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Cinacalcet

Cinacalcet is a calcium-sensing receptor modulator (a calcimimetic) used to treat overactive parathyroid glands and high blood calcium in certain adults.

Brand name Sensipar
Drug classes Calcium-sensing Receptor Agonist
Rx Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 31 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 7, 2026 🚨Recall on record · 7
Cinacalcet at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Cinacalcet (Sensipar) makes the parathyroid glands’ calcium sensor more sensitive, so they release less parathyroid hormone (PTH) and blood calcium falls; a mainstay for overactive parathyroid glands in adults on dialysis since about 2004 and available as a generic, it is also used for high calcium from parathyroid cancer or when parathyroid surgery is not possible. Nausea and vomiting are what people notice most and the usual reason they struggle to stay on it. The one thing to watch for is low blood calcium, so get prompt help for tingling or numbness, muscle cramps or an irregular heartbeat, because severe drops can cause seizures and life-threatening heart rhythms.

Clinical pearls

  • Take it with food or shortly after a meal, and swallow the tablets whole without chewing, crushing or splitting them.
  • Regular calcium and PTH blood tests set your dose, and calcium or vitamin D may be added if calcium drops.
  • It strongly blocks the CYP2D6 liver enzyme, so metoprolol, carvedilol, flecainide and tricyclic antidepressants may need dose changes.
  • Black or bloody stools or vomiting blood need urgent attention, especially if you have a history of ulcers or gastritis.
How you get itPrescription only
Comes asTablet
Earliest FDA record2004
Companies listing it with the FDA17
FDA label last updatedJan 16, 2023
FDA’s strongest warning (boxed)None on the label

Patient information guide A plain-language walkthrough of Cinacalcet, written from its FDA label.

What Cinacalcet is used for

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Cinacalcet tablets treat overactive parathyroid problems and high calcium in adults.

  • Secondary hyperparathyroidism in adults with chronic kidney disease on dialysis.
  • Hypercalcemia (high blood calcium) in adults with parathyroid carcinoma.
  • Hypercalcemia in adults with primary hyperparathyroidism who would qualify for parathyroidectomy (surgery to remove the gland) based on calcium levels but cannot have it.
  • Not for people with chronic kidney disease who are not on dialysis.

These uses apply to cinacalcet tablets, including the Sensipar brand.

How Cinacalcet works

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The parathyroid gland has a calcium-sensing receptor that controls how much parathyroid hormone (PTH) it makes and releases. Cinacalcet is a calcimimetic, meaning it makes this receptor more sensitive to calcium.

The gland then makes less PTH, and blood calcium falls along with it.

Cinacalcet dosage

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Cinacalcet is taken by mouth, with food or shortly after a meal. Swallow tablets whole without chewing, crushing or dividing them.

  • Dosing is started low and raised gradually every few weeks, based on blood tests.
  • The schedule differs by condition. Some people take it once daily and others take it more than once a day.
  • Your calcium, phosphorus and PTH are checked after starting or changing the dose.

Follow your prescriber's directions and the label.

