72/100 · Elevated
Manufactured by Amgen Inc
Cinacalcet Hydrochloride Adverse Events: High Hospitalization and Serious Reactions
57,261 FDA adverse event reports analyzed
Last updated: 2026-05-12
CINACALCET HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Amgen Inc. Based on analysis of 57,261 FDA adverse event reports, CINACALCET HYDROCHLORIDE has a safety score of 72 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for CINACALCET HYDROCHLORIDE include DRUG DOSE OMISSION, HOSPITALISATION, LABORATORY TEST ABNORMAL, OFF LABEL USE, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CINACALCET HYDROCHLORIDE.
Cinacalcet Hydrochloride has a safety concern score of 72 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 57,261 adverse event reports for this medication, which is primarily manufactured by Amgen Inc.
The most commonly reported adverse events include Drug Dose Omission, Hospitalisation, Laboratory Test Abnormal. Of classified reports, 36.5% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. High frequency of hospitalization and death reports indicate serious safety concerns.
A significant number of reports involve laboratory test abnormalities and drug ineffectiveness. Nausea, vomiting, and abdominal discomfort are common gastrointestinal side effects.
Patients taking Cinacalcet Hydrochloride should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Cinacalcet Hydrochloride can cause hypocalcemia and hypercalcemia, and may interact with other drugs affecting calcium levels. Patients should be monitored for electrolyte imbalances and renal function. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Cinacalcet Hydrochloride received a safety concern score of 72/100 (elevated concern). This is based on a 36.5% serious event ratio across 46,234 classified reports. The score accounts for 57,261 total adverse event reports and 100 distinct reaction types. This elevated score indicates a notable proportion of serious adverse events and warrants careful monitoring.
Adverse event reports by sex: Female: 21,942, Male: 19,005, Unknown: 221. The most frequently reported age groups are age 60 (832 reports), age 58 (790 reports), age 59 (764 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 46,234 classified reports for CINACALCET HYDROCHLORIDE:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Cinacalcet Hydrochloride can cause hypocalcemia and hypercalcemia, and may interact with other drugs affecting calcium levels. Patients should be monitored for electrolyte imbalances and renal function.
If you are taking Cinacalcet Hydrochloride, here are important things to know. The most commonly reported side effects include drug dose omission, hospitalisation, laboratory test abnormal, off label use, nausea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor for signs of electrolyte imbalances and renal function regularly. Report any unusual symptoms to your healthcare provider promptly. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA closely monitors Cinacalcet Hydrochloride due to its high serious event rate. Patients should report any adverse reactions immediately and follow prescribed dosing instructions strictly.
The FDA has received approximately 57,261 adverse event reports associated with Cinacalcet Hydrochloride. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Cinacalcet Hydrochloride include Drug Dose Omission, Hospitalisation, Laboratory Test Abnormal, Off Label Use, Nausea. By volume, the top reported reactions are: Drug Dose Omission (8,738 reports), Hospitalisation (6,924 reports), Laboratory Test Abnormal (4,222 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Cinacalcet Hydrochloride.
Out of 46,234 classified reports, 16,889 (36.5%) were classified as serious and 29,345 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Cinacalcet Hydrochloride break down by patient sex as follows: Female: 21,942, Male: 19,005, Unknown: 221. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Cinacalcet Hydrochloride adverse events are: age 60: 832 reports, age 58: 790 reports, age 59: 764 reports, age 62: 756 reports, age 61: 745 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Cinacalcet Hydrochloride adverse event reports is Amgen Inc. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Cinacalcet Hydrochloride include: Intentional Product Misuse, Death, Malaise, Vomiting, Adverse Drug Reaction. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Cinacalcet Hydrochloride to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Cinacalcet Hydrochloride has a safety concern score of 72 out of 100 (elevated concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. High frequency of hospitalization and death reports indicate serious safety concerns.
Key safety signals identified in Cinacalcet Hydrochloride's adverse event data include: High number of hospitalization and death reports.. Serious reactions including hypocalcemia and hypercalcemia.. Multiple reports of renal failure and end-stage renal disease.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Cinacalcet Hydrochloride can cause hypocalcemia and hypercalcemia, and may interact with other drugs affecting calcium levels. Patients should be monitored for electrolyte imbalances and renal function. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Cinacalcet Hydrochloride.
Monitor for signs of electrolyte imbalances and renal function regularly. Report any unusual symptoms to your healthcare provider promptly.
Cinacalcet Hydrochloride has 57,261 adverse event reports on file with the FDA. A significant number of reports involve laboratory test abnormalities and drug ineffectiveness. The volume of reports for Cinacalcet Hydrochloride reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors Cinacalcet Hydrochloride due to its high serious event rate. Patients should report any adverse reactions immediately and follow prescribed dosing instructions strictly. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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