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Intuniv

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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 practice.

The data described below reflect clinical trial exposure to INTUNIV® in 2,299 patients. This includes 1,804 patients from completed studies in children and adolescents, ages 6 to 17 years and 495 patients 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.

Fixed Dose Trials

Table 3: Percentage of Patients Experiencing Most Common ( ≥ 5% and at least twice the rate for placebo) Adverse Reactions in Fixed Dose Studies 1 and 2

Adverse Reaction Term Placebo
(N=149)
INTUNIV® (mg)
1mg*
(N=61)
2mg
(N=150)
3mg
(N=151)
4mg
(N=151)
All Doses of INTUNIV®
(N=513)
Somnolencea 11% 28% 30% 38% 51% 38%
Fatigue 3% 10% 13% 17% 15% 14%
Hypotensionb 3% 8% 5% 7% 8% 7%
Dizziness 4% 5% 3% 7% 10% 6%
Lethargy 3% 2% 3% 8% 7% 6%
Nausea 2% 7% 5% 5% 6% 6%
Dry mouth 1% 0% 1% 6% 7% 4%
*The lowest dose of 1 mg used in Study 2 was not randomized to patients weighing more than 50 kg.
a The somnolence term includes somnolence, sedation, and hypersomnia.
b The hypotension term includes hypotension, diastolic hypotension, orthostatic hypotension, blood pressure decreased, blood pressure diastolic decreased, blood pressure systolic decreased).

Table 4: Adverse Reactions Leading to Discontinuation ( ≥ 2% for all doses of INTUNIV and > rate in placebo) in Fixed Dose Studies 1 and 2

Adverse Reaction Term Placebo
(N=149)
n (%)
INTUNIV® (mg)
1mg*
(N=61)
n (%)
2mg
(N=150)
n (%)
3mg
(N=151)
n (%)
4mg
(N=151)
n (%)
All Doses of INTUNIV®
(N=513)
n (%)
Total patients 4 (3%) 2 (3%) 10 (7%) 15 (10%) 27 (18%) 54 (11%)
Somnolencea 1 (1%) 2 (3%) 5 (3%) 6 (4%) 17 (11%) 30 (6%)
Fatigue 0 (0%) 0 (0%) 2 (1%) 2 (1%) 4 (3%) 8 (2%)
Adverse reactions leading to discontinuation in ≥ 2% in any dose group but did not meet this criteria in all doses combined: hypotension (hypotension, diastolic hypotension, orthostatic hypotension, blood pressure decreased, blood pressure diastolic decreased, blood pressure systolic decreased), headache, and dizziness.
* The lowest dose of 1 mg used in Study 2 was not randomized to patients weighing more than 50 kg.
a The somnolence term includes somnolence, sedation, and hypersomnia.

Table 5: Other Common Adverse Reactions ( ≥ 2% for all doses of INTUNIV and > rate in placebo) in Fixed Dose Studies 1 and 2

Adverse Reaction Term Placebo
(N=149)
INTUNIV® (mg]
1mg*
(N=61)
2mg
(N=150)
3mg
(N=151)
4mg
(N=151)
All Doses of INTUNIV®
(N=513)
Headache 19% 26% 25% 16% 28% 23%
Abdominal Paina 9% 10% 7% 11% 15% 11%
Decreased Appetite 4% 5% 4% 9% 6% 6%
Irritability 4% 5% 8% 3% 7% 6%
Constipation 1% 2% 2% 3% 4% 3%
Nightmareb 0% 0% 0% 3% 4% 2%
Enuresisc 1% 0% 1% 3% 2% 2%
Affect Labilityd 1% 2% 1% 3% 1% 2%
Adverse reactions ≥ 2% for all doses of INTUNIV and > rate in placebo in any dose group but did not meet this criteria in all doses combined: insomnia (insomnia, initial insomnia, middle insomnia, terminal insomnia, sleep disorder), vomiting, diarrhea, abdominal/stomach discomfort (abdominal discomfort, epigastric discomfort, stomach discomfort), rash (rash, rash generalized, rash papular), dyspepsia, increased weight, bradycardia (bradycardia, sinus bradycardia), asthma (asthma, bronchospasm, wheezing), agitation, anxiety (anxiety, nervousness), sinus arrhythmia, blood pressure increased (blood pressure increased, blood pressure diastolic increased), and first degree atrioventricular block.
* The lowest dose of 1 mg used in Study 2 was not randomized to patients weighing more than 50 kg.
a The abdominal pain term includes abdominal pain, abdominal pain lower, abdominal pain upper, and abdominal tenderness.
b The nightmare term includes abnormal dreams, nightmare, and sleep terror.
c The enuresis term includes enuresis, nocturia, and urinary incontinence.
d The affect lability term includes affect lability and mood swings.

