What the label lists and what reports show
Etelcalcetide side effects
Etelcalcetide's FDA label: “The most common adverse reactions (≥ 5%) were blood calcium decreased, muscle spasms, diarrhea, nausea, vomiting, headache, hypocalcemia, and paresthesia.” FAERS holds 2,871 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is shunt stenosis (204 reports).
- No generic listed
Check it at the source: the etelcalcetide FDA label on DailyMed (effective March 8, 2026, Amgen, Inc); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (≥ 5%) were blood calcium decreased, muscle spasms, diarrhea, nausea, vomiting, headache, hypocalcemia, and paresthesia.
Table 2: Adverse Reactions Reported in ≥ 5% of PARSABIV-Treated Patients
| Reaction | Placebo (N = 513) | PARSABIV (N = 503) |
|---|---|---|
| Blood calcium decreased Asymptomatic reductions in calcium below 7.5 mg/dL or clinically… | 10% | 64% |
| Muscle spasms | 7% | 12% |
| Diarrhea | 9% | 11% |
| Nausea | 6% | 11% |
| Vomiting | 5% | 9% |
| Headache | 6% | 8% |
| Hypocalcemia Symptomatic reductions in corrected serum calcium < 8.3 mg/dL | 0.2% | 7% |
| Paresthesia Paresthesia includes preferred terms of paresthesia and hypoesthesia | 1% | 6% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following adverse reactions are discussed in greater detail in other sections of the labeling: Hypocalcemia [see Warnings and Precautions (5.1) ] Worsening Heart Failure [see Warnings and Precautions (5.2) ] Upper Gastrointestinal Bleeding [see Warnings and Precautions (5.3) ] Adynamic Bone [see Warnings and Precautions (5.4) ] The most common adverse reactions (≥ 5%) were blood calcium decreased, muscle spasms, diarrhea, nausea, vomiting, headache, hypocalcemia, and paresthesia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Amgen Inc. at 1-800-77-AMGEN (1-800-772-6436) 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 with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The data in Table 2 are derived from two placebo-controlled clinical studies in patients with chronic kidney disease and secondary hyperparathyroidism on hemodialysis. The data reflect exposure of 503 patients to PARSABIV with a mean duration of exposure to PARSABIV of 23.6 weeks. The mean age of patients was approximately 58 years, and 60% of the patients were male. …
Source: FDA drug label, NDA208325 (Kai Pharms Inc), as published by Amgen, Inc, effective March 8, 2026 (SPL set cd270093-c6a8-4596-a4ab-e6aa0a2c8a0c), via openFDA; the full label on DailyMed
What do FAERS reports show?
2,871 reports list etelcalcetide among the medicines taken, each a report of something that happened, not proof the medicine caused it; 333 are coded as a death and 812 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 6 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Etelcalcetide: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions