-controlled trials with posted results, 10.6% of people on etelcalcetide reported diarrhoea, against 9.3% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does etelcalcetide cause muscle spasms?
In 4 placebo-controlled trials with posted results, 10.0% of people on etelcalcetide reported muscle spasms, against 7.8% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does etelcalcetide cause nausea?
In 4 placebo-controlled trials with posted results, 9.1% of people on etelcalcetide reported nausea, against 8.1% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does etelcalcetide cause vomiting?
In 4 placebo-controlled trials with posted results, 8.9% of people on etelcalcetide reported vomiting, against 7.3% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
REGISTERED STUDIES
24 registered clinical trials of Etelcalcetide
The 10 most recently updated are listed.
| NCT03969329 | A Phase 3 Study of Etelcalcetide in Children With Secondary Hyperparathyroidism Receiving Hemodialysis Status: RECRUITING · Updated 2026-08-21 |
|---|---|
| NCT06690242 | MT1013 Injection for the Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease Status: COMPLETED · Updated 2026-07-22 |
| 2023-506471-10-00 | Phase 3, Single-arm, Open-label, Multidose, Titration, Pharmacokinetic, Pharmacodynamic, and Safety Study of Etelcalcetide in Children and Adolescents ≥ 2 to < 18 Years of age with Secondary Hyperparathyroidism and Chronic Kidney Disease Receiving Maintenance Hemodialysis Status: UNKNOWN · Updated 2026-06-10 |
| NCT03633708 | A Trial of Etelcalcetide in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis Status: RECRUITING · Updated 2026-02-27 |
| NCT06352957 | Use of ETElcalcetidefor pReserving vitamiN K-dependent proteIn activiTY ITAlian Study Status: NOT_YET_RECRUITING · Updated 2024-04-08 |
| NCT03960437 | The Effect of Etelcalcetide on CKD-MBD Status: COMPLETED · Updated 2023-09-21 |
| NCT03795558 | A Study to Investigate the Influence of PTH-lowering by Etelcalcetide (Parsabiv®) on the Calcification Propensity of Serum in Dialysis Patients Status: COMPLETED · Updated 2022-03-23 |
| NCT03299244 | Head-to-Head Study of Etelcalcetide and Cinacalcet in Asian Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT) Status: COMPLETED · Updated 2021-04-30 |
| NCT03182699 | Effect of Etelcalcetide on Cardiac Hypertrophy in Hemodialysis Patients Status: COMPLETED · Updated 2020-06-09 |
| NCT03527511 | Effect of Active Vitamin D and Etelcalcetide on Human Osteoclasts in Patients With Chronic Kidney Disease Status: COMPLETED · Updated 2020-03-31 |
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