Intuniv
- Generic Name: guanfacine
- Brand Name: Intuniv
Intuniv (guanfacine) side effects drug center
Intuniv Side Effects Center
What Is Intuniv?
Intuniv (guanfacine) is an alpha-2 adrenergic agonist 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, Intuniv is not a stimulant. Intuniv is also used to treat high blood pressure (hypertension) and is often given together with other blood pressure medications.
What Are Side Effects of Intuniv?
Common side effects of Intuniv include:
- drowsiness,
- dizziness,
- dry mouth,
- constipation,
- tiredness,
- nausea,
- headache,
- stomach pain,
- weight gain, or
- irritability.
Tell your doctor if you have serious side effects of Intuniv including:
- severe dizziness,
- slow heartbeat,
- fainting, or
- mental/mood changes (such as depression, hallucinations, or thoughts of suicide).
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.
Dosage for Intuniv
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.
What Drugs, Substances, or Supplements Interact with Intuniv?
Intuniv During Pregnancy and Breastfeeding
During pregnancy, Intuniv should be used only when prescribed. It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.
Additional Information
Our Intuniv (guanfacine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Intuniv Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- anxiety, nervousness;
- hallucinations (especially in children);
- severe drowsiness;
- slow heartbeats; or
- a light-headed feeling, like you might pass out;
If you stop taking guanfacine, tell your doctor if you have headaches, confusion, rapid heartbeats, tremors, increased blood pressure, or if you feel nervous or agitated. If left untreated, these symptoms could lead to very high blood pressure, vision problems, or seizures.
Common side effects may include:
- dizziness, drowsiness;
- low blood pressure, slow heartbeats;
- feeling tired or irritable;
- trouble sleeping;
- dry mouth; or
- stomach pain, nausea, constipation.
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)
Intuniv Professional Information
SIDE EFFECTS
The following serious adverse reactions are described elsewhere in the labeling:
- Hypotension, bradycardia, and syncope [see WARNINGS AND PRECAUTIONS]
- Sedation and somnolence [see WARNINGS AND PRECAUTIONS]
- Cardiac conduction abnormalities [see WARNINGS AND PRECAUTIONS]
- Rebound Hypertension [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 practice.
The data described below reflect clinical trial exposure to INTUNIV® in 2,825 patients. This includes 2,330 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) | ||||
| Img* (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). |
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Table 4: Adverse Reactions Leading to Discontinuation
(≥2% for all doses of INTUNIV and >rate than in placebo) in Fixed Dose
Studies 1 and 2
| Adverse Reaction Term | Placebo (N=149) n (%) |
INTUNIV® (mg) | ||||
| Img* (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. |
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Table 5: Other Common Adverse Reactions (≥2% for
all doses of INTUNIV and >rate than 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. |
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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). dThe enuresis term includes enuresis, nocturia, and urinary incontinence. |
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Table 7: Adverse Reactions Leading to Discontinuation
(≥2% for all doses of INTUNIV and >rate than 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 than 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. |
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Table 9: Percentage of Patients Experiencing Most Common
(≥ 5% and at least twice the rate for placebo) 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 than 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. |
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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 than 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% |
| Tachycardiaf | 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. |
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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.
Discontinuation Of Treatment
Blood pressure and pulse may increase above baseline values following discontinuation of INTUNIV®. In five studies of children and adolescents [see Clinical Studies], increases in mean systolic and diastolic blood pressure averaging approximately 3 mmHg and increases in heart rate averaging 5 beats per minute above original baseline were observed upon discontinuation with tapering of INTUNIV+. In a maintenance of efficacy study, increases in blood pressure and heart rate above baseline slowly diminished over the follow up period, which ranged between 3 and 26 weeks post final dose; the estimated average time to return to baseline was between six and twelve months. In this study, the increases in blood pressure and pulse were not considered serious or associated with adverse events. However, individuals may have larger increases than reflected by the mean changes.
In postmarketing experience, following abrupt discontinuation of INTUNIV®, rebound hypertension and hypertensive encephalopathy have been reported [see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS].
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 |
Postmarketing 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, rebound hypertension, hypertensive encephalopathy
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)
&Copy; Intuniv Patient Information is supplied by Cerner Multum, Inc. and Intuniv Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.