Brand Name
Intuniv
Generic Name
Guanfacine
View Brand Information FDA approval date: October 17, 1995
Classification: Central alpha-2 Adrenergic Agonist
Form: Tablet
What is Intuniv (Guanfacine)?
Guanfacine hydrochloride tablets are indicated in the management of hypertension. Guanfacine may be given alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.
Approved To Treat
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Brand Information
Intuniv (guanfacine)
1INDICATIONS AND USAGE
INTUNIV
2DOSAGE FORMS AND STRENGTHS
1 mg, 2 mg, 3 mg, and 4 mg extended-release tablets
3CONTRAINDICATIONS
INTUNIV is contraindicated in patients with a history of a hypersensitivity reaction to INTUNIV or its inactive ingredients, or other products containing guanfacine. Rash and pruritus have been reported.
4ADVERSE REACTIONS
The following serious adverse reactions are described elsewhere in the labeling:
- Hypotension, bradycardia, and syncope
- Sedation and somnolence
- Cardiac conduction abnormalities
- Rebound Hypertension [see
4.1Clinical 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.
4.2Postmarketing 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: erectile dysfunction
Respiratory System: dyspnea
Skin and Appendages: alopecia, dermatitis, exfoliative dermatitis, pruritus, rash
Special Senses: alterations in taste
5DRUG INTERACTIONS
Table 14 contains clinically important drug interactions with INTUNIV
6DESCRIPTION
INTUNIV is a once-daily, extended-release formulation of guanfacine hydrochloride (HCl) in a matrix tablet formulation for oral administration only. The chemical designation is N-amidino-2-(2,6-dichlorophenyl) acetamide monohydrochloride. The molecular formula is C
Guanfacine HCl is a white to off-white crystalline powder, sparingly soluble in water (approximately 1 mg/mL) and alcohol and slightly soluble in acetone. The only organic solvent in which it has relatively high solubility is methanol (>30 mg/mL). Each tablet contains guanfacine HCl equivalent to 1 mg, 2 mg, 3 mg, or 4 mg of guanfacine base. The tablets also contain hypromellose, methacrylic acid copolymer, lactose, povidone, crospovidone, microcrystalline cellulose, fumaric acid, and glyceryl behenate. In addition, the 3-mg and 4-mg tablets also contain green pigment blend PB-1763.
7CLINICAL STUDIES
Efficacy of INTUNIV in the treatment of ADHD was established in children and adolescents (6 to 17 years) in:
- Five short-term, placebo-controlled monotherapy trials (Studies 1, 2, 4, 5, and 6).
- One short-term, placebo-controlled adjunctive trial with psychostimulants (Study 3).
- One long-term, placebo-controlled monotherapy maintenance trial (Study 7).
8HOW SUPPLIED/STORAGE AND HANDLING
INTUNIV is supplied in 1 mg, 2 mg, 3 mg, and 4 mg strength extended-release tablets in 100 count bottles.
9PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (
10Patient Information
INTUNIV
Read the Patient Information that comes with INTUNIV before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your medical condition or your treatment.
What is INTUNIV?
INTUNIV is a prescription medicine used to treat the symptoms of attention deficit hyperactivity disorder (ADHD). INTUNIV may be used alone or with ADHD stimulant medicines.
INTUNIV is not a central nervous system (CNS) stimulant.
It is not known if INTUNIV is safe and effective in children younger than 6 years of age.
Who should not take INTUNIV?
Do not take INTUNIV if you are allergic to guanfacine or any of the ingredients in INTUNIV. See the end of this leaflet for a complete list of ingredients in INTUNIV.
What should I tell my doctor before taking INTUNIV?
Before you take INTUNIV, tell your doctor if you:
- have heart problems or a low heart rate
- have fainted
- have low or high blood pressure
- have liver or kidney problems
- have any other medical conditions
- are pregnant or plan to become pregnant. It is not known if INTUNIV will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
- are breastfeeding or plan to breastfeed. It is not known if INTUNIV passes into your breast milk. Talk to your doctor about the best way to feed your baby while taking INTUNIV.
Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
INTUNIV may affect the way other medicines work, and other medicines may affect how INTUNIV works.
Especially tell your doctor if you take:
- ketoconazole
- medicines that can affect enzyme metabolism
- high blood pressure medicine
- sedatives
- benzodiazepines
- barbiturates
- antipsychotics
Ask your doctor or pharmacist for a list of these medicines, if you are not sure.
Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine.
How should I take INTUNIV?
- Take INTUNIV exactly as your doctor tells you.
- Your doctor may change your dose. Do not change your dose of INTUNIV without talking to your doctor.
- Do not stop taking INTUNIV without talking to your doctor.
- Try not to miss your dose of INTUNIV. If you miss a dose of INTUNIV, take the next dose at your regular time. If you miss 2 or more doses, talk to your doctor, as you may need to restart INTUNIV with a lower dose.
- Do not take a double dose to make up for a missed dose.
