Is Guanfacine registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 4 valid registrations of Guanfacine, including Intuniv XR (1 mg, Prolonged-release tablet, SAR 282.25); Intuniv XR (2 mg, Prolonged-release tablet, SAR 294.50); Intuniv XR (3 mg, Prolonged-release tablet, SAR 329.85); Intuniv XR (4 mg, Prolonged-release tablet, SAR 383.40).

Is Guanfacine approved by the US FDA?

Drugs@FDA lists 27 application product lines for Guanfacine, including GUANFACINE HYDROCHLORIDE (Prescription); GUANFACINE HYDROCHLORIDE (Prescription); GUANFACINE HYDROCHLORIDE (Prescription); GUANFACINE HYDROCHLORIDE (Prescription); INTUNIV (Prescription).

Is Guanfacine authorised in the European Union?

EMA lists 2 centrally authorised medicines containing Guanfacine: Intuniv, Paxneury.

Are there safety signals or safety updates for Guanfacine?

US FDA: 1 entry (latest 2019-12-27).

Active substance

Guanfacine

SFDA 4
US FDA 27
EMA 2
Health Canada 24
US price lines 10
NHS prices 4
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Intuniv XR	1 mg	Prolonged-release tablet · Oral use	28 Blister	SAR 282.25	NCE · Prescription	Takeda Pharmaceuticals International AG	Valid
Intuniv XR	2 mg	Prolonged-release tablet · Oral use	28 Blister	SAR 294.50	NCE · Prescription	Takeda Pharmaceuticals International AG	Valid
Intuniv XR	3 mg	Prolonged-release tablet · Oral use	28 Blister	SAR 329.85	NCE · Prescription	Takeda Pharmaceuticals International AG	Valid
Intuniv XR	4 mg	Prolonged-release tablet · Oral use	28 Blister	SAR 383.40	NCE · Prescription	Takeda Pharmaceuticals International AG	Valid

