Recommended Topic Related To:

Intuniv

"The U.S. Food and Drug Administration today allowed marketing of the first medical device based on brain function to help assess attention-deficit/hyperactivity disorder (ADHD) in children and adolescents 6 to 17 years old. When used as part of "...

Intuniv

Intuniv

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;
  • 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. You may report side effects to FDA at 1-800-FDA-1088.

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

SIDE EFFECTS: Drowsiness, dizziness, dry mouth, constipation, tiredness, nausea, headache, and stomach pain may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

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
(Adverse Reactions)

SIDE EFFECTS

The following serious adverse reactions are described elsewhere in the labelling:

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.

Monotherapy Trials

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.

Adjunctive Trial

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®
(N=513)
Placebo
(N=149)
Somnolencea 38% 12%
Headache 24% 19%
Fatigue 14% 3%
Abdominal pain b 11% 9%
Hypotensionc 7% 3%
Nausea 6% 2%
Lethargy 6% 3%
Dizziness 6% 4%
Irritability 6% 4%
Decreased appetite 5% 3%
Dry mouth 4% 1%
Constipation 3% 1%
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
(N=153)
Headache 21% 13%
Somnolenceb 18% 7%
Insomniac 12% 6%
Fatigue 10% 3%
Abdominal paind 10% 3%
Dizziness 8% 4%
Decreased appetite 7% 4%
Nausea 5% 3%
Diarrhea 4% 1%
Hypotensione 3% 0%
Affect lability 2% 1%
Bradycardia 2% 0%
Constipation 2% 0%
Dry mouth 2% 0%
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 studies

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
Nervous system Convulsion,
Psychiatric Agitation, anxiety, depression, nightmare
Renal Increased urinary frequency, enuresis
Respiratory Asthma
Vascular Hypertension, pallor

Post-marketing Experience

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:

General: edema, malaise, tremor

Cardiovascular: palpitations, tachycardia

Central Nervous System: paresthesias, vertigo

Eye Disorders: blurred vision

Musculo-Skeletal System: arthralgia, leg cramps, leg pain, myalgia

Psychiatric: confusion, hallucinations

Reproductive System, Male: impotence

Respiratory System: dyspnea

Skin and Appendages: alopecia, dermatitis, exfoliative dermatitis, pruritus, rash

Special Senses: alterations in taste

Read the entire FDA prescribing information for Intuniv (guanfacine) »

A A A

Intuniv - User Reviews

Intuniv User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Intuniv sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Women's Health

Find out what women really need.

advertisement
advertisement
Use Pill Finder Find it Now See Interactions

Pill Identifier on RxList

  • quick, easy,
    pill identification

Find a Local Pharmacy

  • including 24 hour, pharmacies

Interaction Checker

  • Check potential drug interactions
Search the Medical Dictionary for Health Definitions & Medical Abbreviations