Drugs › Calcium-sensing receptor agonist
Brand name · Cinacalcet hydrochloride
Sensipar: adverse event reports filed with FDA
40,949 reports list it as a suspect or interacting product, 2004–2026. Class: Calcium-sensing receptor agonist.
- 40,949
- reports as suspect product
- 0.2% of all reports · about 1,834 a year
- 14
- reports, 12 months to June 2026
- 28 in the 12 months before
- 30.5%
- marked serious by the reporter
- 35.7% across the class
- 3.8%
- record death among outcomes, as reported
- 1,564 reports · not verified by FDA
40,949 adverse event reports received by FDA list the brand name Sensipar (cinacalcet hydrochloride) as a suspect or interacting product, from March 2004 to June 2026. A further 3,300 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 14 reports listed it, down 50% from 28 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 1,834 reports a year and 0.2% of the 20,646,523 reports in the database, and 87.1% of the reports for the calcium-sensing receptor agonist class. How many people take it is not in the data, so a count is not a rate of occurrence.
The reactions recorded most often are drug dose omission (21.2%), hospitalisation (16.6%) and laboratory test abnormal (10.3%). A report can list several reactions, so shares add to more than 100%; 655 different terms appear across these reports. Drug dose omission is recorded in 21.2% of these reports, with no counterpart in the median calcium-sensing receptor agonist drug (0%).
30.5% of the reports are marked serious by the reporter (35.7% across the class); 3.8% record death among the outcomes and 21.4% record hospitalisation, as reported. 34.9% of the reports came from pharmacists, and the largest patient age group is 45 to 64 (27.4%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Sensipar reports recording the termmedian drug in calcium-sensing receptor agonist
- Drug dose omissiona dose was missed21.2%8,672
- Hospitalisationadmission to hospital16.6%6,786
- Laboratory test abnormal10.3%4,212
- Off label useused for a purpose or in a way not on the label5.3%2,173
- Intentional product misusedeliberate use not as intended5.1%2,077
- Nauseafeeling sick4.8%1,952
- Malaisegeneral feeling of being unwell3.6%1,467
- Adverse drug reactiona harmful or unpleasant reaction reported to a medicine3.5%1,436
- Deaththe patient died; cause not stated by this term3.4%1,389
- Vomitingbeing sick3.1%1,263
- Diarrhoealoose or frequent stools2.2%883
- Abdominal discomfortstomach discomfort1.8%723
- Decreased appetitereduced appetite1.7%710
- Muscle spasmsmuscle cramps1.3%548
- Abdominal pain upperupper stomach pain1.2%479
- Unevaluable eventthe event could not be assessed1.2%474
- Blood parathyroid hormone increased1.1%464
- Adverse eventan unwanted medical event, type not specified1.1%434
- Dizzinesslight-headedness or unsteadiness1%403
- Hypotensionlow blood pressure0.9%358
- Blood parathyroid hormone abnormal0.8%334
- Blood calcium decreased0.8%326
- Fatiguetiredness0.7%307
- Drug ineffectivethe medicine did not work as expected0.7%304
- Hypophagia0.7%301
- Pruritusitching0.7%282
- Hospice care0.6%265
- Constipationconstipation0.6%264
- Headachehead pain0.6%264
- Paraesthesiatingling or pins and needles0.6%253
Top 30 of 655 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 5 drugs in the calcium-sensing receptor agonist class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 47,026 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 98.6% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Hyperparathyroidism secondary | 16,223 | 39.6% |
| Hyperparathyroidism | 308 | 0.8% |
| Hyperparathyroidism primary | 177 | 0.4% |
| End stage renal disease | 135 | 0.3% |
| Chronic kidney disease | 130 | 0.3% |
| Hypercalcaemia | 95 | 0.2% |
The indication field is filled in by the reporter and is often blank; shares are of all 40,949 reports.
In context
| Measure | Sensipar | Calcium-sensing receptor agonist | All reports |
|---|---|---|---|
| Reports as suspect product | 40,949 | 47,026 | 20,646,523 |
| Share of that pool | — | 87.1% | 0.2% |
| Reports, latest 12 months | 14 | — | 1,332,454 |
| Marked serious | 30.5% | 35.7% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 38 | 53 | 91 |
| Hospitalisation recorded, per 1,000 reports | 214 | 232 | 213 |
| Consumer-filed share | 31.8% | 28.5% | 45.8% |
| Top term, share of reports | Drug dose omission 21.2% | median 0% | 0.8% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Other drugs in the calcium-sensing receptor agonist class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Cinacalcet hydrochloride | generic | 2,226 | 102 | 92.9% |
| Parsabiv | brand | 2,190 | 14 | 33.9% |
| Cinacalcet | generic | 1,093 | 94 | 84.8% |
| Etelcalcetide | generic | 568 | 16 | 98.4% |
Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.
Questions about Sensipar reports
How many adverse event reports has FDA received for Sensipar?
40,949 reports list Sensipar as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 14 of them arrived in the latest 12 months. Another 3,300 list it only as a concomitant medication.
What reactions are recorded in Sensipar reports?
drug dose omission (21.2%), hospitalisation (16.6%), laboratory test abnormal (10.3%), off label use (5.3%) and intentional product misuse (5.1%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Sensipar was responsible.
How serious are the reports?
30.5% are marked serious by the reporter. Among the outcomes recorded, 3.8% of reports include death and 21.4% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
pharmacist (34.9%), consumer or non-health professional (31.8%) and other health professional (28.1%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Sensipar rising?
14 reports in the 12 months to June 2026, down 50% from 28 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Sensipar was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Sensipar?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Sensipar as a suspect or interacting product; reports listing it only as a concomitant medication (3,300) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.