· Brand: Sensipar
Cinacalcet Side Effects: Common, Serious & FDA Warnings
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Based on 48,000+ FDA adverse event reports, the most-reported cinacalcet reactions include drug dose omission, hospitalisation, and laboratory test abnormal. FDA reports 16 active Class II recalls of cinacalcet, primarily for failed dissolution specifications. The FDA-approved label does not carry a boxed warning.
For information only. MedivaScan summarizes public FDA data and is not medical advice. Consult a healthcare professional before changing any medication. If you experience a serious reaction, contact your doctor or call 911.
Common Side Effects of Cinacalcet
The most-reported reactions in the FDA Adverse Event Reporting System (FAERS) for cinacalcet. Percentages reflect the share of reports mentioning each reaction; a single report may include multiple reactions. Reports indicate co-occurrence, not causation.
| Reaction | Reports | % of total |
|---|---|---|
| Drug Dose Omission | 8,740 | 18.0% |
| Hospitalisation | 6,954 | 14.3% |
| Laboratory Test Abnormal | 4,225 | 8.7% |
| Nausea | 2,396 | 4.9% |
| Vomiting | 1,641 | 3.4% |
| Malaise | 1,580 | 3.3% |
| Adverse Drug Reaction | 1,466 | 3.0% |
| Diarrhoea | 1,226 | 2.5% |
| Decreased Appetite | 860 | 1.8% |
| Abdominal Discomfort | 792 | 1.6% |
Serious Outcomes and FDA Warnings
FAERS reports flagged with a serious outcome (death, hospitalization, life-threatening, disability, or congenital anomaly), plus reactions surfaced in the FDA-approved label's Warnings section. Reports indicate co-occurrence, not causation.
| Outcome flag | Reports | % of total |
|---|---|---|
| Serious reports (any flag) | — | — |
| Hospitalization | — | — |
| Death reported as outcome FAERS outcome flag, not a reaction term. The patient was on the drug when the report was filed; causation is not established. | 2,050 | 4.2% |
From the FDA-approved label, Section 5.1: Hypocalcemia
Cinacalcet tablets lowers serum calcium and can lead to hypocalcemia [see Adverse Reactions ( 6.1 )]. Significant lowering of serum calcium can cause paresthesias, myalgias, muscle spasms, tetany, seizures, QT interval prolongation and ventricular arrhythmia. Life threatening events and fatal outcomes associated with hypocalcemia have been reported in patients treated with cinacalcet tablets, including in pediatric patients. The safety and effectiveness of cinacalcet tablets have not been established in pediatric patients [see Pediatric Use ( 8.4 )].Show full Section 5.1
Cinacalcet tablets are not indicated for patients with CKD not on dialysis [see Indications and Usage ( 1 )] . In patients with secondary HPT and CKD not on dialysis, the long-term safety and efficacy of cinacalcet tablets have not been established. Clinical studies indicate that cinacalcet-treated patients with CKD not on dialysis have an increased risk for hypocalcemia compared with cinacalcet-treated patients with CKD on dialysis, which may be due to lower baseline calcium levels. In a phase 3 study of 32 weeks duration and including 404 patients with CKD not on dialysis (302 cinacalcet, 102 placebo), in which the median dose for cinacalcet was 60 mg per day at the completion of the study, 80% of cinacalcet-treated patients experienced at least one serum calcium value < 8.4 mg/dL compared with 5% of patients receiving placebo. QT Interval Prolongation and Ventricular Arrhythmia Decreases in serum calcium can also prolong the QT interval, potentially resulting in ventricular arrhythmia. Cases of QT prolongation and ventricular arrhythmia have been reported in patients treated with cinacalcet tablets. Patients with congenital long QT syndrome, history of QT interval prolongation, family history of long QT syndrome or sudden cardiac death, and other conditions that predispose to QT interval prolongation and ventricular arrhythmia may be at increased risk for QT interval prolongation and ventricular arrhythmias if they develop hypocalcemia due to cinacalcet. Closely monitor corrected serum calcium and QT interval in patients at risk receiving cinacalcet. Seizures In clinical studies, seizures (primarily generalized or tonic-clonic) were observed in 1.4% (43/3049) of cinacalcet-treated patients and 0.7% (5/687) of placebo-treated patients. While the basis for the reported difference in seizure rate is not clear, the threshold for seizures is lowered by significant reductions in serum calcium levels. Monitor serum calcium levels in patients with seizure disorders receiving cinacalcet tablets . Concurrent Administration with Other Calcium-Lowering Drug Products Concurrent administration of cinacalcet with calcium-lowering drugs including other calcium-sensing receptor agonists could result in severe hypocalcemia. Closely monitor serum calcium in patients receiving cinacalcet and concomitant therapies known to lower serum calcium levels. Patient Education and Hypocalcemia Treatment Educate patients on the symptoms of hypocalcemia and advise them to contact a healthcare provider if they occur. If corrected serum calcium falls below the lower limit of normal or symptoms of hypocalcemia develop, start or increase calcium supplementation (including calcium, calcium-containing phosphate binders, and/or vitamin D sterols or increases in dialysate calcium concentration). Cinacalcet tablets dose reduction or discontinuation of cinacalcet tablets may be necessary [see Dosage and Administration ( 2.2 )].
