Intuniv Side Effects

Generic name: guanfacine

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

Some side effects of Intuniv 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 guanfacine: oral tablet, oral tablet extended release

Get emergency medical help if you have any of these signs of an allergic reaction while taking guanfacine (the active ingredient contained in Intuniv) 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:

• fast or slow heart rate;

• pounding heartbeats, chest tightness;

• numbness or tingling; or

• feeling like you might pass out.

Less serious side effects of guanfacine may include:

• drowsiness, dizziness, tired feeling;

• dry mouth;

• constipation;

• stomach pain;

• weight gain;

• headache; or

• feeling irritable.

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 guanfacine: oral tablet, oral tablet extended release

General

Guanfacine (the active ingredient contained in Intuniv) is generally well-tolerated. In a study of 580 hypertensive patients, only 7% withdrew due to adverse side effects. In addition, most side effects were mild, dose-related, and resolved over time.

Nervous system

Nervous system side effects have included fatigue or a sedative effect and dizziness in 33% and 15% of patients, respectively. After one year of therapy, the incidence of these side effects falls to 6% and 1%, respectively. Headaches occur in less than 5% of patients. Nervous system side effects associated with the extended-release formulation have included somnolence (38%), fatigue (14%), headache (24%), lethargy (6%), dizziness (6%), and postural dizziness (less than 2%).

Gastrointestinal

Gastrointestinal side effects have included dry mouth in up to 60% of patients. Constipation has been associated with the use of this drug in 14% of patients. After one year of therapy the incidence of dry mouth and constipation averages 15% and 3%, respectively. Gastrointestinal side effects associated with the extended-release formulation have included dry mouth (4%), upper abdominal pain (10%), nausea (6%), and dyspepsia (less than 2%).

Cardiovascular

Cardiovascular side effects have included orthostatic hypotension and palpitations, each of which is rare. There is limited, indirect (ECG) evidence of left ventricular hypertrophy resolution after guanfacine (the active ingredient contained in Intuniv) therapy. Cardiovascular side effects associated with the extended-release formulation have included hypotension/decreased blood pressure (6%), atrioventricular block (less than 2%), bradycardia (less than 2%), and sinus arrhythmia (less than 2%) .

Genitourinary

Genitourinary complaints in male patients are limited to impotence, which is associated with higher doses (daily doses of 3 mg or more).

Metabolic

Metabolic side effects associated with the extended-release formulation have included decreased appetite (5%), and constipation (3%).

Psychiatric

Psychiatric side effects associated with the extended-release formulation have included irritability (6%)

Respiratory

Respiratory side effects associated with the extended-release formulation have included asthma (less than 2%).

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