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Guanfacine

Intuniv · ATC code C02AC02

Also known as: Guanfacin, Guanfasin, Guanfacina

Key facts
Active substance
Guanfacine
ATC code
C02AC02
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Intuniv 1 mg prolonged-release tablets / Intuniv 2 mg prolonged-release tablets / Intuniv 3 mg prolonged-release tablets
Marketing authorisation holder
Takeda Pharmaceuticals International AG Ireland
Information as of
2026-10-27

Key facts

Guanfacine is a selective alpha-2A adrenergic receptor agonist (non-stimulant). It is used to treat ADHD in children and adolescents when stimulants are not suitable.

What it is used for

  • ADHD in children and adolescents 6-17 years old for whom stimulants are not suitable, not tolerated or ineffective
  • As part of a comprehensive treatment programme

Dosing

  • Starting dose 1 mg once daily; increase by no more than 1 mg per week
  • Maintenance range 0.05-0.12 mg/kg/day depending on response and tolerability
  • Children 6-12 years (25 kg and up): maximum 4 mg; adolescents have weight-based maximum doses (titration tables in the full text)
  • Weekly monitoring of somnolence, sedation, blood pressure and heart rate during titration; at least every 3 months in the first year
  • Dose adjustments with CYP3A4/5 inhibitors or inducers (see full text)

Contraindications

  • Hypersensitivity to the active substance or any excipient

Important warnings

  • Hypotension, bradycardia and syncope (risk of falls or accidents); assess cardiovascular status before starting
  • Blood pressure and heart rate increase upon discontinuation
  • Somnolence and sedation, mainly early in treatment or after dose increases
  • Weight increase; caution with QT prolongation and with medicines that lower blood pressure

Side effects

  • Very common: somnolence (40.6%), headache, fatigue, upper abdominal pain, sedation
  • Common: decreased appetite, depression, anxiety, insomnia, dizziness, lethargy
  • Serious: hypotension, weight increase, bradycardia, syncope

Interactions

  • CYP3A4/5 inhibitors or inducers may raise or lower guanfacine levels
  • Guanfacine may increase levels of CYP3A4/5, MATE1 and OCT1 substrates (e.g. metformin)
  • Antihypertensives and drugs that lower heart rate or increase syncope risk: caution

Pregnancy and breastfeeding

  • Not recommended during pregnancy or in women of childbearing potential not using contraception; a risk to the breast-fed infant cannot be excluded

Summary of the official product information, written with AI on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

Common questions – ask Medelix

For patients

Package leaflet, verbatim

Package leaflet for patients →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • IntunivTakeda Pharmaceuticals International AG Ireland · EMEA/H/C/003759
  • Paxneury · genericNeuraxpharm Pharmaceuticals S.L. · EMEA/H/C/006312

Source: European Medicines Agency (EMA), product information

Germany

  • Guanfacin NeuraxpharmNeuraxpharm Arzneimittel Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Turkey

  • Arislow ERALİ RAİF İLAÇ SAN. A.Ş. · 7 register entries
  • GuagoFARMA-TEK İLAÇ SAN. VE TİC. A.Ş. · 7 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 3 more European countries
Iceland
Intuniv, Paxneury
Liechtenstein
Intuniv, Paxneury
Norway
Intuniv, Paxneury

EMA – Article 57 product data (EU/EEA), 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Other substances in the same group

Another question about this substance?

Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. European Medicines Agency. Intuniv – EPAR, Product Information. 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/intuniv-epar-product-information_en.pdf
  2. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.