From the FDA-approved label, Section 5.4: Adynamic Bone Disease
Adynamic bone disease may develop if iPTH levels are suppressed below 100 pg/mL. One clinical study evaluated bone histomorphometry in patients treated with cinacalcet tablets for 1 year. Three patients with mild hyperparathyroid bone disease at the beginning of the study developed adynamic bone disease during treatment with cinacalcet tablets. Two of these patients had iPTH levels below 100 pg/mL at multiple time points during the study.Show full Section 5.4
In three 6-month, phase 3 studies conducted in patients with CKD on dialysis, 11% of patients treated with cinacalcet tablets had mean iPTH values below 100 pg/mL during the efficacy-assessment phase. If iPTH levels decrease below 150 pg/mL in patients treated with cinacalcet tablets, the dose of cinacalcet tablets and/or vitamin D sterols should be reduced or therapy discontinued.
Cinacalcet Recalls
FDA enforcement actions matched to cinacalcet via openFDA's structured generic_name field and the NDC bridge. Ongoing recalls are listed below (verify on FDA →); closed recalls are grouped in the disclosure that follows.
| Date | Reason | Class | Quantity | Status |
|---|---|---|---|---|
| 2026-04-22 | CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit Cipla USA, Inc. | Class II | 96,096 bottles | Ongoing |
| 2026-04-22 | CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit Cipla USA, Inc. | Class II | 63,192 bottles | Ongoing |
| 2026-04-22 | CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit Cipla USA, Inc. | Class II | 113,336 bottles | Ongoing |
| 2025-12-17 | CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits. Cipla USA, Inc. | Class II | 15,744 bottles | Ongoing |
| 2025-12-17 | CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits. Cipla USA, Inc. | Class II | 63,504 bottles | Ongoing |
| 2025-12-17 | CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits. Cipla USA, Inc. | Class II | 12,576 bottles | Ongoing |
| 2025-08-06 | Failed Dissolution Specifications. Strides Pharma, Inc. | Class II | 6,672 bottles | Ongoing |
| 2024-12-11 | cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit Aurobindo Pharma USA Inc | Class II | 102576 bottles | Ongoing |
| 2024-12-11 | cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit Aurobindo Pharma USA Inc | Class II | 3336 bottles | Ongoing |
| 2024-12-11 | cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit Aurobindo Pharma USA Inc | Class II | — | Ongoing |
| 2024-11-06 | CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit Dr. Reddy's Laboratories, Inc. | Class II | 35880 bottles | Ongoing |
| 2024-11-06 | CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits. ACCORD HEALTHCARE, INC. | Class II | N/A | Ongoing |
| 2024-11-06 | CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit Dr. Reddy's Laboratories, Inc. | Class II | 10584 bottles | Ongoing |
| 2024-11-06 | CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits. ACCORD HEALTHCARE, INC. | Class II | N/A | Ongoing |
| 2024-11-06 | CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit Dr. Reddy's Laboratories, Inc. | Class II | 285126 bottles | Ongoing |
| 2024-11-06 | CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits. ACCORD HEALTHCARE, INC. | Class II | N/A | Ongoing |
Show 1 closed recall (2024 to 2024)
Includes resolved and terminated recalls matched to cinacalcet. Most recent first.
| Date | Reason | Class | Quantity | Status |
|---|---|---|---|---|
| 2024-01-31 | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. SUN PHARMACEUTICAL INDUSTRIES INC | Class II | 1,728 bottles | Resolved |
Cinacalcet Shortages
FDA-listed shortages of cinacalcet products. Strength and dosage-form level detail.
