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Prescription medicine

Anagrelide Brand names: Agrylin

Anagrelide (Agrylin) is a prescription medicine with an FDA approval on record since 1997. FDA's NDC Directory lists it from 3 generic labelers, and pharmacies paid $0.729 per anagrelide HCl 0.5 mg capsule in the October 7, 2026 NADAC survey.

  • Generic listed
  • A presentation discontinued

Check it at the source: the anagrelide FDA label on DailyMed (effective April 8, 2026, Takeda Pharmaceuticals America, Inc.); the NDA 20333 record on Drugs@FDA; every anagrelide label on DailyMed.

Highlights of the record

FDA label of April 8, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026

Used for

From the label: indications and usage

AGRYLIN is indicated for the treatment of patients with thrombocythemia, secondary to myeloproliferative neoplasms, to reduce the elevated platelet count and the risk of thrombosis and to ameliorate associated symptoms including thrombo-hemorrhagic events.

Forms and strengths

  • 0.5 mg
  • 1 mg

Capsule.

On the market

Earliest approval on file
March 14, 1997 Agrylin, Takeda Pharms Usa; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals
9 first April 18, 2005; 4 with a marketed status in Drugs@FDA
Labelers listed (NDC)
4 of which 3 under generic applications, 1 under brand applications, repackagers included

Supply and safety

Pharmacy cost (NADAC)
$0.729 per capsule Anagrelide HCl 0.5 mg capsule
Shortage (FDA)
None current 2 past records
Recalls by its makers (FDA)
3 since 2013 2 Class I among all firms' recalls; latest May 11, 2022; 1 more by firms not listed as its makers
FAERS reports
2,283 through July 30, 2026

What is anagrelide used for?

From the label: indications and usage

AGRYLIN is indicated for the treatment of patients with thrombocythemia, secondary to myeloproliferative neoplasms, to reduce the elevated platelet count and the risk of thrombosis and to ameliorate associated symptoms including thrombo-hemorrhagic events. AGRYLIN is a platelet reducing agent indicated for the treatment of thrombocythemia, secondary to myeloproliferative neoplasms, to reduce the elevated platelet count and the risk of thrombosis and to ameliorate associated symptoms including thrombo-hemorrhagic events.

FDA pharmacologic class: Platelet-reducing Agent.

Source: FDA drug label (Agrylin), Takeda Pharmaceuticals America, Inc., effective April 8, 2026 (SPL set cb960074-99c1-4a73-941f-f0644a7ec219), via openFDA; the full label on DailyMed

Is there a generic for anagrelide (Agrylin)?

The FDA approved the first generic anagrelide on April 18, 2005. 9 generic applications are approved; 4 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.

FDA's NDC Directory lists anagrelide from 3 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.

  • 1997 earliest approval on file
  • 2005 first generic approved
  • red ticks recalls

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What do pharmacies pay for anagrelide (Agrylin)?

In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.729 per Anagrelide HCl 0.5 mg capsule, up 3% from $0.709 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.

  • Anagrelide HCl 0.5 mg capsule (generic)
$0.760
$0.531
January 2024October 2026
NADAC per unit, October 7, 2026
Strength and formBrand or genericPharmacy cost30 tablets, or one pen or vial12-month change
Anagrelide HCl 0.5 mg capsuleGeneric$0.729 per capsule$21.88+3%
Anagrelide HCl 1 mg capsuleGeneric$1.41 per capsule$42.40-4%

Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price

Is anagrelide in shortage?

No anagrelide presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 2 records are all marked to be discontinued, the latest updated November 19, 2025. ASHP keeps a separate shortage list, which can differ.

PresentationCompanyStatusUpdated
Anagrelide Hydrochloride, Capsule, 0.5 mg (NDC 0172-5241-60)Teva Pharmaceuticals USA, Inc.To Be DiscontinuedNovember 19, 2025
Anagrelide Hydrochloride, Capsule, 1 mg (NDC 0172-5240-60)Teva Pharmaceuticals USA, Inc.To Be DiscontinuedNovember 19, 2025

Every anagrelide presentation in the FDA shortage database

Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026

Has anagrelide been recalled?

The FDA's Enforcement Report lists 4 recalls naming anagrelide since 2013: 2 Class I (the most serious), 2 Class II, 0 Class III; 0 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of anagrelide and that holds 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.

StartedClassCompanyReason
May 11, 2022Class ITeva Pharmaceuticals USA IncFailed Dissolution Specifications- Low Out-Of-Specification results obtained during stability testing.
November 25, 2020Class ITorrent Pharma IncFailed Dissolution Specifications
September 6, 2019Class IITorrent Pharma Inc.Failed Impurities/Degradation Specifications: High Out Of Specification results for impurities detected during routine stability testing.
July 2, 2013Class IIAidapak Services, LLC not a listed makerLabeling: Label Mixup: ANAGRELIDE HCL, Capsule, 0.5 mg may have potentially been mislabeled as the following drug: ARIPiprazole, Tablet, 2 mg, NDC 59148000613 …

Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026

What does the anagrelide label say about other medicines?

