Agrylin Side Effects

Generic Name: anagrelide

Please note - some side effects for Agrylin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Agrylin - for the Consumer

Agrylin

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Agrylin:

Back pain; cough; diarrhea; dizziness; drowsiness; gas; general body discomfort; headache; joint or muscle weakness; loss of appetite; nausea; stomach pain; tiredness; upset stomach; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the urine, stools, or vomit; changes in vision; chest pain, especially if sharp or crushing; depression; easy bruising or bleeding; fainting; fast or irregular heartbeat; flu-like symptoms (eg, sore throat, fever, or chills); memory loss; mental or mood changes; numbness or tingling of your skin or of an arm or leg; one-sided weakness; pounding in the chest; seizures; severe stomach pain; sudden leg pain; sudden severe headache, vomiting, dizziness, or fainting; shortness of breath; swelling of the hands, legs, or feet; trouble urinating.

Agrylin Side Effects - for the Professional

Agrylin

Analysis of the adverse events in a population consisting of 942 patients in 3 clinical studiesdiagnosed 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

Side Effects by Body System

Nervous system

Nervous system side effects have included headache (43%), dizziness (15%), asthenia (23%), paresthesia (6%), depression, somnolence, confusion, insomnia, nervousness, and amnesia.

Cardiovascular

Cardiovascular side effects have included palpitations, chest pain, tachycardia, arrhythmia, hemorrhage, cardiovascular disease, angina pectoris, heart failure, postural hypotension, thrombosis, vasodilation, migraine, and syncope.

Gastrointestinal

Gastrointestinal side effects have been reported the most frequently. These have included diarrhea (25.7%), nausea (17.1%), abdominal pain (16.4%), flatulence (10.2%), vomiting (9.7%), anorexia (7.7%), pharyngitis (6.8%), and dyspepsia (5.2%). Constipation, hemorrhage, gastritis, melena, aphthous stomatitis, and eructation have been reported in less than 5%.

General

General side effects have included edema (20%), pain (15%), fever (8%), peripheral edema (8%), anorexia (7%), malaise (6%), back pain (5%), pruritus (5%), dehydration, tinnitus, flu symptoms, chills, and photosensitivity.

Hematologic

Hematologic side effects including anemia, thrombocytopenia, ecchymosis, and lymphadenopathy have been reported.

Hepatic

Hepatic side effects have included elevated liver enzymes and at least one case of cholestatic liver failure attributed to anagrelide use.

Musculoskeletal

Musculoskeletal side effects have included arthralgia, myalgia, and leg cramps.

Respiratory

Respiratory side effects have included pharyngitis, cough, rhinitis, epistaxis, respiratory disease, sinusitis, pneumonia, bronchitis, and asthma. Postmarketing reports have included interstitial lung diseases (including allergic alveolitis, eosinophilic pneumonia and interstitial pneumonitis).

Dermatologic

Dermatologic side effects have included rash, skin disease, and alopecia.

Ocular

Ocular side effects have included amblyopia, abnormal vision, visual field abnormality, and diplopia.

Genitourinary

Genitourinary side effects have included dysuria and hematuria. Erectile dysfunction has been reported in a young man.

A 30-year-old man developed erectile dysfunction after two months of treatment with anagrelide at the initial recommended dosage. Two weeks after anagrelide was stopped, the erectile dysfunction disappeared. The patient's course was suggestive of anagrelide-induced erectile dysfunction, although a definitive cause could not be determined.

Hypersensitivity

Hypersensitivity side effects have included severe hypersensitivity pneumonitis. A 60-year-old woman developed shortness of breath, palpitations, and chest pain after one-week of treatment with anagrelide leading to respiratory failure and intubation by week five. Patient recovered after empiric treatment with methylprednisolone.

The authors of the case report of severe hypersensitivity pneumonitis suggest that patients receiving anagrelide therapy, alone or in combination with hydroxyurea, may benefit from monitoring with serial chest X-rays, pulmonary function testing, and echocardiography to detect the development of cardiomyopathy or hypersensitivity pneumonitis.

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