Aloxi Side Effects

Generic name: palonosetron

Note: This document contains side effect information about palonosetron. Some of the dosage forms listed on this page may not apply to the brand name Aloxi.

Some side effects of Aloxi may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to palonosetron: oral capsule

Get emergency medical help if you have any of these signs of an allergic reaction while taking palonosetron (the active ingredient contained in Aloxi) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects of palonosetron may include:

• headache;

• constipation; or

• tired feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to palonosetron: intravenous solution, oral capsule

Cardiovascular

Cardiovascular side effects have been reported rarely. Bradycardia, hypotension, and nonsustained tachycardia have been reported in approximately 1% of patients in clinical trials. Hypertension, myocardial ischemia, extrasystoles, sinus tachycardia, sinus arrhythmia, supraventricular extrasystoles, and QT prolongation have been reported in less than 1% of patients. In many cases, causality was unclear.

Dermatologic

Dermatological side effects including allergic dermatitis (less than 1%) and rash (less than 1%) have been rarely reported.

Gastrointestinal

Gastrointestinal side effects have included constipation (2% to 5% or greater ) and diarrhea (1%). Appetite decrease, dyspepsia, abdominal pain, dry mouth, hiccups, and flatulence have been reported by less that 1% of patients in clinical trials.

General

General side effects have included reports of headache (2% to 9% or greater) and weakness (1%). Fatigue, fever, hot flash, and flu-like syndrome have been reported by less than 1% of patients in clinical trials.

Hepatic

Hepatic side effects occurred mainly in patients receiving highly emetogenic chemotherapy.

Hepatic side effects including transient, asymptomatic increases in AST and/or ALT and bilirubin have been reported in less than 1% of patients.

Metabolic

Metabolic side effects have included hyperkalemia (1%), electrolyte fluctuations, hyperglycemia, metabolic acidosis, and glycosuria.

Genitourinary

Genitourinary side effects have included urinary retention (less than 1%).

Psychiatric

Psychiatric side effects have included anxiety (1% to 2% or greater), anorexia (less than 1%), and euphoric mood (less than 1%).

Nervous system

Nervous system side effects including headache (2% to 9% or greater) and dizziness (1% to 2% or greater) have been reported. Insomnia, somnolence, hypersomnia, and paresthesia have been reported in less than 1% of patients.

Musculoskeletal

Musculoskeletal side effects have rarely included arthralgia (less than 1%).

Ocular

Ocular side effects including eye irritation and amblyopia have been reported in less than 1% of patients.

Local

Local side effects have included very rare cases of injection site reactions (burning, induration, discomfort, and pain) during postmarketing experience.

Other

Other side effects including fatigue and asthenia have been reported in greater than or equal to 2% of patients. Motion sickness, tinnitus, vein discoloration, and vein distention have been reported in less than 1% of patients.

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