Prescription medicine
Cinacalcet Brand names: Sensipar
Cinacalcet (Sensipar) is a prescription medicine with an FDA approval on record since 2004. FDA's NDC Directory lists it from 16 generic labelers, and pharmacies paid $0.411 per cinacalcet HCl 30 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the cinacalcet FDA label on DailyMed (effective April 2, 2026, Aurobindo Pharma Limited); the NDA 21688 record on Drugs@FDA; every cinacalcet label on DailyMed.
Highlights of the record
FDA label of April 2, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageCinacalcet is a positive modulator of the calcium sensing receptor indicated for: Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis.
Forms and strengths
- 30 mg
- 60 mg
- 90 mg
Film-coated tablet; tablet; coated tablet.
On the market
- Earliest approval on file
- March 8, 2004 Sensipar, Amgen; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 14 first March 8, 2018; 9 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 17 of which 16 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- September 22, 2026 Sensipar tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.411 per tablet Cinacalcet HCl 30 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 28 since 2013 0 Class I among all firms' recalls; latest June 29, 2026; 2 more by firms not listed as its makers
- FAERS reports
- 48,765 through July 30, 2026
What is cinacalcet used for?
From the label: indications and usageCinacalcet 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. […]
FDA pharmacologic class: Calcium-sensing Receptor Agonist.
Source: FDA drug label (Cinacalcet), Aurobindo Pharma Limited, effective April 2, 2026 (SPL set 200390f2-7dad-4ecc-a086-c29e18525c01), via openFDA; the full label on DailyMed
Is there a generic for cinacalcet (Sensipar)?
The FDA approved the first generic cinacalcet on March 8, 2018. 14 generic applications are approved; 9 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 3 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists cinacalcet from 16 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 2 patents for Sensipar tablets, the last expiring on September 22, 2026. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2004 earliest approval on file
- 2018 first generic approved
- 2026 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for cinacalcet (Sensipar)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.411 per Cinacalcet HCl 30 mg tablet, up 15% from $0.357 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Cinacalcet HCl 30 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Cinacalcet HCl 30 mg tablet | Generic | $0.411 per tablet | $12.34 | +15% |
| Cinacalcet HCl 60 mg tablet | Generic | $0.766 per tablet | $22.97 | +28% |
| Cinacalcet HCl 90 mg tablet | Generic | $1.06 per tablet | $31.86 | +32% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has cinacalcet been recalled?
The FDA's Enforcement Report lists 30 recalls naming cinacalcet since 2013: 0 Class I (the most serious), 30 Class II, 0 Class III; 22 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of cinacalcet and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| June 29, 2026 | Class II | Cipla USA, Inc. | cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI). |
| June 4, 2026 | Class II | Amgen, Inc. | CGMP Deviations |
| March 16, 2026 | Class II | Cipla USA, Inc. | CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit |
| November 14, 2025 | Class II | Cipla USA, Inc. | CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits. |
| July 9, 2025 | Class II | Strides Pharma, Inc. | Failed Dissolution Specifications. |
| March 7, 2025 | Class II | Slate Run Pharmaceuticals | CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits. |
| November 27, 2024 | Class II | AvKARE | CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit. |
| November 7, 2024 | Class II | Aurobindo Pharma USA Inc | cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the cinacalcet label say about other medicines?
The cinacalcet label names 6 other medicines in its interaction, contraindication or warning sections. The labels of 3 other medicines name cinacalcet. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Carvedilol | drug interactions | Dose adjustments may be required for concomitant medications that are predominantly metabolized by CYP2D6 (e.g., desipramine, metoprolol, and carvedilol) and particularly those with a narrow therapeutic index (e.g., flecainide and most tricyclic antidepressants) [see Clinical Pharmacology (12.3) ]. |
| Desipramine | drug interactions | Dose adjustments may be required for concomitant medications that are predominantly metabolized by CYP2D6 (e.g., desipramine, metoprolol, and carvedilol) and particularly those with a narrow therapeutic index (e.g., flecainide and most tricyclic antidepressants) [see Clinical Pharmacology (12.3) ]. |
| Flecainide | drug interactions | Dose adjustments may be required for concomitant medications that are predominantly metabolized by CYP2D6 (e.g., desipramine, metoprolol, and carvedilol) and particularly those with a narrow therapeutic index (e.g., flecainide and most tricyclic antidepressants) [see Clinical Pharmacology (12.3) ]. |
| Itraconazole | drug interactions | Dose adjustment of cinacalcet may be required if a patient initiates or discontinues therapy with a strong CYP3A4 inhibitor (e.g., ketoconazole, itraconazole). |
| Ketoconazole | drug interactions | Dose adjustment of cinacalcet may be required if a patient initiates or discontinues therapy with a strong CYP3A4 inhibitor (e.g., ketoconazole, itraconazole). |
| Metoprolol | drug interactions | Dose adjustments may be required for concomitant medications that are predominantly metabolized by CYP2D6 (e.g., desipramine, metoprolol, and carvedilol) and particularly those with a narrow therapeutic index (e.g., flecainide and most tricyclic antidepressants) [see Clinical Pharmacology (12.3) ]. |
Other labels that name cinacalcet
Source: FDA drug label (Cinacalcet), 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 for cinacalcet?
The FDA Adverse Event Reporting System holds 48,765 reports that list cinacalcet among the medicines taken, through July 30, 2026, 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.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other calcium-sensing receptor agonists
- the pharmacologic class, with prices and generics
- Cinacalcet side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other