No active or recent shortages of cinacalcet are listed. We refresh this view daily.
Is Cinacalcet Safe?
Cinacalcet is FDA-approved and the label does not carry a boxed warning. The label's Warnings and Precautions section covers hypocalcemia (Section 5.1), upper gastrointestinal bleeding (Section 5.2), hypotension, worsening heart failure and/or (Section 5.3), adynamic bone disease (Section 5.4).
As with any prescription, the assessment of safety is individual; consult a clinician about your own risk profile.
FDA-Approved Indications
Cinacalcet is FDA-approved for use in the condition categories below. The FDA-approved label’s Indications and Usage section is shown verbatim.
Cinacalcet is a positive modulator of the calcium sensing receptor indicated for: Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. ( 1.1 ) Limitations of Use : Cinacalcet tablets are not indicated for use in patients with CKD who are not on dialysis Hypercalcemia in adult patients with Parathyroid Carcinoma (PC). ( 1.2 ) Hypercalcemia in adult patients with primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but who are unable to undergo parathyroidectomy. ( 1.3 ) 1.1 Secondary Hyperparathyroidism Cinacalcet tablets are indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis [see Clinical Studies ( 14.1 )].Show full Indications and Usage
Limitations of Use: Cinacalcet tablets are not indicated for use in patients with CKD who are not on dialysis because of an increased risk of hypocalcemia [see Warnings and Precautions ( 5.1 )]. 1.2 Parathyroid Carcinoma Cinacalcet tablets are indicated for the treatment of hypercalcemia in adult patients with Parathyroid Carcinoma [see Clinical Studies ( 14.2 )] . 1.3 Primary Hyperparathyroidism Cinacalcet tablets are indicated for the treatment of hypercalcemia in adult patients with primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but who are unable to undergo parathyroidectomy. [see Clinical Studies ( 14.3 )] .
Frequently Asked Questions
What are the most-reported side effects of cinacalcet?
Drug dose omission, hospitalisation, and laboratory test abnormal are among the most-reported reactions in FDA FAERS data for cinacalcet. The full ranking, with reaction counts and the share of total reports, is in the Common Side Effects table above. Reports indicate co-occurrence, not causation; consult a clinician about your specific case.
Is cinacalcet the same as Sensipar?
Cinacalcet is the generic name; Sensipar is a brand name for the same active ingredient. The active ingredient is identical; formulation and inactive ingredients may vary by manufacturer.
Has cinacalcet been recalled?
Yes. Cinacalcet has active and closed recalls on record in the FDA enforcement database. Reasons are dominated by CGMP deviations and failed dissolution specifications. See the recalls table on this page for current counts, firm names, dates, and lot quantities.
What are cinacalcet's current ongoing recalls about?
Active cinacalcet recalls are listed in the recalls table above with their class, reason, firm, and affected lots. The dominant reasons across these recalls are CGMP deviations and failed dissolution specifications. For lot numbers, distribution patterns, and the FDA enforcement record for any individual recall, follow the verify-on-FDA link from each row.
What do FDA recall classes mean?
Class I means a reasonable probability of serious adverse health consequences or death. Class II means temporary or medically reversible adverse health consequences with remote probability of serious harm. Class III means use of the product is unlikely to cause adverse health consequences. The class assignment is the FDA's, not the manufacturer's.
Data Sources & Methodology
How each section of this page is sourced, and how often the data is refreshed.
| Source | Endpoint | Refresh |
|---|---|---|
| FAERS reactions | openFDA /drug/event.json count API. Aggregated per drug per reaction term; we do not store individual reports. | Daily |
| Recalls | openFDA /drug/enforcement.json. Drugs matched via three confidence-tracked strategies: structured generic name (HIGH), NDC code bridge (MEDIUM), text token parse (LOW). Only HIGH and MEDIUM matches surface here. | 6 hours |
| Shortages | FDA Drug Shortages list. | Daily |
| Boxed warnings & label sections | openFDA /drug/label.json. Labels are stable; monthly cadence is sufficient. | Monthly |
| Condition categories | Synonym-mapped from drug_labels.indications. Methodology at /methodology/. | Per-drug |
What we do not do. We do not invent, paraphrase, or extrapolate drug claims. Every figure on this page comes from a query against an openFDA endpoint. If the data is unavailable, the section gracefully omits rather than filling the space with editorial guesswork.