Monotherapy Flexible Dose Trials

Table 6: Percentage of Patients Experiencing Most Common ( ≥ 5% and at least twice the rate for placebo) Adverse Reactions in the Monotherapy Flexible Dose Study 4

Adverse Reaction Term Placebo
(N=112)
INTUNIV®
AM
(N=107)
PM
(N=114)
All Doses of INTUNIV®
(N=221)
Somnolencea 15% 57% 54% 56%
Abdominal Painb 7% 8% 19% 14%
Fatigue 3% 10% 11% 11%
Irritability 3% 7% 7% 7%
Nausea 1% 6% 5% 5%
Dizziness 3% 6% 4% 5%
Vomiting 2% 7% 4% 5%
Hypotensionc 0% 6% 4% 5%
Decreased Appetite 3% 6% 3% 4%
Enuresisd 1% 2% 5% 4%
a The somnolence term includes somnolence, sedation, and hypersomnia.
b The abdominal pain term includes abdominal pain, abdominal pain lower, abdominal pain upper, and abdominal tenderness
c The hypotension term includes hypotension, diastolic hypotension, orthostatic hypotension, blood pressure decreased, blood pressure diastolic decreased, blood pressure systolic decreased).
d The enuresis term includes enuresis, nocturia, and urinary incontinence.

Table 7: Adverse Reactions Leading to Discontinuation ( ≥ 2% for all doses of INTUNIV and > rate in placebo) in Monotherapy Flexible Dose Study 4

Adverse Reaction Term Placebo
(N=112)
n (%)
INTUNIV®
AM
(N=107)
n (%)
PM
(N=114)
n (%)
All Doses of INTUNIV®
(N=221)
n (%)
Total patients 0 (0%) 8 (7%) 7 (6%) 15 (7%)
Somnolencea 0 (0%) 4 (4%) 3 (3%) 7 (3%)
Adverse reactions leading to discontinuation in ≥ 2% in any dose group but did not meet this criteria in all doses combined: fatigue
a The somnolence term includes somnolence, sedation, and hypersomnia.

Table 8: Other Common Adverse Reactions ( ≥ 2% for all doses of INTUNIV and > rate in placebo) in the Monotherapy Flexible Dose Study 4

Adverse Reaction Term Placebo
(N=112)
INTUNIV®
AM
(N=107)
PM
(N=114)
All Doses of INTUNIV®
(N=221)
Headache 11% 18% 16% 17%
Insomniaa 6% 8% 6% 7%
Diarrhea 4% 4% 6% 5%
Lethargy 0% 4% 3% 3%
Constipation 2% 2% 4% 3%
Dry Mouth 1% 3% 3% 3%
Adverse reactions ≥ 2% for all doses of INTUNIV and > rate in placebo in any dose group but did not meet this criteria in all doses combined: affect lability (affect lability, mood swings), increased weight, syncope/loss of consciousness (loss of consciousness, presyncope, syncope), dyspepsia, tachycardia (tachycardia, sinus tachycardia), and bradycardia(bradycardia, sinus bradycardia).
a The insomnia term includes insomnia, initial insomnia, middle insomnia, terminal insomnia, and sleep disorder.

Table 9: Percentage of Patients Experiencing Most Common ( ≥ 5% and at least twice the rate forplacebo) Adverse Reactions in the Monotherapy Flexible Dose Study 5

Adverse Reaction Term Placebo
(N=155)
All Doses of INTUNIV®
(N=157)
Somnolencea 23% 54%
Insomniab 6% 13%
Hypotensionc 3% 9%
Dry Mouth 0% 8%
Postural Dizziness 2% 5%
Bradycardiad 0% 5%
a The somnolence term includes somnolence, sedation, and hypersomnia.
b The insomnia term includes insomnia, initial insomnia, middle insomnia, terminal insomnia, and sleep disorder.
c The hypotension term includes hypotension, diastolic hypotension, orthostatic hypotension, blood pressure decreased, blood pressure diastolic decreased, blood pressure systolic decreased).
d: The bradycardia term includes bradycardia and sinus bradycardia.

There were no specific adverse reactions ≥ 2% in any treatment group that led to discontinuation in the monotherapy flexible dose study (Study 5).

Table 10: Other Common Adverse Reactions ( ≥ 2% for all doses of INTUNIV and > rate in placebo) in the Monotherapy Flexible Dose Study 5

Adverse Reaction Term Placebo
(N=155)
INTUNIV®
All Doses of INTUNIV®
(N=157)
Headache 18% 27%
Fatigue 12% 22%
Dizziness 10% 16%
Decreased Appetite 14% 15%
Abdominal Paina 8% 12%
Irritability 4% 7%
Anxietyb 3% 5%
Rashc 1% 3%
Constipation 0% 3%
Increased Weight 2% 3%
Abdominal/Stomach Discomfortd 1% 2%
Pruritus 1% 2%
Adverse reactions ≥ 2% for all doses of INTUNIV and > rate in placebo in any dose group but did not meet this criteria in all doses combined: nausea, diarrhea, vomiting, and depression (depressed mood, depression, depressive symptom).
a The abdominal pain term includes abdominal pain, abdominal pain lower, abdominal pain upper, and abdominal tenderness.
b The anxiety term includes anxiety and nervousness.
c The rash term includes rash, rash generalized, and rash papular.
d The abdominal/stomach discomfort term includes abdominal discomfort, epigastric discomfort, and stomach discomfort.

