What the label lists and what reports show
Cinacalcet side effects
Cinacalcet's FDA label: “The most common adverse reactions (i.e., ≥ 25%) associated with cinacalcet were nausea and vomiting.” FAERS holds 48,765 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 laboratory test abnormal (4,226 reports).
- Generic listed
Check it at the source: the cinacalcet FDA label on DailyMed (effective April 2, 2026, Aurobindo Pharma Limited); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (i.e., ≥ 25%) associated with cinacalcet were nausea and vomiting.
Table 4. Adverse Reactions Occurring in ≥ 10% of Subjects in a Double-Blind, Placebo-Controlled Study in Patients with Primary Hyperparathyroidism
| Adverse Reaction | Placebo (n = 34) n (%) | Cinacalcet (n = 33) n (%) |
|---|---|---|
| Nausea | 6 (18) | 10 (30) |
| Muscle spasms | 0 (0) | 6 (18) |
| Headache | 2 (6) | 4 (12) |
| Back pain | 2 (6) | 4 (12) |
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 labeling: Hypocalcemia [see Warnings and Precautions (5.1) ] Upper Gastrointestinal Bleeding [see Warnings and Precautions (5.2) ] Hypotension, Worsening Heart Failure and/or Arrhythmias [see Warnings and Precautions (5.3) ] Adynamic Bone Disease [see Warnings and Precautions (5.4) ] The most common adverse reactions (i.e., ≥ 25%) associated with cinacalcet were nausea and vomiting. (6) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 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. Secondary Hyperparathyroidism in Patients with Chronic Kidney Disease on Dialysis In three double-blind, placebo-controlled clinical trials, 1126 patients with CKD on dialysis received study drug (656 cinacalcet, 470 placebo) for up to 6 months. The most frequently reported adverse reactions are listed in Table 1. …
Source: FDA drug label, Aurobindo Pharma Limited, effective April 2, 2026 (SPL set 200390f2-7dad-4ecc-a086-c29e18525c01), via openFDA; the full label on DailyMed
What do FAERS reports show?
48,765 reports list cinacalcet among the medicines taken, each a report of something that happened, not proof the medicine caused it; 2,911 are coded as a death and 12,144 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. Reports rose sharply in 2018 (12,771, against a median of 673 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 18 reactions below, 9 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?
- Cinacalcet: 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