Indications — CHI Daman Drug Formulary

AUTISM SPECTRUM DISORDER; TOURETTE SYNDROME

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
GUANFACINE HYDROCHLORIDE	EQ 1MG BASE; EQ 2MG BASE	tablet · oral	WATSON LABS	Prescription	17 Oct 1995
GUANFACINE HYDROCHLORIDE	EQ 1MG BASE; EQ 2MG BASE	tablet · oral	AUROBINDO PHARMA USA	Prescription	27 Jan 1997
GUANFACINE HYDROCHLORIDE	EQ 1MG BASE; EQ 2MG BASE	tablet · oral	EPIC PHARMA LLC	Prescription	28 Feb 1997
GUANFACINE HYDROCHLORIDE	EQ 1MG BASE; EQ 2MG BASE	tablet · oral	AMNEAL PHARM	Prescription	25 Nov 1998
INTUNIV	EQ 1MG BASE; EQ 2MG BASE; EQ 3MG BASE; EQ 4MG BASE	tablet, extended release · oral	TAKEDA PHARMS USA	Prescription	2 Sep 2009
GUANFACINE HYDROCHLORIDE	EQ 1MG BASE; EQ 2MG BASE; EQ 3MG BASE; EQ 4MG BASE	tablet, extended release · oral	ACTAVIS ELIZABETH	Prescription	5 Oct 2012
GUANFACINE HYDROCHLORIDE	EQ 1MG BASE; EQ 2MG BASE; EQ 3MG BASE; EQ 4MG BASE	tablet, extended release · oral	TEVA PHARMS USA	Prescription	2 Jun 2015
GUANFACINE HYDROCHLORIDE	EQ 1MG BASE; EQ 2MG BASE; EQ 3MG BASE; EQ 4MG BASE	tablet, extended release · oral	TWI PHARMS	Prescription	2 Jun 2015
GUANFACINE HYDROCHLORIDE	EQ 1MG BASE; EQ 2MG BASE; EQ 3MG BASE; EQ 4MG BASE	tablet, extended release · oral	SANDOZ	Prescription	3 Jun 2015
GUANFACINE HYDROCHLORIDE	EQ 1MG BASE; EQ 2MG BASE; EQ 3MG BASE; EQ 4MG BASE	tablet, extended release · oral	APOTEX	Prescription	25 Jul 2018
GUANFACINE HYDROCHLORIDE	EQ 1MG BASE; EQ 2MG BASE; EQ 3MG BASE; EQ 4MG BASE	tablet, extended release · oral	YICHANG HUMANWELL	Prescription	25 Nov 2020
GUANFACINE HYDROCHLORIDE	EQ 1MG BASE; EQ 2MG BASE	tablet · oral	UNICHEM	Prescription	3 Mar 2021
GUANFACINE HYDROCHLORIDE	EQ 1MG BASE; EQ 2MG BASE	tablet · oral	AIPING PHARM INC	Prescription	8 Jun 2022
GUANFACINE HYDROCHLORIDE	EQ 1MG BASE; EQ 2MG BASE	tablet · oral	AJANTA PHARMA LTD	Prescription	27 Apr 2023
GUANFACINE HYDROCHLORIDE	EQ 1MG BASE; EQ 2MG BASE; EQ 3MG BASE; EQ 4MG BASE	tablet, extended release · oral	ALEMBIC	Prescription	7 Aug 2023
GUANFACINE HYDROCHLORIDE	EQ 1MG BASE; EQ 2MG BASE	tablet · oral	PHARMAZONE	Prescription	5 Oct 2023
GUANFACINE HYDROCHLORIDE	EQ 1MG BASE; EQ 2MG BASE	tablet · oral	RUBICON RESEARCH	Prescription	17 Oct 2023
GUANFACINE HYDROCHLORIDE	EQ 1MG BASE; EQ 2MG BASE	tablet · oral	XIROMED	Prescription	23 Feb 2024
GUANFACINE HYDROCHLORIDE	EQ 1MG BASE; EQ 2MG BASE; EQ 3MG BASE; EQ 4MG BASE	tablet, extended release · oral	FOSUN WANBANG	Prescription	12 Jun 2024
GUANFACINE HYDROCHLORIDE	EQ 1MG BASE; EQ 2MG BASE; EQ 3MG BASE; EQ 4MG BASE	tablet, extended release · oral	UNICHEM	Prescription	19 Nov 2024
GUANFACINE HYDROCHLORIDE	EQ 1MG BASE; EQ 2MG BASE; EQ 3MG BASE; EQ 4MG BASE	tablet, extended release · oral	RUBICON RESEARCH	Prescription	15 Apr 2025
GUANFACINE HYDROCHLORIDE	EQ 1MG BASE; EQ 2MG BASE	tablet · oral	ASCENT PHARMS INC	Prescription	24 Mar 2026
TENEX	EQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; EQ 3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet · oral	PROMIUS PHARMA	Discontinued	27 Oct 1986
GUANFACINE HYDROCHLORIDE	EQ 1MG BASE; EQ 2MG BASE	tablet · oral	WATSON LABS	Discontinued	25 Jun 1997
GUANFACINE HYDROCHLORIDE	EQ 1MG BASE; EQ 2MG BASE; EQ 3MG BASE; EQ 4MG BASE	tablet, extended release · oral	PHARMOBEDIENT	Discontinued	2 Jun 2015

2 more — full table

EMA European Union — centrally authorised medicines

Intuniv Takeda Pharmaceuticals International AG Ireland · Authorised · authorised 17 Sep 2015 · ATC C02AC02

Therapeutic indication (EMA)

Intuniv is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents 6 17 years old for whom stimulants are not suitable, not tolerated or have been shown to be ineffective. Intuniv must be used as a part of a comprehensive ADHD treatment programme, typically including psychological, educational and social measures.

Paxneury Neuraxpharm Pharmaceuticals S.L. · Authorised · authorised 26 Feb 2025 · ATC C02AC02

Therapeutic indication (EMA)

