Is Methylphenidate registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 9 valid registrations of Methylphenidate, including CONCERTA EXTENDED RELEASE 18MG TABLET (18 mg, Extended-release tablet, SAR 111.65); CONCERTA EXTENDED RELEASE 36MG TABLET (36 mg, Extended-release tablet, SAR 155.10); Concentia (18 mg, Prolonged-release tablet, SAR 78.15); Concentia (36 mg, Prolonged-release tablet, SAR 108.55); Quillivant XR (40 mg, Film-coated tablet, SAR 517.00).

Is Methylphenidate approved by the US FDA?

Drugs@FDA lists 91 application product lines for Methylphenidate, including RITALIN (Prescription); METHYLPHENIDATE HYDROCHLORIDE (Prescription); METHYLIN ER (Prescription); CONCERTA (Prescription); METADATE CD (Prescription).

Is Methylphenidate authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Methylphenidate: Tuzulby.

Are there safety signals or safety updates for Methylphenidate?

EMA PRAC: 2 entries; US FDA: 15 entries; MHRA: 2 entries (latest 2026-02-02).

Active substance

Methylphenidate

SFDA 9
US FDA 91
EMA 1
Health Canada 55
US price lines 54
NHS prices 15
Safety 19

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
CONCERTA EXTENDED RELEASE 18MG TABLET	18 mg	Extended-release tablet · Oral use	30 Blister	SAR 111.65	Generic · Prescription	Janssen Cilag AG	Valid
CONCERTA EXTENDED RELEASE 36MG TABLET	36 mg	Extended-release tablet · Oral use	30 Blister	SAR 155.10	Generic · Prescription	Janssen Cilag AG	Valid
Concentia	18 mg	Prolonged-release tablet · Oral use	30 Bottle	SAR 78.15	Generic · Prescription	Exeltis Healthcare S.L	Valid
Concentia	36 mg	Prolonged-release tablet · Oral use	30 Bottle	SAR 108.55	Generic · Prescription	Exeltis Healthcare S.L	Valid
Quillivant XR	40 mg	Film-coated tablet · Oral use	100 Bottle	SAR 517.00	Prescription	SPIMACO	Valid
Quillivant XR	30 mg	Film-coated tablet · Oral use	100 Bottle	SAR 517.00	Generic · Prescription	SPIMACO	Valid
Quillivant XR	20 mg	Film-coated tablet · Oral use	100 Bottle	SAR 372.15	Generic · Prescription	SPIMACO	Valid
Quillivant XR	5 mg/ml	Powder for oral suspension · Oral use	1 Bottle	SAR 1256.00	NCE · Prescription	Saudi Pharmaceutical Industries & Medical Appliances Corporation	Valid
RITALIN TAB. 10MG	10 mg	Tablet · Oral use	30 Blister	SAR 29.30	NCE · Prescription	NOVARTIS	Valid