Dosing details from the FDA-approved label

From the Cinacalcet prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Secondary hyperparathyroidism (HPT) in patients with chronic kidney disease (CKD) on dialysis
    • Starting dose is 30 mg once daily
    • Titrate no more frequently than every 2 to 4 weeks through sequential doses of 30 mg, 60 mg, 90 mg, 120 mg, and 180 mg once daily to target iPTH levels of 150 to 300 pg/mL
    • Maximum: 180 mg once daily
    • Take with food or shortly after a meal; swallow tablets whole; measure iPTH no earlier than 12 hours after dosing
  • Parathyroid carcinoma (PC) hypercalcemia and primary hyperparathyroidism (primary HPT) hypercalcemia
    • Starting dose is 30 mg twice daily
    • Titrate every 2 to 4 weeks through sequential doses of 30 mg twice daily, 60 mg twice daily, 90 mg twice daily, and 90 mg 3 or 4 times daily as necessary to normalize serum calcium levels
    • Maximum: 90 mg 3 or 4 times daily
    • Take with food or shortly after a meal; swallow tablets whole; measure serum calcium within 1 week after initiation or dose adjustment
  • Switching from Parsabiv (etelcalcetide) to cinacalcet tablets
    • Discontinue etelcalcetide for at least 4 weeks prior to starting cinacalcet tablets
    • Initiate cinacalcet tablets at a starting dose of 30 mg once daily
    • Ensure corrected serum calcium is at or above the lower limit of normal before initiation
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION • Cinacalcet tablets should be taken with food or shortly after a meal ( 2.1 ) • Tablets should always be taken whole and not divided ( 2.1 ) • Secondary HPT in patients with CKD on dialysis ( 2.2 ): o Starting dose is 30 mg once daily. o Titrate dose no more frequently than every 2 to 4 weeks through sequential doses of 30, 60, 90, 120, and 180 mg once daily as necessary to achieve targeted intact parathyroid hormone (iPTH) levels. o iPTH levels should be measured no earlier than 12 hours after most recent dose. • Hypercalcemia in patients with PC or severe hypercalcemia in patients with primary HPT ( 2.3 ): o Starting dose is 30 mg twice daily. o Titrate dose every 2 to 4 weeks through sequential doses of 30 mg twice daily, 60 mg twice daily, 90 mg twice daily, and 90 mg three or four times daily as necessary to normalize serum calcium levels. • Once the maintenance dose has been established, monitor serum calcium approximately monthly for patients with secondary HPT and every 2 months for patients with PC or primary HPT ( 2.4 ) 2.1 Administration Cinacalcet tablets should be taken with food or shortly after a meal. Cinacalcet tablets are administered orally and should always be taken whole and not chewed, crushed, or divided. 2.2 Secondary Hyperparathyroidism in Patients with Chronic Kidney Disease on Dialysis The recommended starting oral dose of cinacalcet tablets is 30 mg once daily. Serum calcium and serum phosphorus should be measured within 1 week and intact parathyroid hormone (iPTH) should be measured 1 to 4 weeks after initiation or dose adjustment of cinacalcet tablets [see Dosage and Administration ( 2.3 )]. Cinacalcet tablets should be titrated no more frequently than every 2 to 4 weeks through sequential doses of 30, 60, 90, 120, and 180 mg once daily to target iPTH levels of 150 to 300 pg/mL. Serum iPTH levels should be assessed no earlier than 12 hours after dosing with cinacalcet tablets. Cinacalcet tablets can be used alone or in combination with vitamin D sterols and/or phosphate binders.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Cinacalcet side effects

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The most common side effects are stomach-related.

Common side effects

  • Nausea
  • Vomiting
  • Diarrhea
  • Muscle aches or muscle spasms
  • Dizziness
  • Headache
  • Weakness or tiredness
  • Decreased appetite

When to get medical help

  • Tingling or numbness, muscle cramps or spasms, or seizures. These can be signs of low blood calcium, which can be life-threatening.
  • A fast, pounding or irregular heartbeat, or fainting. Low calcium can affect heart rhythm.
  • Black or bloody stools, vomiting blood, or severe stomach pain. These may signal stomach or upper digestive tract bleeding.
  • Severe or ongoing nausea and vomiting, which can lead to dehydration and worsening high calcium.
  • Worsening heart failure symptoms or very low blood pressure, especially if you already have heart problems.
  • Rash, hives or swelling of the face or lips, which can be signs of an allergic reaction.

Cinacalcet warnings and precautions

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  • Low blood calcium: can cause tingling, spasms, seizures and dangerous heart rhythms. Fatal cases have been reported.
  • QT prolongation: low calcium can disturb heart rhythm, especially in people with long QT syndrome or related history.
  • Seizures: low calcium lowers the seizure threshold, so people with seizure disorders need calcium monitoring.
  • Upper stomach bleeding: higher risk with gastritis, esophagitis, ulcers or severe vomiting.
  • Heart problems: rare cases of low blood pressure, worsening heart failure or arrhythmia in people with impaired heart function.
  • Adynamic bone disease: can develop if PTH is pushed too low.