Paxneury is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents 6‑17 years old for whom stimulants are not suitable, not tolerated or have been shown to be ineffective. Paxneury must be used as a part of a comprehensive ADHD treatment programme, typically including psychological, educational and social measures.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
AG-GUANFACINE XR	02525127	1 MG	TABLET (EXTENDED-RELEASE) · ORAL	ANGITA PHARMA INC.
AG-GUANFACINE XR	02525135	2 MG	TABLET (EXTENDED-RELEASE) · ORAL	ANGITA PHARMA INC.
AG-GUANFACINE XR	02525143	3 MG	TABLET (EXTENDED-RELEASE) · ORAL	ANGITA PHARMA INC.
AG-GUANFACINE XR	02525151	4 MG	TABLET (EXTENDED-RELEASE) · ORAL	ANGITA PHARMA INC.
APO-GUANFACINE XR	02523728	1 MG	TABLET (EXTENDED-RELEASE) · ORAL	APOTEX INC
APO-GUANFACINE XR	02523736	2 MG	TABLET (EXTENDED-RELEASE) · ORAL	APOTEX INC
APO-GUANFACINE XR	02523744	3 MG	TABLET (EXTENDED-RELEASE) · ORAL	APOTEX INC
APO-GUANFACINE XR	02523752	4 MG	TABLET (EXTENDED-RELEASE) · ORAL	APOTEX INC
INTUNIV XR	02409100	1 MG	TABLET (EXTENDED-RELEASE) · ORAL	TAKEDA CANADA INC
INTUNIV XR	02409119	2 MG	TABLET (EXTENDED-RELEASE) · ORAL	TAKEDA CANADA INC
INTUNIV XR	02409127	3 MG	TABLET (EXTENDED-RELEASE) · ORAL	TAKEDA CANADA INC
INTUNIV XR	02409135	4 MG	TABLET (EXTENDED-RELEASE) · ORAL	TAKEDA CANADA INC
JAMP GUANFACINE XR	02523558	1 MG	TABLET (EXTENDED-RELEASE) · ORAL	JAMP PHARMA CORPORATION
JAMP GUANFACINE XR	02523566	2 MG	TABLET (EXTENDED-RELEASE) · ORAL	JAMP PHARMA CORPORATION
JAMP GUANFACINE XR	02523574	3 MG	TABLET (EXTENDED-RELEASE) · ORAL	JAMP PHARMA CORPORATION
JAMP GUANFACINE XR	02523582	4 MG	TABLET (EXTENDED-RELEASE) · ORAL	JAMP PHARMA CORPORATION
PRO-GUANFACINE XR	02525224	1 MG	TABLET (EXTENDED-RELEASE) · ORAL	PRO DOC LIMITEE
PRO-GUANFACINE XR	02525232	2 MG	TABLET (EXTENDED-RELEASE) · ORAL	PRO DOC LIMITEE
PRO-GUANFACINE XR	02525240	3 MG	TABLET (EXTENDED-RELEASE) · ORAL	PRO DOC LIMITEE
PRO-GUANFACINE XR	02525259	4 MG	TABLET (EXTENDED-RELEASE) · ORAL	PRO DOC LIMITEE
SANDOZ GUANFACINE XR	02563185	1 MG	TABLET (EXTENDED-RELEASE) · ORAL	SANDOZ CANADA INCORPORATED
SANDOZ GUANFACINE XR	02563193	2 MG	TABLET (EXTENDED-RELEASE) · ORAL	SANDOZ CANADA INCORPORATED
SANDOZ GUANFACINE XR	02563207	3 MG	TABLET (EXTENDED-RELEASE) · ORAL	SANDOZ CANADA INCORPORATED
SANDOZ GUANFACINE XR	02563215	4 MG	TABLET (EXTENDED-RELEASE) · ORAL	SANDOZ CANADA INCORPORATED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	GUANFACINE 1 MG TABLET	$0.14657	per EA	23 Sep 2026
US NADAC	GUANFACINE 2 MG TABLET	$0.26727	per EA	23 Sep 2026
US NADAC	GUANFACINE HCL ER 1 MG TABLET	$0.13256	per EA	23 Sep 2026
US NADAC	GUANFACINE HCL ER 2 MG TABLET	$0.14767	per EA	23 Sep 2026
US NADAC	GUANFACINE HCL ER 3 MG TABLET	$0.16584	per EA	23 Sep 2026
US NADAC	GUANFACINE HCL ER 4 MG TABLET	$0.17621	per EA	23 Sep 2026
US NADAC	INTUNIV ER 1 MG TABLET	$9.38648	per EA	23 Sep 2026
US NADAC	INTUNIV ER 2 MG TABLET	$9.26199	per EA	23 Sep 2026
US NADAC	INTUNIV ER 3 MG TABLET	$9.29231	per EA	23 Sep 2026
US NADAC	INTUNIV ER 4 MG TABLET	$9.26984	per EA	23 Sep 2026
NHS Drug Tariff	Guanfacine 1mg modified-release tablets	£56.00	28 tablet	1 Oct 2026
NHS Drug Tariff	Guanfacine 2mg modified-release tablets	£58.52	28 tablet	1 Oct 2026
NHS Drug Tariff	Guanfacine 3mg modified-release tablets	£65.52	28 tablet	1 Oct 2026
NHS Drug Tariff	Guanfacine 4mg modified-release tablets	£76.16	28 tablet	1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

US FDA 27 Dec 2019 INTUNIV — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for guanfacine →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.