Indications — CHI Daman Drug Formulary

ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD); AUTISM SPECTRUM DISORDER; NARCOLEPSY AND CATAPLEXY

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

Product	Strength	Form · route	Applicant	Status	First approved
RITALIN	5MG; 10MG; 20MG	tablet · oral	SANDOZ	Prescription	5 Dec 1955
METHYLPHENIDATE HYDROCHLORIDE	5MG; 10MG; 20MG	tablet · oral	SPECGX LLC	Prescription	27 Nov 1998
METHYLIN ER	10MG; 20MG	tablet, extended release · oral	SPECGX LLC	Prescription	9 May 2000
CONCERTA	18MG; 36MG; 54MG; 27MG	tablet, extended release · oral	JANSSEN PHARMS	Prescription	1 Aug 2000
METADATE CD	20MG; 30MG; 10MG; 40MG; 50MG; 60MG	capsule, extended release · oral	LANNETT	Prescription	3 Apr 2001
RITALIN LA	20MG; 30MG; 40MG; 10MG	capsule, extended release · oral	SANDOZ	Prescription	5 Jun 2002
METHYLIN	5MG/5ML; 10MG/5ML	solution · oral	SPECGX LLC	Prescription	19 Dec 2002
DAYTRANA	10MG/9HR (1.1MG/HR); 15MG/9HR (1.6MG/HR); 20MG/9HR (2.2MG/HR); 30MG/9HR (3.3MG/HR)	film, extended release · transdermal	NOVEN PHARMS INC	Prescription	6 Apr 2006
METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML; 10MG/5ML	solution · oral	TRIS PHARMA INC	Prescription	23 Jul 2010
METHYLPHENIDATE HYDROCHLORIDE	20MG; 30MG; 40MG; 60MG	capsule, extended release · oral	DR REDDYS LABS SA	Prescription	1 Dec 2011
METHYLPHENIDATE HYDROCHLORIDE	5MG; 10MG; 20MG	tablet · oral	SUN PHARM INDS INC	Prescription	15 Mar 2012
METHYLPHENIDATE HYDROCHLORIDE	10MG; 20MG; 30MG	capsule, extended release · oral	TEVA PHARMS	Prescription	19 Jul 2012
QUILLIVANT XR	5MG/ML	for suspension, extended release · oral	NEXTWAVE	Prescription	27 Sep 2012
METHYLPHENIDATE HYDROCHLORIDE	18MG; 27MG; 36MG; 54MG	tablet, extended release · oral	LANNETT CO INC	Prescription	9 Jul 2013
METHYLPHENIDATE HYDROCHLORIDE	5MG; 10MG; 20MG	tablet · oral	OXFORD PHARMS	Prescription	23 Sep 2014
APTENSIO XR	10MG; 15MG; 20MG; 30MG; 40MG; 50MG; 60MG	capsule, extended release · oral	RHODES PHARMS	Prescription	17 Apr 2015
METHYLPHENIDATE HYDROCHLORIDE	10MG; 20MG	tablet, extended release · oral	ABHAI LLC	Prescription	9 Jun 2015
METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML; 10MG/5ML	solution · oral	NOVEL LABS INC	Prescription	14 Aug 2015
METHYLPHENIDATE HYDROCHLORIDE	5MG; 10MG; 20MG	tablet · oral	ASCENT PHARMS INC	Prescription	22 Sep 2015
METHYLPHENIDATE HYDROCHLORIDE	10MG; 20MG; 30MG; 40MG; 50MG; 60MG	capsule, extended release · oral	SPECGX LLC	Prescription	29 Sep 2015
METHYLPHENIDATE HYDROCHLORIDE	5MG; 10MG; 20MG	tablet · oral	NOVEL LABS INC	Prescription	13 Nov 2015
QUILLICHEW ER	20MG; 30MG; 40MG	tablet, extended release, chewable · oral	NEXTWAVE PHARMS	Prescription	4 Dec 2015
METHYLPHENIDATE HYDROCHLORIDE	10MG; 20MG; 30MG; 40MG; 50MG; 60MG	capsule, extended release · oral	IMPAX LABS INC	Prescription	28 Jul 2016
METHYLPHENIDATE HYDROCHLORIDE	18MG; 27MG; 36MG; 54MG	tablet, extended release · oral	AUROLIFE PHARMA LLC	Prescription	21 Oct 2016
METHYLPHENIDATE HYDROCHLORIDE	2.5MG; 5MG; 10MG	tablet, chewable · oral	RISING	Prescription	7 Nov 2016

66 more — full table

EMA European Union — centrally authorised medicines

Tuzulby Neuraxpharm Pharmaceuticals S.L. · Authorised · authorised 28 Feb 2025 · ATC N06BA04

Therapeutic indication (EMA)

Tuzulby is indicated as part of a comprehensive treatment programme for attention-deficit / hyperactivity disorder (ADHD) in children and adolescents 6-17 years old when remedial measures alone prove insufficient. Treatment must be under the supervision of a specialist in childhood behavioural disorders. Diagnosis should be made according to Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria or the guidelines in International Classification of Diseases, Tenth Revision (ICD-10) and should be based on a complete history and evaluation of the patient. Diagnosis cannot be made solely on the presence of one or more symptoms.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
AA-METHYLPHENIDATE SR	02266687	20 MG	TABLET (EXTENDED-RELEASE) · ORAL	AA PHARMA INC
ACT METHYLPHENIDATE ER	02441934	18 MG	TABLET (EXTENDED-RELEASE) · ORAL	TEVA CANADA LIMITED
ACT METHYLPHENIDATE ER	02441942	27 MG	TABLET (EXTENDED-RELEASE) · ORAL	TEVA CANADA LIMITED
ACT METHYLPHENIDATE ER	02441950	36 MG	TABLET (EXTENDED-RELEASE) · ORAL	TEVA CANADA LIMITED
ACT METHYLPHENIDATE ER	02441969	54 MG	TABLET (EXTENDED-RELEASE) · ORAL	TEVA CANADA LIMITED
APO-METHYLPHENIDATE	02249324	10 MG	TABLET · ORAL	APOTEX INC
APO-METHYLPHENIDATE	02249332	20 MG	TABLET · ORAL	APOTEX INC
APO-METHYLPHENIDATE	02273950	5 MG	TABLET · ORAL	APOTEX INC
APO-METHYLPHENIDATE ER	02330377	54 MG	TABLET (EXTENDED-RELEASE) · ORAL	APOTEX INC
APO-METHYLPHENIDATE ER	02452731	18 MG	TABLET (EXTENDED-RELEASE) · ORAL	APOTEX INC
APO-METHYLPHENIDATE ER	02452758	27 MG	TABLET (EXTENDED-RELEASE) · ORAL	APOTEX INC
APO-METHYLPHENIDATE ER	02452766	36 MG	TABLET (EXTENDED-RELEASE) · ORAL	APOTEX INC
BIPHENTIN	02277131	15 MG	CAPSULE (EXTENDED-RELEASE) · ORAL	ELVIUM LIFE SCIENCES
BIPHENTIN	02277158	20 MG	CAPSULE (EXTENDED-RELEASE) · ORAL	ELVIUM LIFE SCIENCES
BIPHENTIN	02277166	10 MG	CAPSULE (EXTENDED-RELEASE) · ORAL	ELVIUM LIFE SCIENCES
BIPHENTIN	02277174	30 MG	CAPSULE (EXTENDED-RELEASE) · ORAL	ELVIUM LIFE SCIENCES
BIPHENTIN	02277182	40 MG	CAPSULE (EXTENDED-RELEASE) · ORAL	ELVIUM LIFE SCIENCES
BIPHENTIN	02277190	50 MG	CAPSULE (EXTENDED-RELEASE) · ORAL	ELVIUM LIFE SCIENCES
BIPHENTIN	02277204	60 MG	CAPSULE (EXTENDED-RELEASE) · ORAL	ELVIUM LIFE SCIENCES
BIPHENTIN	02277212	80 MG	CAPSULE (EXTENDED-RELEASE) · ORAL	ELVIUM LIFE SCIENCES
CONCERTA	02247732	18 MG	TABLET (EXTENDED-RELEASE) · ORAL	JANSSEN INC
CONCERTA	02247733	36 MG	TABLET (EXTENDED-RELEASE) · ORAL	JANSSEN INC
CONCERTA	02247734	54 MG	TABLET (EXTENDED-RELEASE) · ORAL	JANSSEN INC
CONCERTA	02250241	27 MG	TABLET (EXTENDED-RELEASE) · ORAL	JANSSEN INC
FOQUEST	02470292	25 MG	CAPSULE (CONTROLLED-RELEASE) · ORAL	ELVIUM LIFE SCIENCES

