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Agrylin

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Agrylin

Agrylin Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Agrylin (anagrelide hydrochloride) is 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. It is a platelet-reducing agent. This medication is available in generic form. Common side effects include headache, diarrhea, weakness, nausea, and dizziness.

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 breast-feeding.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Agrylin in Detail - Patient Information: Side Effects

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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Agrylin Overview - Patient Information: Side Effects

SIDE EFFECTS: Headache, diarrhea, weakness, nausea, gas, loss of appetite, and dizziness may occur. If any of these effects persist or worsen, contact your doctor or pharmacist promptly.

To avoid dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: unusual bleeding/bruising, black stools, swelling of the ankles/feet, rapid/difficult breathing, stomach/abdominal pain, unusual tiredness, change in the amount of urine, pink/bloody urine, vomit that looks like coffee grounds.

Get medical help right away if you have any very serious side effects, including: chest/jaw/left arm pain, confusion/mental changes, severe dizziness, fainting, fast/irregular/pounding heartbeat, seizures, slurred speech, vision changes, weakness on one side of the body.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Agrylin (Anagrelide)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Agrylin FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Analysis of the adverse events in a population consisting of 942 patients in 3 clinical studies diagnosed with myeloproliferative diseases of varying etiology (ET: 551; PV: 117; OMPD: 274) has shown that all disease groups have the same adverse event profile. While most reported adverse events during anagrelide therapy have been mild in intensity and have decreased in frequency with continued therapy, serious adverse events were reported in these patients. These include the following: congestive heart failure, myocardial infarction, cardiomyopathy, cardiomegaly, complete heart block, atrial fibrillation, cerebrovascular accident, pericarditis, pericardial effusion, pleural effusion, pulmonary infiltrates, pulmonary fibrosis, pulmonary hypertension, pancreatitis, gastric/duodenal ulceration, and seizure.

Of the 942 patients treated with anagrelide for a mean duration of approximately 65 weeks, 161 (17%) were discontinued from the study because of adverse events or abnormal laboratory test results. The most common adverse events for treatment discontinuation were headache, diarrhea, edema, palpitations, and abdominal pain. Overall, the occurrence rate of all adverse events was 17.9 per 1,000 treatment days. The occurrence rate of adverse events increased at higher dosages of anagrelide.

The most frequently reported adverse reactions to anagrelide (in 5% or greater of 942 patients with myeloproliferative disease) in clinical trials were:

Headache ...............................43.5%
Palpitations.............................26.1%
Diarrhea..................................25.7%
Asthenia .................................23.1%
Edema, other ..........................20.6%
Nausea ...................................17.1%
Abdominal Pain .....................16.4%
Dizziness ................................15.4%
Pain, other ..............................15.0%
Dyspnea..................................11.9%
Flatulence ...............................10.2%
Vomiting ................................9.7%
Fever ......................................8.9%
Peripheral Edema ...................8.5%
Rash, including urticaria ........8.3%
Chest Pain ..............................7.8%
Anorexia.................................7.7%
Tachycardia ............................7.5%
Pharyngitis .............................6.8%
Malaise ...................................6.4%
Cough .....................................6.3%
Paresthesia..............................5.9%
Back Pain ...............................5.9%
Pruritus ...................................5.5%
Dyspepsia ...............................5.2%

Adverse events with an incidence of 1% to < 5% included:

Body as a Whole System: Flu symptoms, chills, photosensitivity.

Cardiovascular System: Arrhythmia, hemorrhage, hypertension, cardiovascular disease, angina pectoris, heart failure, postural hypotension, thrombosis, vasodilatation, migraine, syncope.

Digestive System: Constipation, GI distress, GI hemorrhage, gastritis, melena, aphthous stomatitis, eructation.

Hemic & Lymphatic System: Anemia, thrombocytopenia, ecchymosis, lymphadenopathy. Platelet counts below 100,000/μL occurred in 84 patients (ET: 35; PV: 9; OMPD: 40), reduction below 50,000/μL occurred in 44 patients (ET: 7; PV: 6; OMPD: 31) while on anagrelide therapy. Thrombocytopenia promptly recovered upon discontinuation of anagrelide.

Hepatic System: Elevated liver enzymes were observed in 3 patients (ET: 2; OMPD: 1) during anagrelide therapy. Musculoskeletal System: Arthralgia, myalgia, leg cramps.

Nervous System: Depression, somnolence, confusion, insomnia, nervousness, amnesia.

Nutritional Disorders: Dehydration.

Respiratory System: Rhinitis, epistaxis, respiratory disease, sinusitis, pneumonia, bronchitis, asthma.

Skin and Appendages System: Skin disease, alopecia.

Special Senses: Amblyopia, abnormal vision, tinnitus, visual field abnormality, diplopia.

Urogenital System: Dysuria, hematuria.

Renal abnormalities occurred in 15 patients (ET: 10; PV: 4; OMPD: 1). Six ET, 4 PV and 1 with OMPD experienced renal failure (approximately 1%) while on anagrelide treatment; in 4 cases, the renal failure was considered to be possibly related to anagrelide treatment. The remaining 11 were found to have pre-existing renal impairment. Doses ranged from 1.5-6.0 mg/day, with exposure periods of 2 to 12 months. No dose adjustment was required because of renal insufficiency.

The adverse event profile for patients in three clinical trials on anagrelide therapy (in 5% or greater of 942 patients with myeloproliferative diseases) is shown in the following bar graph:

All patients with Myeloproliferative Disease (N=942)

All patients with Myeloproliferative Disease - Illustration

Postmarketing Reports

Cases of torsades de pointes, ventricular tachycardia, interstitial lung diseases (including allergic alveolitis, eosinophilic pneumonia and interstitial pneumonitis), tubulointerstitial nephritis and clinically significant hepatotoxicity have been reported (See WARNINGS, Cardiovascular, Interstitial Lung Diseases and PRECAUTIONS, Laboratory Tests).

Read the entire FDA prescribing information for Agrylin (Anagrelide) »

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Agrylin - User Reviews

Agrylin User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Agrylin sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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