Abarelix Side Effects

Please note - some side effects for Abarelix 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 Abarelix - for the Consumer

Abarelix

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 Abarelix:

Back pain; breast enlargement; breast or nipple pain or tenderness; constipation; diarrhea; dizziness; general pain; headache; hot flashes; nausea; pain, swelling, or redness at the injection site; sleep problems; tiredness; upper respiratory tract infection.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; lightheadedness; fainting; warmth; redness; swelling of the mouth, face, eyelids, lips, tongue, or throat); change in heart rate; cough; dark urine; difficulty or pain when going to the bathroom; fainting; fever; frequently needing to go to the bathroom; pale stools; shortness of breath; stomach pain; swelling of the hands, legs, or feet; unusual tiredness; yellowing of eyes or skin.

Side Effects by Body System

Endocrine

Endocrine side effects have included hot flushes (79%), sleep disturbance (44%), breast enlargement (30%), and breast pain/nipple tenderness (20%) as pharmacological consequences of androgen deprivation.

General

General side effects including pain (31%) and fatigue (10%) have been reported.

Musculoskeletal

Musculoskeletal side effects including back pain (17%) have been reported.

Cardiovascular

Physicians should carefully consider whether the risks of abarelix outweigh the benefits in patients with baseline QTc values >450 msec and in patients taking class IA or class III antiarrhythmic medications.

Cardiovascular side effects including peripheral edema (15%) and prolongation of the QT interval have been reported.

Gastrointestinal

Gastrointestinal side effects including constipation (15%), diarrhea (11%), and nausea (10%) have been reported.

Nervous system

Nervous system side effects including dizziness (12%) and headache (12%) have been reported.

Respiratory

Respiratory side effects including upper respiratory tract infection (12%) have been reported.

Genitourinary

Genitourinary side effects including dysuria (10%), micturition frequency (10%), urinary retention (10%), and urinary tract infection (10%) have been reported.

Hypersensitivity

Hypersensitivity side effects including immediate-onset allergic reactions (3.7%), sometimes resulting in hypotension and syncope, have been reported to have occurred after administration of abarelix.

The allergic reaction included urticaria, pruritus, hypotension, and syncope.

Immediate-onset reactions have been reported to have occurred following any administration of abarelix, including the initial dose. The cumulative risk for such a reaction increases with the duration of treatment.

Following each injection of abarelix, patients should be observed for at least 30 minutes in the office. If an allergic reaction associated with hypotension and/or syncope does occur, supportive measures such as leg elevation, oxygen, IV fluids, antihistamines, corticosteroids, and epinephrine should be administered as needed.

Hepatic

Hepatic side effects including clinically meaningful increases in serum transaminases have been reported in a small percentage of patients.

Hematologic

Hematologic side effects including slight decreases in hemoglobin and mean increases in serum triglycerides of approximately 10% have been reported.

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