30 more — full table

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	CONCERTA ER 18 MG TABLET	$12.32528	per EA	23 Sep 2026
US NADAC	CONCERTA ER 27 MG TABLET	$12.65426	per EA	23 Sep 2026
US NADAC	CONCERTA ER 36 MG TABLET	$13.04275	per EA	23 Sep 2026
US NADAC	CONCERTA ER 54 MG TABLET	$14.17967	per EA	23 Sep 2026
US NADAC	JORNAY PM 100 MG CAPSULE	$15.39596	per EA	23 Sep 2026
US NADAC	JORNAY PM 20 MG CAPSULE	$15.39302	per EA	23 Sep 2026
US NADAC	JORNAY PM 40 MG CAPSULE	$15.40511	per EA	23 Sep 2026
US NADAC	JORNAY PM 60 MG CAPSULE	$15.40191	per EA	23 Sep 2026
US NADAC	JORNAY PM 80 MG CAPSULE	$15.40151	per EA	23 Sep 2026
US NADAC	METHYLIN 10 MG/5 ML SOLUTION	$0.23086	per ML	23 Sep 2026
US NADAC	METHYLIN 5 MG/5 ML SOLUTION	$0.16161	per ML	23 Sep 2026
US NADAC	METHYLPHENIDATE 10 MG CHEW TAB	$2.95383	per EA	23 Sep 2026
NHS Drug Tariff	Methylphenidate 10mg modified-release capsules	£25.00	30 capsule	1 Oct 2026
NHS Drug Tariff	Methylphenidate 10mg tablets	£2.80	30 tablet	1 Oct 2026
NHS Drug Tariff	Methylphenidate 18mg modified-release tablets	£31.19	30 tablet	1 Oct 2026
NHS Drug Tariff	Methylphenidate 20mg modified-release capsules	£30.00	30 capsule	1 Oct 2026
NHS Drug Tariff	Methylphenidate 20mg tablets	£5.56	30 tablet	1 Oct 2026
NHS Drug Tariff	Methylphenidate 27mg modified-release tablets	£36.81	30 tablet	1 Oct 2026
NHS Drug Tariff	Methylphenidate 2mg/ml oral solution sugar free	£85.00	150 ml	1 Oct 2026
NHS Drug Tariff	Methylphenidate 30mg modified-release capsules	£35.00	30 capsule	1 Oct 2026
NHS Drug Tariff	Methylphenidate 36mg modified-release tablets	£42.45	30 tablet	1 Oct 2026
NHS Drug Tariff	Methylphenidate 40mg modified-release capsules	£57.72	30 capsule	1 Oct 2026
NHS Drug Tariff	Methylphenidate 50mg modified-release capsules	£62.52	30 capsule	1 Oct 2026
NHS Drug Tariff	Methylphenidate 54mg modified-release tablets	£36.80	30 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 2 Feb 2026 CONCERTA — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 23 Sep 2025 APTENSIO XR — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 23 Sep 2025 COTEMPLA XR-ODT — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 23 Sep 2025 DAYTRANA — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 23 Sep 2025 JORNAY PM — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 23 Sep 2025 METADATE CD — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 23 Sep 2025 QUILLICHEW ER — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 23 Sep 2025 QUILLIVANT XR — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 23 Sep 2025 RELEXXII — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 23 Sep 2025 RITALIN LA — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 10 Jan 2025 METHYLIN — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide
US FDA 13 Oct 2023 METHYLIN — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 13 Oct 2023 RITALIN — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 25 Jun 2021 ADHANSIA XR — safety-related labeling change
Labeling sections changed: Adverse Reactions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide
US FDA 19 Nov 2019 RITALIN-SR — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for methylphenidate →

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.