- INTUNIV should be taken 1 time a day in the morning or in the evening, either alone or in combination with an ADHD stimulant medicine that your doctor may prescribe. Your doctor will tell you when to take INTUNIV and when to take your ADHD stimulant medication.
- INTUNIV should be swallowed whole with a small amount of water, milk, or other liquid.
- Do not crush, chew, or break INTUNIV. Tell your doctor if you cannot swallow INTUNIV whole.
- Do not take INTUNIV with a high-fat meal.
- Your doctor will check your blood pressure and heart rate while you take INTUNIV.
- If you take too much INTUNIV, call your local Poison Control Center at 1-800-222-1222 or go to the nearest emergency room right away.
What should I avoid while taking INTUNIV?
- Do not drive, operate heavy machinery, or do other dangerous activities until you know how INTUNIV affects you. INTUNIV can slow your thinking and motor skills.
- Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking INTUNIV until you talk with your doctor. INTUNIV taken with alcohol or medicines that cause sleepiness or dizziness may make your sleepiness or dizziness worse.
- Do not become dehydrated or overheated. This may increase your chance of having low blood pressure or fainting while taking INTUNIV.
- Do not suddenly stop INTUNIV. Tell your healthcare provider if you have been vomiting and cannot take INTUNIV, you may be at risk for rebound hypertension.
What are the possible side effects of INTUNIV?
INTUNIV may cause serious side effects including:
- low blood pressure
- low heart rate
- fainting
- sleepiness
- increased blood pressure and heart rate after suddenly stopping INTUNIV (rebound hypertension). Suddenly stopping INTUNIV can cause increased blood pressure and heart rate and other withdrawal symptoms such as headache, confusion, nervousness, agitation, and tremors. If these symptoms continue to get worse and are left untreated, it could lead to a very serious condition including very high blood pressure, feeling very sleepy or tired, severe headache, vomiting, vision problems, seizures.
Get medical help right away, if you have any of the symptoms listed above.
The most common side effects of INTUNIV include:
- sleepiness
- tiredness
- trouble sleeping
- low blood pressure
- nausea
- stomach pain
- dizziness
- dry mouth
- irritability
- vomiting
- slow heart rate
Tell the doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of INTUNIV. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store INTUNIV?
- Store INTUNIV between 68°F to 77°F (20°C to 25°C)
Keep INTUNIV and all medicines out of the reach of children.
General Information about the safe and effective use INTUNIV
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use INTUNIV for a condition for which it was not prescribed. Do not give INTUNIV to other people, even if they have the same symptoms that you have. It may harm them.
This leaflet summarizes the most important information about INTUNIV. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about INTUNIV that is written for health professionals.
For more information, go to
What are the ingredients in INTUNIV?
Active ingredient: guanfacine hydrochloride
Inactive ingredients: hypromellose, methacrylic acid copolymer, lactose, povidone, crospovidone, microcrystalline cellulose, fumaric acid, and glycerol behenate. In addition, the 3 mg and 4 mg tablets also contain green pigment blend PB-1763.
This Patient Information has been approved by the U.S. Food and Drug Administration.
Distributed by:
INTUNIV is a registered trademark of Takeda Pharmaceuticals U.S.A., Inc.
© 2025 Takeda Pharmaceuticals U.S.A., Inc. All rights reserved.
Patented: see www.takeda.com/en-us/patents.
Revised: 6/2025
11PRINCIPAL DISPLAY PANEL - 1 mg Tablet Bottle Label
NDC 54092-513-02
intuniv
(guanfacine)
Extended-Release Tablets
(guanfacine)
Extended-Release Tablets
100 Tablets
Each tablet contains: 1 mg of guanfacine, as guanfacine HCl
Tablets should not be crushed,
Distributed by:
Takeda
Product of Spain
12PRINCIPAL DISPLAY PANEL - 2 mg Tablet Bottle Label
NDC 54092-515-02
intuniv
(guanfacine)
Extended-Release Tablets
(guanfacine)
Extended-Release Tablets
100 Tablets
Each tablet contains: 2 mg of guanfacine, as guanfacine HCl
Tablets should not be crushed,
Distributed by:
Takeda
Product of Spain
13PRINCIPAL DISPLAY PANEL - 3 mg Tablet Bottle Label
NDC 54092-517-02
intuniv
(guanfacine)
Extended-Release Tablets
(guanfacine)
Extended-Release Tablets
100 Tablets
Each tablet contains: 3 mg of guanfacine, as guanfacine HCl
Tablets should not be crushed,
Distributed by:
Takeda
Product of Spain
14PRINCIPAL DISPLAY PANEL - 4 mg Tablet Bottle Label
NDC 54092-519-02
intuniv
(guanfacine)
Extended-Release Tablets
(guanfacine)
Extended-Release Tablets
100 Tablets
Each tablet contains: 4 mg of guanfacine, as guanfacine HCl
Tablets should not be crushed,
Distributed by:
Takeda
Product of Spain
15PRINCIPAL DISPLAY PANEL - NDC 54092-520-01
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