Anagrelide: uses, dosing, side effects & brands
Anagrelide is a platelet-reducing agent sold in the U.S. under 2 brand and generic names, for polycythemia vera and thrombocytosis. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Platelet-Reducing Agent
- Treats
- Polycythemia Vera and Thrombocytosis
- Available as
- Capsule
- Sold as
- 2 products — Anagrelide Hydrochloride and Agrylin
- Prescription?
- Prescription only
- Generic available?
- Yes
- Half-life
- about 1.5 hours
- What the pharmacy pays
- about $33 for a 30-count supply — not your price
How anagrelide is dosed
From the FDA label for Anagrelide Hydrochloride (application ANDA076811). Other anagrelide products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
The starting dose for adults is 0.5 mg four times a day or 1 mg twice a day. (2.1) The starting dose for pediatric patients is 0.5 mg per day. (2.1) Maintain the starting dose for at least one week and then titrate to maintain target platelet counts. (2.2) Do not exceed a dose increment of 0.5 mg/day in any one week. Do not exceed 10 mg/day or 2.5 mg in a single dose. (2.2) Moderate hepatic impairment: Start with 0.5 mg per day. (2.3) 2.1 Recommended Starting Dosage Adults: The recommended starting dosage of anagrelide capsules is 0.5 mg four times daily or 1 mg twice daily. Pediatric Patients: The recommended starting dosage of anagrelide capsules is 0.5 mg daily. 2.2 Dose Titration Based Upon Platelet Response Continue the starting dose for at least one week and then titrate to reduce and maintain the platelet count below 600,000/μL, and ideally between 150,000/μL and 400,000/μL. The dose increment should not exceed 0.5 mg/day in any one week. Dosage should not exceed 10 mg/day or 2.5 mg in a single dose. Most patients will experience an adequate response at a dose of 1.5 to 3.0 mg/day. Monitor platelet counts weekly during titration then monthly or as necessary. 2.3 Dose Modifications for Hepatic Impairment In patients with moderate hepatic impairment (Child Pugh score 7-9) start anagrelide capsules therapy at a dose of 0.5 mg/day and monitor frequently for cardiovascular…
Anagrelide side effects
The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Cardiovascular Toxicity [see Warnings and Precautions (5.1)] Pulmonary Hypertension [see Warnings and Precautions (5.2)] Bleeding Risk [see Warnings and Precautions (5.3)] Pulmonary Toxicity [see Warnings and Precautions (5.4)] The most common adverse reactions (incidence ≥ 5%) are headache, palpitations, diarrhea, asthenia, edema, nausea, abdominal pain, dizziness, pain, dyspnea, cough, flatulence, vomiting, fever, peripheral edema, rash, chest pain, anorexia, tachycardia, malaise, paresthesia, back pain, pruritus, and dyspepsia. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact ANI Pharmaceuticals, Inc. at 1-855-204-1431 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Clinical Studies in Adult Patients In three single-arm clinical studies, 942 patients [see Clinical Trials (14)] diagnosed with myeloproliferative neoplasms of varying etiology (ET: 551; PV: 117; OMPN: 274) were exposed to anagrelide with a mean duration of approximately 65 weeks. Serious adverse…
Who shouldn’t take anagrelide
None. None (4)
Anagrelide drug interactions
Other PDE 3 inhibitors: Exacerbation of inotropic effects (7.2) Aspirin and Drugs that Increase Bleeding Risk: Increased risk of bleeding with concomitant use (7.3) 7.1 Drugs that Prolong QT Avoid use of anagrelide 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 (12.2)] . 7.2 PDE3 Inhibitors Anagrelide is a phosphodiesterase 3 (PDE3) inhibitor. Avoid 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)] . 7.3 Aspirin and Drugs that Increase Bleeding Risk Co-administration of single-dose or repeat-dose anagrelide and aspirin showed greater ex vivo anti-platelet aggregation effects than administration of aspirin alone [see Clinical Pharmacology (12.3)]. Results from an observational study in patients with essential thrombocythemia suggest the rate of major hemorrhagic events (MHEs) in patients treated with anagrelide is higher than in those subjects treated with another cytoreductive treatment. The majority of the major hemorrhagic events occurred in patients who were also receiving concomitant anti-aggregatory treatment (primarily, aspirin). Therefore, the potential risks of the concomitant use of anagrelide with aspirin should be assessed, particularly in patients with a high-risk profile for hemorrhage, before treatment is initiated [see Warnings and Precautions (5.3)] . Monitor patients for bleeding, particularly those receiving concomitant therapy with other drugs known to cause bleeding (e.g., anticoagulants, PDE3 inhibitors, NSAIDs, antiplatelet agents, selective serotonin reuptake inhibitors). 7.4 CYP450 Interactions CYP1A2 inhibitors: Anagrelide and its active metabolite are primarily metabolized by CYP1A2. Drugs that inhibit CYP1A2 (e.g., fluvoxamine, ciprofloxacin) could increase the exposure of anagrelide. Monitor patients for cardiovascular events and titrate doses accordingly when CYP1A2 inhibitors are co-administered. CYP1A2 inducers: CYP1A2 inducers could decrease the exposure of anagrelide. Patients taking concomitant CYP1A2 inducers (e.g., omeprazole) may need to have their dose titrated to compensate for the decrease in anagrelide exposure. CYP1A2 substrates: Anagrelide demonstrates limited inhibitory activity towards CYP1A2 in vitro and may alter the exposure of concomitant CYP1A2 substrates (e.g., theophylline, fluvoxamine, ondansetron).