The anagrelide label names 17 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name anagrelide. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Medicine namedSectionWhat the label says
Amiodaronedrug interactionsDrugs that Prolong QT Avoid use of AGRYLIN in patients taking medications that may prolong QT interval (including, but not limited to, chloroquine, clarithromycin, haloperidol, methadone, moxifloxacin, amiodarone, disopyramide, procainamide, and pimozide) [see Warnings and Precautions (5.1) and Clinical Pharmacology …
Aspirindrug interactionsDRUG INTERACTIONS Other PDE3 inhibitors: Exacerbation of inotropic effects. ( 7.2 ) Aspirin and Drugs that Increase Bleeding Risk:
Chloroquinedrug interactionsDrugs that Prolong QT Avoid use of AGRYLIN in patients taking medications that may prolong QT interval (including, but not limited to, chloroquine, clarithromycin, haloperidol, methadone, moxifloxacin, amiodarone, disopyramide, procainamide, and pimozide) [see Warnings and Precautions (5.1) and Clinical Pharmacology …
Cilostazoldrug interactionsAvoid use of drug products with similar properties such as inotropes and other PDE3 inhibitors (e.g., cilostazol, milrinone) [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.2) ].
Ciprofloxacindrug interactionsDrugs that inhibit CYP1A2 (e.g., fluvoxamine, ciprofloxacin) could increase the exposure of AGRYLIN.
Clarithromycindrug interactionsDrugs that Prolong QT Avoid use of AGRYLIN in patients taking medications that may prolong QT interval (including, but not limited to, chloroquine, clarithromycin, haloperidol, methadone, moxifloxacin, amiodarone, disopyramide, procainamide, and pimozide) [see Warnings and Precautions (5.1) and Clinical Pharmacology …
Disopyramidedrug interactionsDrugs that Prolong QT Avoid use of AGRYLIN in patients taking medications that may prolong QT interval (including, but not limited to, chloroquine, clarithromycin, haloperidol, methadone, moxifloxacin, amiodarone, disopyramide, procainamide, and pimozide) [see Warnings and Precautions (5.1) and Clinical Pharmacology …
Fluvoxaminedrug interactionsDrugs that inhibit CYP1A2 (e.g., fluvoxamine, ciprofloxacin) could increase the exposure of AGRYLIN.
Haloperidoldrug interactionsDrugs that Prolong QT Avoid use of AGRYLIN in patients taking medications that may prolong QT interval (including, but not limited to, chloroquine, clarithromycin, haloperidol, methadone, moxifloxacin, amiodarone, disopyramide, procainamide, and pimozide) [see Warnings and Precautions (5.1) and Clinical Pharmacology …
Methadonedrug interactionsDrugs that Prolong QT Avoid use of AGRYLIN in patients taking medications that may prolong QT interval (including, but not limited to, chloroquine, clarithromycin, haloperidol, methadone, moxifloxacin, amiodarone, disopyramide, procainamide, and pimozide) [see Warnings and Precautions (5.1) and Clinical Pharmacology …
Milrinonedrug interactionsAvoid use of drug products with similar properties such as inotropes and other PDE3 inhibitors (e.g., cilostazol, milrinone) [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.2) ].
Moxifloxacindrug interactionsDrugs that Prolong QT Avoid use of AGRYLIN in patients taking medications that may prolong QT interval (including, but not limited to, chloroquine, clarithromycin, haloperidol, methadone, moxifloxacin, amiodarone, disopyramide, procainamide, and pimozide) [see Warnings and Precautions (5.1) and Clinical Pharmacology …
Omeprazoledrug interactionsPatients taking concomitant CYP1A2 inducers (e.g., omeprazole) may need to have their dose titrated to compensate for the decrease in AGRYLIN exposure.
Ondansetrondrug interactionsCYP1A2 substrates: AGRYLIN demonstrates limited inhibitory activity towards CYP1A2 in vitro and may alter the exposure of concomitant CYP1A2 substrates (e.g., theophylline, fluvoxamine, ondansetron).

Every other medicine the anagrelide label names

Medicine namedSectionWhat the label says
Pimozidedrug interactions… methadone, moxifloxacin, amiodarone, disopyramide, procainamide, and pimozide) [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.2) ].
Procainamidedrug interactions… clarithromycin, haloperidol, methadone, moxifloxacin, amiodarone, disopyramide, procainamide, and pimozide) [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.2) ].
Theophyllinedrug interactionsCYP1A2 substrates: AGRYLIN demonstrates limited inhibitory activity towards CYP1A2 in vitro and may alter the exposure of concomitant CYP1A2 substrates (e.g., theophylline, fluvoxamine, ondansetron).

Check anagrelide against other medicines

Source: FDA drug label (Agrylin), Takeda Pharmaceuticals America, Inc., effective April 8, 2026 (SPL set cb960074-99c1-4a73-941f-f0644a7ec219), via openFDA; the full label on DailyMed

What do FAERS reports show for anagrelide?

The FDA Adverse Event Reporting System holds 2,283 reports that list anagrelide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 235 are coded as a death and 799 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 received each year

The most reported reactions

  • Off Label Use (a use or a product term, not a reaction)216
  • Platelet Count Increased155
  • Fatigue (named in the label)149
  • Headache (named in the label)133
  • Anaemia (named in the label)127
  • Diarrhoea (named in the label)107
  • Haemoglobin Decreased107
  • Dizziness (named in the label)97

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What next?

Anagrelide side effects
the label's list beside FAERS reports
Anagrelide shortage record
every presentation, company and date
Check an interaction
what two or more labels say about each other