Cinacalcet interactions

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Some medicines change how cinacalcet works, or how other medicines work when taken with it.

  • Strong CYP3A4 inhibitors such as ketoconazole and itraconazole raise cinacalcet levels, so dose changes and monitoring may be needed.
  • Medicines broken down by CYP2D6, such as desipramine, metoprolol, carvedilol, flecainide and most tricyclic antidepressants, may need dose changes because cinacalcet strongly blocks that enzyme.
  • Other calcium-lowering medicines can add to the risk of severe low calcium.

Interactions listed in the FDA-approved label

From the Cinacalcet prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): Cinacalcet is partially metabolized by CYP3A4, and co-administration with a strong CYP3A4 inhibitor may increase serum levels of cinacalcet. Dose adjustment of cinacalcet tablets may be required if a patient initiates or discontinues a strong CYP3A4 inhibitor; closely monitor iPTH and serum calcium.
  • CYP2D6 substrates (e.g., desipramine, metoprolol, carvedilol, flecainide, most tricyclic antidepressants): Cinacalcet is a strong inhibitor of CYP2D6, affecting concomitant medications predominantly metabolized by CYP2D6, particularly those with a narrow therapeutic index (e.g., flecainide and most tricyclic antidepressants). Dose adjustments may be required for these concomitant medications.
Read the label’s full interactions text

7 DRUG INTERACTIONS • Co-administration with a strong CYP3A4 inhibitor may increase serum levels of cinacalcet. Dose adjustment and monitoring of iPTH serum phosphorous and serum calcium may be required. (7.1) • Cinacalcet is a strong inhibitor of CYP2D6. Dose adjustments may be required for concomitant medications that are predominantly metabolized by CYP2D6. (7.2) 7.1 Strong CYP3A4 Inhibitors Cinacalcet is partially metabolized by CYP3A4. Dose adjustment of cinacalcet tablets may be required if a patient initiates or discontinues therapy with a strong CYP3A4 inhibitor (e.g., ketoconazole, itraconazole). The iPTH and serum calcium concentrations should be closely monitored in these patients [see Clinical Pharmacology (12.3) ]. 7.2 CYP2D6 Substrates Cinacalcet is a strong inhibitor of CYP2D6. 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) ] .

Drug Interactions In vitro studies indicate that cinacalcet is a strong inhibitor of CYP2D6, but not an inhibitor of CYP1A2, CYP2C9, CYP2C19, and CYP3A4. In vitro induction studies indicate that cinacalcet is not an inducer of CYP450 enzymes. Tables 5 and 6 list the findings from in vivo drug-drug interaction studies. Table 5. Effect of co-administered drugs on cinacalcet Co-administered drug and dosing regimen Cinacalcet Dose 1 Mean change in AUC (0-inf) Mean change in C max 200 mg ketoconazole twice daily for 7 days 90 mg on day 5 ↑127% ↑116% 1500 mg calcium carbonate, single dose 100 mg ↓6% ↓5% 80 mg pantoprazole daily for 3 days 90 mg on day 3 ↑1% ↓3% 2400 mg sevelamer HCl three times a day for 2 days 90 mg on day 1 with first dose of sevelamer ↓4% ↓7% 1. Single dose. Table 6.

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Before taking Cinacalcet

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  • Do not start if blood calcium is below the normal range.
  • Tell your doctor about seizures, heart rhythm problems, long QT syndrome or heart failure.
  • Mention stomach ulcers, gastritis, esophagitis or severe vomiting.
  • Moderate or severe liver impairment raises cinacalcet levels, so closer blood monitoring is needed.
  • No dose change is needed for kidney impairment.
  • Not indicated for children.
  • Pregnancy: human data are limited. Animal studies showed pup loss and lower weight gain when the mother had low calcium.
  • Breastfeeding: no human data. Cinacalcet passed into rat milk. Discuss with your doctor.
  • Older adults: similar safety and effectiveness, but some may be more sensitive.

