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Agrylin

Last reviewed on RxList: 6/16/2017
Agrylin Side Effects Center

Last reviewed on RxList 6/16/2017

Agrylin (anagrelide hydrochloride) is a platelet-reducing agent used to treat thrombocythemia (also called thrombocytosis), a blood cell disorder in which too many platelet cells are produced, causing bleeding or blood-clotting problems. Agrylin is available in generic form. Common side effects of Agrylin include:

Tell your doctor if you have serious side effects of Agrylin including:

  • unusual bleeding or bruising,
  • black stools,
  • swelling of the ankles or feet,
  • rapid or difficult breathing,
  • stomach or abdominal pain,
  • unusual tiredness,
  • a change in the amount of urine,
  • pink or bloody urine, or
  • vomit that looks like coffee grounds.

The recommended adult starting dosage of Agrylin is 0.5 mg four times daily or 1 mg twice daily (2 capsules of 0.5 mg twice a day), for at least one week. Starting doses in pediatric patients range from 0.5 mg per day to 0.5 mg four times daily. Agrylin may interact with fluvoxamine, theophylline, birth control pills, or medications to treat congestive heart failure. Tell your doctor all medications you use. Agrylin is not recommended for use during pregnancy because of possible harm to a fetus. If you become pregnant or think you may be pregnant, inform your doctor. Consult your doctor about birth control. This drug may pass into breast milk and could have undesirable effects on a nursing infant. Consult your doctor before breastfeeding.

Our Agrylin (anagrelide hydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Agrylin Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • sudden chest pain or discomfort, rapid breathing, wheezing, dry cough or hack;
  • swelling, rapid weight gain, feeling short of breath (even with mild exertion);
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden severe headache, confusion, problems with vision, speech, or balance;
  • sudden cough, wheezing, rapid breathing, coughing up blood;
  • severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
  • pounding heartbeats or fluttering in your chest;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • fever, chills, body aches, flu symptoms; or
  • blood in your urine, painful or difficult urination.

Less serious side effects may include:

  • dizziness, mild headache;
  • nausea, vomiting, loss of appetite;
  • diarrhea, constipation, stomach pain, gas, upset stomach;
  • mild rash or itching;
  • runny or stuffy nose, sore throat;
  • numbness or tingly feeling
  • back pain; or
  • vision problems, ringing in your ears.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Agrylin (Anagrelide)

Agrylin Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of the labeling:

Clinical Trial 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] 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 reactions reported in these patients included the following: congestive heart failure, myocardial infarction, cardiomyopathy, cardiomegaly, complete heart block, atrial fibrillation, cerebrovascular accident, pericardial effusion [see WARNINGS AND PRECAUTIONS], pleural effusion, pulmonary infiltrates, pulmonary fibrosis, pulmonary hypertension, and pancreatitis. Of the 942 patients treated with anagrelide, 161 (17%) were discontinued from the study because of adverse reactions or abnormal laboratory test results. The most common adverse reactions for treatment discontinuation were headache, diarrhea, edema, palpitations, and abdominal pain.

The most frequently reported adverse reactions to anagrelide (in 5% or greater of 942 patients with myeloproliferative neoplasms) in clinical trials were listed in Table 1.

Table 1 : Adverse Reactions Reported in Clinical Studies in at least 5% of Patients

Adverse reactions AGRYLIN
(N=942) (%)
Cardiac disorders
Palpitations 26%
Tachycardia 8%
Chest pain 8%
General disorders and administration site conditions
Asthenia 23%
Edema 21%
Pain 15%
Fever 9%
Peripheral edema 9%
Malaise 6%
Gastrointestinal disorders
Diarrhea 26%
Nausea 17%
Abdominal pain 16%
Vomiting 10%
Flatulence 10%
Anorexia 8%
Dyspepsia 5%
Respiratory, thoracic and mediastinal disorders
Dyspnea 12%
Cough 6%
Skin and subcutaneous tissue disorders
Rash 8%
Pruritus 6%
Musculoskeletal and connective tissue disorders
Back pain 6%
Nervous system disorders
Headache 44%
Dizziness 15%
Paresthesia 6%

Adverse Reactions (frequency 1% to < 5%) included:

General disorders and administration site conditions: Flu symptoms, chills.

Cardiac disorders: Arrhythmia, angina pectoris, heart failure, syncope.

Vascular disorders: Hemorrhage, hypertension, postural hypotension, vasodilatation.

Gastrointestinal disorders: Constipation, gastrointestinal hemorrhage, gastritis.

Blood and lymphatic system disorders: Anemia, thrombocytopenia, ecchymosis.

Hepatobiliary disorders: Elevated liver enzymes.

Musculoskeletal and connective tissue disorders: Arthralgia, myalgia.

Psychiatric disorders: Depression, confusion, nervousness.

Nervous system disorders: Somnolence, insomnia, amnesia, migraine headache.

Respiratory, thoracic and mediastinal disorders: Epistaxis, pneumonia.

Skin and subcutaneous tissue disorders: Alopecia.

Eye disorders: Abnormal vision, diplopia.

Ear and labyrinth disorders: Tinnitus

Renal and urinary disorders: Hematuria, renal failure.

Other less frequent adverse reactions ( < 1%) were:

Cardiac disorders: Ventricular tachycardia, supraventricular tachycardia.

Nervous system disorders: Hypoesthesia.

Clinical Study in Pediatric Patients

The frequency of adverse events observed in pediatric patients was similar to adult patients. The most common adverse events observed in pediatric patients were fever, epistaxis, headache, and fatigue during the 3-month anagrelide treatment in the study. Episodes of increased pulse and decreased systolic or diastolic blood pressure beyond the normal ranges in the absence of clinical symptoms were observed. Adverse events that had been reported in these pediatric patients prior to the study and were considered to be related to anagrelide treatment based on retrospective review were; palpitations, headache, nausea, vomiting, abdominal pain, back pain, anorexia, fatigue, and muscle cramps.

Postmarketing Experience

The following adverse reactions have been identified during post-marketing use of AGRYLIN. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cases of torsades de pointes, interstitial lung diseases (including allergic alveolitis, eosinophilic pneumonia and interstitial pneumonitis) [see WARNINGS AND PRECAUTIONS], tubulointerstitial nephritis and clinically significant hepatotoxicity (including symptomatic ALT and AST elevations and elevations greater than three times the ULN) have been reported.

Other adverse events in pediatric patients reported in spontaneous reports and literature reviews include anemia, cutaneous photosensitivity and elevated leukocyte count.

Read the entire FDA prescribing information for Agrylin (Anagrelide)

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© Agrylin Patient Information is supplied by Cerner Multum, Inc. and Agrylin Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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