What the label lists and what reports show
Anagrelide side effects
Anagrelide's FDA label: “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 …” FAERS holds 2,283 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is platelet count increased (155 reports).
- 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 FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe 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.
Table 1 Adverse Reactions Reported in Clinical Studies of AGRYLIN in at least 5% of Patients
| Adverse Reactions | AGRYLIN (N=942) (%) Cardiac disorders |
|---|---|
| Palpitations | 26% |
| Tachycardia | 8% |
| Chest pain | 8% |
| Asthenia | 23% |
| Edema | 21% |
| Pain | 15% |
| Fever | 9% |
| Peripheral edema | 9% |
| Malaise | 6% |
| Diarrhea | 26% |
| Nausea | 17% |
| Abdominal pain | 16% |
| Vomiting | 10% |
| Flatulence | 10% |
| Anorexia | 8% |
| Dyspepsia | 5% |
| Dyspnea | 12% |
| Cough | 6% |
| Rash | 8% |
| Pruritus | 6% |
| Back pain | 6% |
| Headache | 44% |
| Dizziness | 15% |
| Paresthesia | 6% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe 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 Takeda Pharmaceuticals U.S.A., Inc. at 1-877-TAKEDA-7 (1-877-825-3327)- 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; …
Source: FDA drug label, 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?
2,283 reports list anagrelide among the medicines taken, 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. Of the 22 reactions below, 14 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Anagrelide: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions