"Jan. 21, 2013 -- The number of children with ADHD is rising rapidly, according to a study of more than 840,000 California children.
While the research findings echo those of nationwide studies, the new study is stronger than some other stud"...
Intuniv Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Intuniv (guanfacine) is used to treat attention deficit hyperactivity disorder (ADHD) in patients older than 6 years of age, as part of a total treatment plan including psychological, educational, and social measures. Unlike other drugs used to treat ADHD, it is not a stimulant. Common side effects include drowsiness, dizziness, dry mouth, constipation, tiredness, nausea, headache, and stomach pain.
Intuniv is an extended-release tablet dosed once daily. Starting dose is 1 mg/day, and the maintenance dose is in the range of 1-4 mg once daily, depending on clinical response and tolerability. Intuniv may interact with valproic acid, azole antifungals, rifamycins, antihistamines, anti-seizure drugs, medicine for sleep or anxiety, muscle relaxants, narcotic pain relievers, psychiatric medicines, or cough-and-cold and other over-the-counter products that may contain drowsiness-causing ingredients. During pregnancy, Intuniv should be used only when prescribed. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.
Our Intuniv (guanfacine) 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.
Intuniv 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:
- fast or slow heart rate;
- pounding heartbeats, chest tightness;
- numbness or tingling; or
- feeling like you might pass out.
Less serious side effects may include:
- drowsiness, dizziness, tired feeling;
- dry mouth;
- stomach pain;
- weight gain;
- headache; or
- feeling irritable.
Read the entire detailed patient monograph for Intuniv (guanfacine) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Intuniv Overview - Patient Information: Side Effects
To lower your risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute.
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 immediately if any of these unlikely but serious side effects occur: severe dizziness, slow heartbeat, fainting, mental/mood changes (such as depression, hallucinations).
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: 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 Intuniv (guanfacine)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Intuniv FDA Prescribing Information: Side Effects
The following serious adverse reactions are described elsewhere in the labelling:
- Hypotension, bradycardia, and syncope [see WARNINGS AND PRECAUTIONS]
- Sedation and somnolence [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
A total of 2,028 subjects have been exposed to INTUNIV®while participating in clinical trials. This includes 1,533 patients from completed studies in children and adolescents, and 495 subjects in completed studies in adult healthy volunteers. The mean duration of exposure of 446 patients that previously participated in two 2-year, open-label long-term studies was approximately 10 months.
Most Common Adverse Reactions -The most commonly observed adverse reactions (incidence ≥ 5% and at least twice the rate for placebo) in the monotherapy trials (Studies 1 and 2) with INTUNIV® were: somnolence, fatigue, nausea, lethargy, and hypotension.
Adverse Reactions Leading to Discontinuation -Twelve percent (12%) of patients receiving INTUNIV® discontinued from the monotherapy clinical studies (Studies 1 and 2) due to adverse reactions, compared to 4% in the placebo group. The most common adverse reactions leading to discontinuation of INTUNIV®-treated patients from the studies were somnolence/sedation (6%) and fatigue (2%). Less common adverse reactions leading to discontinuation (occurring in approximately 1% of patients) included: hypotension, headache, and dizziness.
Most Common Adverse Reactions -The most commonly observed adverse reactions (incidence ≥ 5% and at least twice the rate for placebo) in the adjunctive trial with INTUNIV® were: somnolence, fatigue, insomnia, dizziness, and abdominal pain.
Adverse Reactions Leading to Discontinuation - In the adjunctive clinical study, 3% of patients receiving INTUNIV® discontinued due to adverse reactions, compared to 1% in the placebo group. Each adverse reaction leading to discontinuation occurred in less than 1% of INTUNIV®-treated patients.
Short Term Monotherapy Clinical Studies
Common Adverse Reactions - Two short-term, placebo-controlled, double-blind pivotal studies (Studies 1 and 2) were conducted in children and adolescents with ADHD, using fixed doses of INTUNIV®(1 mg, 2 mg, 3 mg, and 4 mg/day). The most commonly reported adverse reactions (occurring in ≥ 2% of patients) that were considered drug-related and reported in a greater percentage of patients taking INTUNIV®compared to patients taking placebo are shown in Table 1. Adverse reactions that were dose-related include: somnolence/sedation, abdominal pain, dizziness, hypotension, dry mouth and constipation.
Table 1: Percentage of Patients Experiencing Common
( ≥ 2%) Adverse Reactions in Short-Term Monotherapy Studies 1 and 2
|Adverse Reaction Term||All Doses of INTUNIV®
|Abdominal pain b||11%||9%|
|a The somnolence term includes somnolence,
sedation, and hypersomnia.
b The abdominal pain term includes abdominal pain, abdominal pain upper, and abdominal pain lower
c The hypotension term includes hypotension, orthostatic hypotension, and decreased blood pressure.