Cinacalcet overdose

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Too much cinacalcet can cause low blood calcium. Anyone who takes too much should be monitored for signs of low calcium and treated to correct their levels. Hemodialysis is not an effective treatment because cinacalcet is highly protein bound.

What Cinacalcet does in the body

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Cinacalcet lowers PTH levels, and the drop tracks with how much drug is in the blood. PTH is lowest about 2 to 6 hours after a dose. In people with chronic kidney disease on dialysis, lowering PTH is linked to less bone turnover and bone fibrosis (scarring).

How your body processes Cinacalcet

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Peak levels occur about 2 to 6 hours after a dose, and taking it with food raises how much is absorbed. Steady levels build up within about 7 days. The terminal half-life is roughly 30 to 40 hours. The liver breaks it down mainly through CYP3A4, CYP2D6 and CYP1A2, and most of it leaves through the urine as metabolites.

How to store Cinacalcet

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Store at 25ºC (77ºF); excursions permitted from 15°C to 30ºC (59°F to 86ºF).

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

17

Supplements & herbs that interact with Cinacalcet

17 supplements and herbal products have documented interactions with Cinacalcet in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 1
  • Moderate · 7
  • Minor · 9
Every supplement checked against Cinacalcet — ranked by severity The full interaction hub: 1 major · 7 moderate · 9 minor · every one linked to its full report. Check Cinacalcet against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

Cinacalcet: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Cinacalcet — the kind of thing our pharmacy team would talk through with you at the counter.

What is cinacalcet for?

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It lowers parathyroid hormone and blood calcium. It's used in adults with secondary hyperparathyroidism on dialysis, in parathyroid carcinoma, and in primary hyperparathyroidism when surgery isn't an option. It isn't for kidney disease patients who aren't on dialysis.

How should I take it?

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Take it by mouth with food or right after a meal. Swallow it whole. Don't chew, crush or split it. Your prescriber may change your amount based on blood tests, so keep your lab appointments.

What side effects should I expect?

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Nausea and vomiting are the most common, and taking it with food helps. Diarrhea, muscle aches, dizziness and headache can also happen. If nausea or vomiting is severe or won't stop, tell your doctor.

When should I call my doctor?

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Call right away for tingling, muscle cramps or spasms, seizures, a racing or irregular heartbeat, or fainting. These can be signs of low calcium. Also call for black or bloody stools, vomiting blood, or hives and swelling.

Does cinacalcet interact with my other medicines?

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It can. Antifungals like ketoconazole and itraconazole can raise cinacalcet levels. Cinacalcet also affects medicines cleared by CYP2D6, like metoprolol, carvedilol, flecainide and many antidepressants. Tell your pharmacist about everything you take.

Is it safe in pregnancy?

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There isn't enough human data to know the risk. In animal studies, pup loss and lower weight gain occurred when the mothers had low calcium. Talk with your doctor if you're pregnant, planning pregnancy or breastfeeding.

Is Cinacalcet available over the counter?

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No. Cinacalcet is a prescription medicine: every Cinacalcet product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Cinacalcet first available?

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The earliest FDA record we hold for Cinacalcet is from 2004: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Cinacalcet was first used.

Who makes Cinacalcet?

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17 companies currently list Cinacalcet products in the FDA's NDC Directory, including Bryant Ranch Prepack, Accord Healthcare, Inc., Amgen Inc. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Cinacalcet on HelloPharmacist

Detailed data & references for Cinacalcet Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Cinacalcet forms and strengths (how it comes)

Cinacalcet is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Cinacalcet inactive ingredients by manufacturer.