Every anagrelide product we track (2)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | 70/100 | Prescription | Capsule | Generic | $33 | View → | |
| 2 | Not yet rated | Prescription | Capsule | Generic | $33 | View → |
What anagrelide pills look like
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| S063 | 0.5 mg | white | capsule | — |
| 5241;0;5;mg | 0.5 mg | gray, white | capsule | — |
| 5241;05mg | 0.5 mg | gray | capsule | — |
| 5240;1mg | 1 mg | white | capsule | — |
How long anagrelide keeps
No anagrelide label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.
Does anagrelide expire? The in-use limits and storage rules from its labelsWhat people report to the FDA about anagrelide
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 487 reports naming anagrelide, and the FDA flagged 79% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- myelofibrosis25 reports
- skin ulcer25 reports
- hypertension24 reports
- renal failure24 reports
- fatigue23 reports
- anaemia21 reports
- diarrhoea18 reports
- platelet count increased18 reports
Read these as a signal, not a rate. A report does not mean anagrelide caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
How long anagrelide stays in your system
The elimination half-life of anagrelide is about 1.5 hours. This 1.5-hour figure is for parent anagrelide, but it is misleading on its own: anagrelide's ACTIVE metabolite, 3-hydroxy anagrelide (which contributes to its platelet-lowering effect), has a longer plasma half-life of about 2.5 hours. Neither the parent nor the metabolite accumulates in plasma at clinical doses. The label reports only this single elimination phase (under the "Elimination" heading), not a separate distribution phase. Populations: the label does not restate the half-life for special groups, but exposure shifts — in elderly patients (65-75 yr) anagrelide Cmax/AUC were 36%/61% higher (while active-metabolite exposure was lower); severe renal impairment (CrCl <30 mL/min) had no significant effect on anagrelide pharmacokinetics; moderate hepatic impairment (Child-Pugh 7-9) raised anagrelide Cmax ~2-fold and total exposure ~8-fold, so it is used cautiously in liver impairment.
Anagrelide capsules — DailyMed label, §12.3 Pharmacokinetics ↗Half-life is how long the body takes to clear half a dose. It is not the same as how long a drug test can detect it, and it varies with age, kidney and liver function.
Related calculators
Frequently asked questions
What is anagrelide?
Anagrelide Hydrochloride is a platelet-reducing agent used to treat Polycythemia Vera, Thrombocytosis.
What kind of drug is anagrelide?
The FDA classifies anagrelide as a platelet-reducing agent. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
How long does anagrelide stay in your system?
The elimination half-life of anagrelide is about 1.5 hours — that is how long the body takes to clear half of a dose. This 1.5-hour figure is for parent anagrelide, but it is misleading on its own: anagrelide's ACTIVE metabolite, 3-hydroxy anagrelide (which contributes to its platelet-lowering effect), has a longer plasma half-life of about 2.5 hours. Neither the parent nor the metabolite accumulates in plasma at clinical doses. The label reports only this single elimination phase (under the "Elimination" heading), not a separate distribution phase. Populations: the label does not restate the half-life for special groups, but exposure shifts — in elderly patients (65-75 yr) anagrelide Cmax/AUC were 36%/61% higher (while active-metabolite exposure was lower); severe renal impairment (CrCl <30 mL/min) had no significant effect on anagrelide pharmacokinetics; moderate hepatic impairment (Child-Pugh 7-9) raised anagrelide Cmax ~2-fold and total exposure ~8-fold, so it is used cautiously in liver impairment. Half-life is not the same as how long a drug test can detect the drug, and it varies with age, kidney and liver function.
Can you take anagrelide with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run anagrelide against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is anagrelide sold under?
We track 2 anagrelide-containing products in the U.S.: Anagrelide Hydrochloride and Agrylin. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does anagrelide come in?
Across the brands we track, anagrelide is currently marketed as capsule, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic anagrelide?
Yes. Our catalog lists 1 generic anagrelide product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.
Cite this page
- APA
- pharmaranks. (2026, July 24). Anagrelide: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/anagrelide
- MLA
- “Anagrelide: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/anagrelide.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for anagrelide on DailyMed (NIH) ↗.