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guanfacine

Intuniv · ATC code C02AC02

Also known as: Guanfacin

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 (Claude, Anthropic) 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.

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 (OF THE TEXT Detailed information on this medicinal product i). 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.