Tablet

By mouth
Brands Sensipar
How this form is used
What it may be used for
  • Cinacalcet tablets and Sensipar are used for secondary hyperparathyroidism in adults with chronic kidney disease on dialysis.
  • Cinacalcet tablets and Sensipar are used for high blood calcium in adults with parathyroid carcinoma.
  • Cinacalcet tablets and Sensipar are used for high blood calcium in adults with primary hyperparathyroidism who cannot have parathyroid surgery.
Important instructions
  • Cinacalcet tablets and Sensipar are taken by mouth with food or shortly after a meal.
  • Cinacalcet tablets and Sensipar should be swallowed whole, not chewed, crushed or divided.
Available strengths 3 strengths
88 FDA-listed product records ⓘ

Cinacalcet on the U.S. market: products, makers and brands

How Cinacalcet appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

17 companies list 51 Cinacalcet product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2004. Brand names on the directory include Sensipar; the rest are generics.

1
Dose forms ⓘ
17
Labelers (makers, repackagers, distributors)
3
Brand names
51
FDA-listed product records ⓘ
2004
Earliest FDA record ⓘ

Also listed with the FDA, not a patient dose form: Powder (17) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Bryant Ranch Prepack24%
Accord Healthcare, Inc.6%
Amgen Inc6%
Amneal Pharmaceuticals LLC6%
Ascend Laboratories, LLC6%
Aurobindo Pharma Limited6%
Other makers47%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Cinacalcet is used (Medicaid data)

A general measure of how commonly Cinacalcet is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Cinacalcet is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

248,746
Medicaid prescriptions filled (Q1–Q4 2025)
$17.4M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Cinacalcet prescribed? Of the 1,601 medications we measure, Cinacalcet ranks #360 by Medicaid prescriptions — more than 78% of them.

Where Cinacalcet ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Cinacalcet product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 30 mg oral tablet is the most-dispensed Cinacalcet product — about 57% of these Medicaid prescriptions.

cinacalcet 30 MG Oral Tablet Most dispensed

141,379 Medicaid prescriptions (Q1–Q4 2025) 57% of Cinacalcet prescriptions shown $9.9M gross reimbursement (before rebates) ≈ $70 per prescription (gross)

Summed across the 12 of 61 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 432402

cinacalcet 60 MG Oral Tablet

67,636 Medicaid prescriptions (Q1–Q4 2025) 27% of Cinacalcet prescriptions shown $5M gross reimbursement (before rebates) ≈ $74 per prescription (gross)

Summed across the 10 of 48 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 432401

cinacalcet 90 MG Oral Tablet

39,731 Medicaid prescriptions (Q1–Q4 2025) 16% of Cinacalcet prescriptions shown $2.5M gross reimbursement (before rebates) ≈ $64 per prescription (gross)

Summed across the 8 of 49 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 432400

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Cinacalcet, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 30 of 158 listed Cinacalcet NDCs with Medicaid activity.

Compare Cinacalcet products

A representative set of FDA-listed product records for Cinacalcet — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 51 of 51 products — FDA National Drug Code Directory. See every product, package size and price: browse all 51 Cinacalcet NDCs →