Adjunctive Trial

Table 11: Percentage of Patients Experiencing Most Common ( ≥ 5% and at least twice the rate for placebo) Adverse Reactions in the Short-Term Adjunctive Study 3

Adverse Reaction Term Placebo+ stimulant
(N=153)
INTUNIV® + stimulant
AM
(N=150)
PM
(N=152)
All Doses
(N=302)
Somnolencea 7% 18% 18% 18%
Insomniab 6% 10% 14% 12%
Abdominal Painc 3% 8% 12% 10%
Fatigue 3% 12% 7% 10%
Dizziness 4% 10% 5% 8%
Decreased Appetite 4% 7% 8% 7%
Nausea 3% 3% 7% 5%
a The somnolence term includes somnolence, sedation, and hypersomnia.
b The insomnia term includes insomnia, initial insomnia, middle insomnia, terminal insomnia, and sleep disorder.
c The abdominal pain term includes abdominal pain, abdominal pain lower, abdominal pain upper, and abdominal tenderness.

There were no specific adverse reactions ≥ 2% in any treatment group that led to discontinuation in the short-term adjunctive study (Study 3).

Table 12: Other Common Adverse Reactions ( ≥ 2% for all doses of INTUNIV and > rate in placebo) in the Short-Term Adjunctive Study 3

Adverse Reaction Term Placebo
(N=153)
INTUNIV® + stimulant
AM
(N=150)
PM
(N=152)
All Doses of INTUNIV®
(N=302)
Headache 13% 21% 21% 21%
Diarrhea 1% 4% 3% 4%
Hypotensiona 0% 4% 2% 3%
Constipation 0% 2% 3% 2%
Affect Labilityb 1% 3% 2% 2%
Dry Mouth 0% 1% 3% 2%
Bradycardiac 0% 1% 3% 2%
Postural Dizziness 0% 1% 3% 2%
Rashd 1% 1% 2% 2%
Nightmaree 1% 2% 1% 2%
T achycardiaf 1% 2% 1% 2%
Adverse reactions ≥ 2% for all doses of INTUNIV and > rate in placebo in any dose group but did not meet this criteria in all doses combined: irritability, vomiting, asthma (asthma, bronchospasm, wheezing), and enuresis (enuresis, nocturia, urinary incontinence).
a The hypotension term includes hypotension, diastolic hypotension, orthostatic hypotension, blood pressure decreased, blood pressure diastolic decreased, blood pressure systolic decreased.
b The affect lability term includes affect lability and mood swings.
c The bradycardia term includes bradycardia and sinus bradycardia.
d The rash term includes rash, rash generalized, and rash papular.
e The nightmare term includes abnormal dreams, nightmare, and sleep terror.
f The tachycardia term includes tachycardia and sinus tachycardia.

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 seated systolic blood pressure, diastolic blood pressure, and pulse were -5.4 mmHg, -3.4 mmHg, and -5.5 bpm, respectively, for all doses combined (generally one week after reaching target doses). For the respective fixed doses 1 mg/day, 2 mg/day, 3 mg/day or 4 mg/day the maximum mean changes in seated systolic blood pressure were -4.3 mmHg, -5.5 mmHg, -5.4 mmHg and -8.2 mmHg. For these respective fixed doses the maximum mean changes in seated diastolic blood pressure were -3.4 mmHg, -3.3 mmHg, -4.4 mmHg and -5.4 mmHg. For these respective fixed doses the maximum mean changes in seated pulse were 4.8 bpm, -3.1 bpm, -6.5 bpm and -8.6 bpm. 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. These findings were generally similar in the monotherapy flexible dose trials (Studies 4 and 5). 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 patients in the clinical program. The majority of these cases occurred in the long-term, open-label studies.

Effects on Height, Weight, and Body Mass Index (BMI)

Patients taking INTUNIV® demonstrated similar growth compared to normative data. Patients taking INTUNIV® had a mean increase in weight of 0.5 kg compared to those receiving placebo over a comparable treatment period. Patients receiving INTUNIV® for at least 12 months in open-label studies gained an average of 8 kg in weight and 8 cm (3 in) in height. The height, weight, and BMI percentile remained stable in patients at 12 months in the long-term studies compared to when they began receiving INTUNIV® .

Other Adverse Reactions Observed in Clinical Studies

Table 13 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 13: Other adverse reactions observed in clinical studies

Body System Adverse Reaction
Cardiac Atrioventricular block
General Asthenia, chest pain
Immune System Disorders Hypersensitivity
Investigations Increased alanine amino transferase
Nervous system Convulsion
Renal Increased urinary frequency
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.

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) »

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Intuniv - User Reviews

Intuniv User Reviews

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

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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.


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