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Intuniv

  • Generic Name: guanfacine
  • Brand Name: Intuniv
Last reviewed on RxList: 12/7/2017

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Intuniv(guanfacine) side effects drug center

Intuniv Side Effects Center

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Medical Editor: John P. Cunha, DO, FACOEP


Last reviewed on RxList
12/07/2017

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. 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. 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 breastfeeding.

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.

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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)

Learn More »

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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 TermPlacebo

(N=149)
INTUNIV® (mg)
Img*
(N=61)
2mg
(N=150)
3mg
(N=151)
4mg
(N=151)
All Doses of INTUNIV®
(N=513)
Somnolencea11%28%30%38%51%38%
Fatigue3%10%13%17%15%14%
Hypotensionb3%8%5%7%8%7%
Dizziness4%5%3%7%10%6%
Lethargy 3%2%3%8%7%6%
Nausea2%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 than in placebo) in Fixed Dose
Studies 1 and 2

Adverse Reaction TermPlacebo
(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 patients4 (3%)2 (3%)10 (7%)15 (10%)27 (18%)54 (11%)
Somnolencea1 (1%)2 (3%)5 (3%)6 (4%)17 (11%)30 (6%)
Fatigue0 (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 than in placebo) in Fixed Dose Studies 1 and 2

Adverse Reaction TermPlacebo

(N=149)
INTUNIV® (mg)
1mg*
(N=61)
2mg
(N=150)
3mg
(N=151)
4mg
(N=151)
All Doses of INTUNIV®

(N=513)
Headache19%26%25%16%28%23%
Abdominal Paina9%10%7%11%15%11%
Decreased Appetite4%5%4%9%6%6%
Irritability4%5%8%3%7%6%
Constipation1%2%2%3%4%3%
Nightmareb0%0%0%3%4%2%
Enuresis c1%0%1%3%2%2%
Affect Lability d1%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 TermPlacebo

(N=112)
INTUNIV®
AM
(N=107)
PM
(N=114)
All Doses of INTUNIV®
(N=221)
Somnolencea15%57%54%56%
Abdominal Painb7%8%19%14%
Fatigue3%10%11%11%
Irritability3%7%7%7%
Nausea1%6%5%5%
Dizziness3%6%4%5%
Vomiting2%7%4%5%
Hypotensionc0%6%4%5%
Decreased Appetite3%6%3%4%
Enuresisd1%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.

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 TermPlacebo

(N=112) n (%)
INTUNIV®
AM
(N=107) n (%)
PM
(N=114) n (%)
All Doses of INTUNIV®
(N=221) n (%)
Total patients0 (0%)8 (7%)7 (6%)15 (7%)
Somnolencea0 (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 TermPlacebo
(N=112)
INTUNIV®
AM
(N=107)
PM
(N=114)
All Doses of INTUNIV®
(N=221)
Headache11%18%16%17%
Insomniaa6%8%6%7%
Diarrhea4%4%6%5%
Lethargy0%4%3%3%
Constipation2%2%4%3%
Dry Mouth1%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 for placebo) Adverse Reactions in the
Monotherapy Flexible Dose Study 5

Adverse Reaction TermPlacebo
(N=155)
All Doses of INTUNIV®
(N=157)
Somnolencea23%54%
Insomniab6%13%
Hypotensionc3%9%
Dry Mouth0%8%
Postural Dizziness2%5%
Bradycardiad0%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 TermPlacebo
(N=155)
INTUNIV® All Doses of INTUNIV®

(N=157)
Headache18%27%
Fatigue12%22%
Dizziness10%16%
Decreased Appetite14%15%
Abdominal Paina8%12%
Irritability4%7%
Anxietyb3%5%
Rashc1%3%
Constipation0%3%
Increased Weight2%3%
Abdominal/Stomach Discomfortd1%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 TermPlacebo+ stimulant
(N=153)
INTUNIV® + stimulant
AM
(N=150)
PM
(N=152)
All Doses

(N=302)
Somnolencea7%18%18%18%
Insomniab6%10%14%12%
Abdominal Painc3%8%12%10%
Fatigue3%12%7%10%
Dizziness4%10%5%8%
Decreased Appetite4%7%8%7%
Nausea3%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 than in placebo) in the Short-Term
Adjunctive Study 3

Adverse Reaction TermPlacebo
(N=153)
INTUNIV® + stimulant
AM
(N=150)
PM
(N=152)
All Doses of INTUNIV®
(N=302)
Headache13%21%21%21%
Diarrhea1%4%3%4%
Hypotensiona0%4%2%3%
Constipation0%2%3%2%
Affect Labilityb1%3%2%2%
Dry Mouth0%1%3%2%
Bradycardiac0%1%3%2%
Postural Dizziness0%1%3%2%
Rashd1%1%2%2%
Nightmaree1%2%1%2%
Tachycardiaf1%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.

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 SystemAdverse Reaction
CardiacAtrioventricular block
General Asthenia , chest pain
Immune System DisordersHypersensitivity
InvestigationsIncreased alanine amino transferase
Nervous system Convulsion
RenalIncreased 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)

Read More »

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© 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.

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Intuniv Drug Imprint

000935960_PB

oval, white, imprinted with TEVA, 5960

000935961_PB

oval, white, imprinted with TEVA, 5961

000935963_PB

oval, white, imprinted with TEVA, 5963

000935964_PB

oval, white, imprinted with TEVA, 5964

002282850_PB

round, orange, imprinted with LOGO, 850

002282851_PB

oval, orange, imprinted with LOGO, 851

002282853_PB

round, yellow, imprinted with LOGO, 853

002282855_PB

oval, yellow, imprinted with LOGO, 855

003781160_PB

round, white, imprinted with M, G4

003781190_PB

round, blue, imprinted with M, G5

005910444_PB

round, pink, imprinted with WATSON 444

005910453_PB

round, red, imprinted with WATSON 453

422910310_PB

oval, white, imprinted with AN, 711

422910311_PB

oval, white, imprinted with AN, 713

540920513_PB

round, white, imprinted with 503 1mg

540920515_PB

capsule, white, imprinted with 503, 2MG

540920517_PB

round, green, imprinted with 503, 3MG

540920519_PB

oblong, green, imprinted with 503, 4MG

651620711_PB

oval, white, imprinted with AN, 711

651620713_PB

oval, white, imprinted with AN, 713

Guanfacine 1 mg-AMN

oval, white, imprinted with AN, 711

Guanfacine 1 mg-WAT

round, pink, imprinted with WATSON 444

Guanfacine 2 mg-AMN

oval, white, imprinted with AN, 713

Guanfacine 2 mg-MYL

round, blue, imprinted with M, G5

Tenex 2 mg

diamond, yellow, imprinted with TENEX, 2 AHR

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