Cinacalcet recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list 8 Cinacalcet recalls since July 2021, covering 20 product listings. Seven of them are still ongoing or began in the last six months and are listed first. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Ongoing Class II Jun 29, 2026 · Cipla USA, Inc.
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
  • Cinacalcet Hydrochloride Tablets, 90 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warre… Lots: Lot #: 5PB0563, Exp 4/30/2027 FDA record D-0676-2026 →
  • Cinacalcet Hydrochloride Tablets, 60 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warre… Lots: Lot #: 5PB0165, 5PB0166, Exp 1/31/2027; 5PB0552, Exp 4/30/2027; 5PB0642, 5PB0643, 5PB0644, Exp 6/30/2027 FDA record D-0675-2026 →
  • Cinacalcet Hydrochloride Tablets, 30 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warre… Lots: Lot #: 5PB0465, 5PB0466, 5PB0557, Exp 4/30/2027; 5PB0629, 5PB0630, 5PB0633, 5PB0637, 5PB0638, Exp 6/30/2027 FDA record D-0661-2026 →
Ongoing Class II Jun 4, 2026 · Amgen, Inc.
CGMP Deviations
  • Sensipar (cinacalcet) Tablets, 90mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks, CA 91320-1799, Made in Japan. NDC 55513-075-30 Lots: Lot #: 1157056, Exp. Date 02/29/2028 FDA record D-0616-2026 →
  • Sensipar (cinacalcet) Tablets, 60mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks ,CA 91320-1799, Made in Japan. NDC 55513-074-30 Lots: Lot #: 1157055, Exp. Date 1/31/2028 FDA record D-0614-2026 →
  • Sensipar (cinacalcet) Tablets, 30mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks ,CA 91320-1799, Made in Japan. NDC 55513-073-30 Lots: Lot#: 1156858, Exp. Date 12/31/2027. FDA record D-0613-2026 →
Ongoing Class II Mar 16, 2026 · Cipla USA, Inc.
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
  • Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300,… Lots: Lot, expiry: 4PB0224, exp March-2026; 4PB0505, 4PB0506, 4PB0507, exp September-2026; 5PB0564, exp April-2027 FDA record D-0451-2026 →
  • Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300,… Lots: Lot, expiry: 4PB0215, 4PB0216, exp March-2026; 4PB0515, 4PB0516, exp September-2026; 4PB0517, exp September-2026; 5PB0167, exp January-2027 FDA record D-0450-2026 →
  • Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300,… Lots: Lot, expiry: Lot 4PB0526, 4PB0527, 4PB0528, exp September-2026; Lot 5PB0173, exp January-2027 FDA record D-0449-2026 →
Ongoing Class II Nov 14, 2025 · Cipla USA, Inc.
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
  • Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-412-02 Lots: Lot 5PB0183, exp 1/31/2027 FDA record D-0226-2026 →
  • Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-411-02 Lots: Lot 5PB0164, exp 1/31/2027 FDA record D-0225-2026 →
  • Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-410-02 Lots: Lot, expiry: Lot 4PB0109, exp 1/31/2026; Lot 5PB0172, exp 1/31/2027 FDA record D-0224-2026 →
Ongoing Class II Jul 9, 2025 · Strides Pharma, Inc.
Failed Dissolution Specifications.
  • Cinacalcet Tablets 90 mg, 30-count bottles, Rx only, Manufactured by: Strides Pharma Science Ltd. Puducherry, India; Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816, NDC 64380-885-04 Lots: Lot #: 7715893A, Exp. Date 12/31/2027 FDA record D-0546-2025 →
Ongoing Class II Oct 10, 2024 · ACCORD HEALTHCARE, INC.
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
  • Cinacalcet Tablets, 90 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-442-10, b) 90 Tablets per bottle, NDC: 16729-442-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured… Lots: a) Lot #: Expiry Date: M2303264 01/2026 b) Lot #: Expiry Date: M2306979 04/2026 FDA record D-0032-2025 →
  • Cinacalcet Tablets, 60 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-441-10, b) 90 Tablets per bottle, NDC: 16729-441-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured… Lots: a) Lot #: Expiry Date: M2204481 02/2025 M2212389 08/2025 M2214271 09/2025 M2215970 10/2025 M2216458 10/2025 b) Lot #: Expiry Date: M2212869 08/2025 M2216362 09/2025 M2215969 10/2025 FDA record D-0031-2025 →
  • Cinacalcet Tablets 30 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-440-10, b) 90 Tablets per bottle, NDC: 16729-440-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured… Lots: a) Lot #: Expiry Date: M2118190 11/2024 M2201091 11/2024 M2206241 11/2024 M2206451 04/2025 M2208674 06/2025 M2213850 08/2025 M2215221 09/2025 M2216236 11/2025 M2217098 11/2025 M2300664 11/2025 b) Lot #: Expiry Date: M2210808 06/2025 M22122… FDA record D-0030-2025 →
Ongoing Class II Oct 9, 2024 · Dr. Reddy's Laboratories, Inc.
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
  • Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India., NDC 43598-369-30. Lots: Lot# T2201443, Exp 03/2025; T2300664, Exp 12/2025. FDA record D-0028-2025 →
  • Cinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-368-30. Lots: Lot# T2200698, Exp 01/2025; T2201444, Exp 03/2025; T2202827, Exp 06/2025; T2300531, Exp 12/2025; T2301696, Exp 02/2026; T2304726, Exp 08/2026; T2400480, Exp 11/2026. FDA record D-0027-2025 →
  • Cinacalcet Tablets, 30 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-367-30. Lots: Lot# T2200120, T2200121, T2200119, T2200116, T2200118, T2200117, Exp 11/2024; T2200695, T2200694, T2200696, T2200697, Exp 01/2025; T2201426, T2201428, T2201432, T2201427, T2201430, T2201429, T2201431, Exp 03/2025; T2202743, T2202742, T2202… FDA record D-0026-2025 →
Class II Jan 18, 2024 · Completed · SUN PHARMACEUTICAL INDUSTRIES INC
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
  • Cinacalcet Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259… Lots: Lot #: DNE0702A, Exp. 06/30/2026 FDA record D-0263-2024 →