In an 8-week, placebo-controlled study in children 6-12 years of age with ADHD in which INTUNIV® was dosed once (1-4 mg/day) in the morning or evening (Study 4), the safety profile was consistent with the once daily morning dosing of INTUNIV®.
Short Term Adjunctive Clinical Study
Common Adverse Reactions - A 8-week, placebo-controlled, double-blind, dose-optimized pivotal study (Study 3) was conducted in children and adolescents aged 6-17 years with a diagnosis of ADHD who were identified as having a sub-optimal response to psychostimulants. Patients received INTUNIV® (1 mg, 2 mg, 3 mg, and 4 mg/day) or placebo, dosed in the morning or in the evening, in combination with their morning dose of psychostimulant. The most commonly reported adverse reactions (occurring in ≥ 2% of patients in the overall INTUNIV® group) that were reported in a greater percentage of patients taking INTUNIV® compared to patients taking placebo are shown in Table 2.
Table 2: Percentage of Patients Experiencing Common
( ≥ 2%) Adverse Reactions in Short-Term Adjunctive Study 3
|Adverse Reaction Term||All Doses of INTUNIV® (N=302)a||Placebo
|a The morning and evening dose groups of
INTUNIV® are combined.
b The somnolence term includes somnolence, sedation, and hypersomnia.
c The insomnia term includes insomnia, initial insomnia, and middle insomnia.
d The abdominal pain term includes abdominal pain, abdominal pain upper, and abdominal pain lower
e The hypotension term includes hypotension, orthostatic hypotension, and decreased blood pressure.
Effects on Blood Pressure and Heart Rate
In the monotherapy pediatric, short-term, controlled trials (Studies 1 and 2), the maximum mean changes from baseline in systolic blood pressure, diastolic blood pressure, and pulse were -5 mmHg, -3 mmHg, and -6 bpm, respectively, for all dose groups combined (generally one week after reaching target doses of 1 mg/day, 2 mg/day, 3 mg/day or 4 mg/day). These changes were dose dependent. Decreases in blood pressure and heart rate were usually modest and asymptomatic; however, hypotension and bradycardia can occur. Hypotension was reported as an adverse reaction for 7% of the INTUNIV® group and 3% of the placebo group. This includes orthostatic hypotension, which was reported for 1% of the INTUNIV® group and none in the placebo group. In the adjunctive trial, hypotension (3%) and bradycardia (2%) were observed in patients treated with INTUNIV® as compared to none in the placebo group. In long-term, open label studies, (mean exposure of approximately 10 months), maximum decreases in systolic and diastolic blood pressure occurred in the first month of therapy. Decreases were less pronounced over time. Syncope occurred in 1% of pediatric subjects in the clinical program. The majority of these cases occurred in the long-term, open-label studies.
Other Adverse Reactions Observed in Clinical Studies
Table 3 includes additional adverse reactions observed in short-term, placebo-controlled and long-term, open-label clinical studies not included elsewhere in section 6.1, listed by organ system.
Table 3: Other adverse reactions observed in clinical
|Body System||Adverse Reaction|
|Cardiac||Atrioventricular block, sinus arrhythmia|
|Gastrointestinal||Dyspepsia, stomach discomfort, vomiting|
|General||Asthenia, chest pain|
|Immune System Disorders||Hypersensitivity|
|Investigations||Increased alanine amino transferase, increased weight|
|Psychiatric||Agitation, anxiety, depression, nightmare|
|Renal||Increased urinary frequency, enuresis|
The following adverse reactions have been identified during post-approval use of guanfacine. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure
An open-label post-marketing study involving 21,718 patients was conducted to assess the safety of guanfacine (as the hydrochloride) 1 mg/day given at bedtime for 28 days. Guanfacine was administered with or without other antihypertensive agents. Adverse events reported in the post-marketing study at an incidence greater than 1% included dry mouth, dizziness, somnolence, fatigue, headache and nausea. The most commonly reported adverse events in this study were the same as those observed in controlled clinical trials. Less frequent, possibly guanfacine-related events observed in the post-marketing study and/or reported spontaneously, not included in section 6.1, include:
Central Nervous System: paresthesias, vertigo
Eye Disorders: blurred vision
Psychiatric: confusion, hallucinations
Reproductive System, Male: impotence
Respiratory System: dyspnea
Special Senses: alterations in taste
Read the entire FDA prescribing information for Intuniv (guanfacine) »
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