Guanfacine is a central alpha-2 adrenergic agonist indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications. It is available as extended-release tablets and tablets for oral use. MedsAcross supplies Guanfacine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
INTUNIV ® is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications. INTUNIV is a central alpha 2A -adrenergic receptor agonist indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications.
Source: US FDA prescribing information
Guanfacine is a central alpha 2A -adrenergic receptor agonist. Guanfacine is not a central nervous system (CNS) stimulant. The mechanism of action of guanfacine in ADHD is not known.
Source: US FDA prescribing information
Recommended dose: 1 mg to 7 mg (0.05 to 0.12 mg/kg target weight based dose range) once daily in the morning or evening based on clinical response and tolerability. Begin at a dose of 1 mg once daily and adjust in increments of no more than 1 mg/week. Do not crush, chew or break tablets before swallowing. Do not administer with high-fat meals, because of increased exposure. Do not substitute for immediate-release guanfacine tablets on a mg-per-mg basis, because of differing pharmacokinetic profiles. If switching from immediate-release guanfacine, discontinue that treatment and titrate with INTUNIV as directed. When discontinuing, taper the dose in decrements of no more than 1 mg every 3 to 7 days to avoid rebound hypertension.
Source: US FDA prescribing information
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. History of hypersensitivity to INTUNIV, its inactive ingredients, or other products containing guanfacine.
Source: US FDA prescribing information
Hypotension, bradycardia, syncope: Titrate slowly and monitor vital signs frequently in patients at risk for hypotension, heart block, bradycardia, syncope, cardiovascular disease, vascular disease, cerebrovascular disease or chronic renal failure. Measure heart rate and blood pressure prior to initiation of therapy, following dose increases, and periodically while on therapy. Avoid concomitant use of drugs with additive effects unless clinically indicated. Advise patients to avoid becoming dehydrated or overheated. Sedation and somnolence: Occur commonly with INTUNIV. Consider the potential for additive sedative effects with CNS depressant drugs. Caution patients against operating heavy equipment or driving until they know how they respond to INTUNIV.
Source: US FDA prescribing information
The following serious adverse reactions are described elsewhere in the labeling: Hypotension, bradycardia, and syncope Sedation and somnolence Cardiac conduction abnormalities Rebound Hypertension Most common adverse reactions (≥5% and at least twice placebo rate) in fixed-dose monotherapy ADHD trials in children and adolescents (6 to 17 years): hypotension, somnolence, fatigue, nausea, and lethargy. Flexible dose-optimization ADHD trials in children (6 to 12 years) and adolescents (13 to 17 years): somnolence, hypotension, abdominal pain, insomnia, fatigue, dizziness, dry mouth, irritability, nausea, vomiting, and bradycardia. Adjunctive treatment to psychostimulant ADHD trial in children and adolescents (6 to 17 years): somnolence, fatigue, insomnia, dizziness, and abdominal pain.
Source: US FDA prescribing information
Table 14 contains clinically important drug interactions with INTUNIV. Table 14: Clinically Important Drug Interactions: Effect of other Drugs on INTUNIV Concomitant Drug Name or Drug Class Clinical Rationale and Magnitude of Drug Interaction Clinical Recommendation Strong and moderate CYP3A4 inhibitors, e.g., ketoconazole, fluconazole Guanfacine is primarily metabolized by CYP3A4 and its plasma concentrations can be significantly affected resulting in an increase in exposure Consider dose reduction Strong and moderate CYP3A4 inducers, e.g., rifampin, efavirenz Guanfacine is primarily metabolized by CYP3A4 and its plasma concentrations can be significantly affected resulting in a decrease in exposure Consider dose increase Strong and moderate CYP3A4 inhibitors increase guanfacine exposure.
Source: US FDA prescribing information
Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
10 presentations of Guanfacine, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Guanfacine 1 mg tabletOralGeneric name | — | US FDA | Available on request |
| Guanfacine 1 mg extended-release tabletOralGeneric name | — | US FDA | Available on request |
| Guanfacine 2 mg extended-release tabletOralGeneric name | — | US FDA | Available on request |
| Guanfacine 2 mg tabletOralGeneric name | — | US FDA | Available on request |
| Guanfacine 3 mg extended-release tabletOralGeneric name | — | US FDA | Available on request |
| Guanfacine 4 mg extended-release tabletOralGeneric name | — | US FDA | Available on request |
| Intuniv 1 mg extended-release tabletOral | Takeda Pharmaceuticals | US FDA | Available on request |
| Intuniv 2 mg extended-release tabletOral | Takeda Pharmaceuticals | US FDA | Available on request |
| Intuniv 3 mg extended-release tabletOral | Takeda Pharmaceuticals | US FDA | Available on request |
| Intuniv 4 mg extended-release tabletOral | Takeda Pharmaceuticals | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Conditions linked to Guanfacine in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 10 presentations of Guanfacine and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Guanfacine, including Intuniv.
Yes. The US FDA first approved Guanfacine on 27 October 1986, according to Drugs@FDA.
Yes. Guanfacine has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Guanfacine is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Guanfacine is classified under ATC code C02AC02 (Guanfacine).
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