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Cinacalcet RxCUI 407990 1 dose form · 3 strengths
  1. Dose form (SCDF) Oral Tablet RxCUI 438654 In current FDA listings
    Clinical drug / strength (SCD) 30 MG RxCUI 432402 60 MG RxCUI 432401 90 MG RxCUI 432400

Look up RxCUI 407990 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Cinacalcet costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Tablet, Film Coated · Oral 30 mg $0.411 per tablet NDC details & price history
Tablet, Film Coated · Oral 60 mg $0.758 per tablet NDC details & price history
Tablet, Film Coated · Oral 90 mg $1.000 per tablet NDC details & price history
Tablet · Oral 30 mg $0.411 per tablet NDC details & price history
Tablet · Oral 60 mg $0.766 per tablet NDC details & price history
Tablet, Coated · Oral 30 mg $26.19 per tablet NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Cinacalcet brand names

Cinacalcet is sold under one brand name in the FDA directory — Sensipar. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Sensipar

Who makes Cinacalcet: manufacturers and labelers

17 companies list Cinacalcet products with the FDA. By number of product records, the largest are Bryant Ranch Prepack, Accord Healthcare, Inc., Amgen Inc. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Bryant Ranch Prepack 12 Accord Healthcare, Inc. 3 Amgen Inc 3 Amneal Pharmaceuticals LLC 3 Ascend Laboratories, LLC 3 Aurobindo Pharma Limited 3 Camber Pharmaceuticals, Inc. 3 Cipla USA Inc. 3 Exelan Pharmaceuticals Inc. 3 Strides Pharma Science Limited 3 Sun Pharmaceutical Industries, Inc. 3 XLCare Pharmaceuticals Inc. 3 Dr. Reddys Laboratories Inc 2 American Health Packaging 1 AvPAK 1 Major Pharmaceuticals 1 Remedyrepack Inc. 1

Cinacalcet drug class (RxNorm)

Cinacalcet belongs to the Calcium-sensing Receptor Agonist class.

Pharmacologic class Calcium-sensing Receptor Agonist
Drug family (ATC) Other anti-parathyroid agents
How it works Increased Calcium-sensing Receptor Sensitivity

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Cinacalcet page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jan 16, 2023
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Cinacalcet.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Cinacalcet after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
31
Finished products in the current FDA directory
51
Companies listing them (makers, repackagers, distributors)
17
FDA labeler codes behind them ⓘ
19
Linked representative label ⓘ
XLCare Pharmaceuticals Inc.
Linked label effective
Jan 16, 2023
Composite sections available
21
Linked SPL Set ID
ff0b9500-085a-4e1e-a2e4-fd918ed70b2e
Linked SPL Document ID
f26f3bd0-cfac-0d57-e053-2995a90aa96a
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. XLCare Pharmaceuticals Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →