Is Carbamazepine registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 8 valid registrations of Carbamazepine, including CARBATOL 200MG TAB (200 mg, Film-coated tablet, SAR 12.75); Carbalept (400 mg, Prolonged-release tablet, SAR 31.20); Carbalept (200 mg, Prolonged-release tablet, SAR 22.00); Carbatol (200 mg, Film-coated tablet, SAR 145.00); TEGRETOL 2% oral suspension (2 mg/ml, Oral suspension, SAR 21.90).

Is Carbamazepine approved by the US FDA?

Drugs@FDA lists 52 application product lines for Carbamazepine, including TEGRETOL (Prescription); TEGRETOL (Prescription); EPITOL (Prescription); TEGRETOL-XR (Prescription); CARBAMAZEPINE (Prescription).

Is Carbamazepine on the WHO Model List of Essential Medicines?

Yes — 5.1.1. Antiseizure medicines (core list): Epilepsy or seizures.

Are there safety signals or safety updates for Carbamazepine?

EMA PRAC: 2 entries; US FDA: 7 entries (latest 2026-07-15).

Active substance

Carbamazepine

SFDA 15
US FDA 52
Health Canada 11
US price lines 20
NHS prices 8
WHO EML 2
Safety 9

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
CARBATOL 200MG TAB	200 mg	Film-coated tablet · Oral use	30 Blister	SAR 12.75	Generic · Prescription	DAR ALDAWA	Valid
Carbalept	400 mg	Prolonged-release tablet · Oral use	30 Bottle	SAR 31.20	Generic · Prescription	SAUDI PHARMACEUTICAL INDUSTRIES	Valid
Carbalept	200 mg	Prolonged-release tablet · Oral use	30 Bottle	SAR 22.00	Generic · Prescription	SAUDI PHARMACEUTICAL INDUSTRIES	Valid
Carbatol	200 mg	Film-coated tablet · Oral use	500 Blister	SAR 145.00	Generic · Prescription	DAR Al DAWA	Valid
TEGRETOL 2% oral suspension	2 mg/ml	Oral suspension · Oral use	1 Bottle	SAR 21.90	NCE · Prescription	NOVARTIS	Valid
TEGRETOL CR 200MG SCORED TAB	200 mg	Prolonged-release tablet · Oral use	50 Blister	SAR 40.75	NCE · Prescription	NOVARTIS PHARMA AG	Valid
TEGRETOL CR 400MG SCORED TAB	400 mg	Prolonged-release tablet · Oral use	30 Blister	SAR 34.70	NCE · Prescription	NOVARTIS	Valid
TEGRETOL TAB 200MG	200 mg	Tablet · Oral use	50 Blister	SAR 30.10	NCE · Prescription	NOVARTIS	Valid
EPTOL 100MG-5ML ORAL SUSPENSION	20 mg/ml	Oral suspension · Oral use	1 Bottle	SAR 13.30	NCE · Prescription	Tabuk Pharmaceutical Manufacturing Company	Withdrawn by MAH · Not Marketed
EPTOL 200 MG TAB	200 mg	Tablet · Oral use	30 Blister	SAR 20.90	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Withdrawn by MAH · Not Marketed
FITZCALM 200MG TAB	200 mg	Tablet · Oral use	50 Blister	SAR 31.35	Generic · Prescription	Gulf Pharmaceutical Industries (Julphar)	Withdrawn by MAH · Not Marketed
FITZECALM 100MG\5ML SUSP	20 mg/ml	Suspension · Oral use	1 Bottle	SAR 11.90	Generic · Prescription	Gulf Pharmaceutical Industries (Julphar)	Withdrawn by MAH · Not Marketed
TEGRETOL 100 CHEW.TAB	100 mg	Chewable tablet · Oral use	50 Blister	SAR 23.90	NCE · Prescription	NOVARTIS	Withdrawn by MAH · Not Marketed
TEGRETOL 250 MG SUPPOSITORIES	250 mg	Suppository · Rectal use	5 Blister	SAR 58.35	NCE · Prescription	NOVARTIS	Withdrawn by MAH · Not Marketed
TEGRETOL CR 200MG SCORED TAB	200 mg	Prolonged-release tablet · Oral use	50 Blister	SAR 47.15	NCE · Prescription	NOVARTIS	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

ACUTE BIPOLAR I DEPRESSION; ACUTE MANIA; ANXIETY DISORDERS; BIPOLAR I DISORDER MAINTENANCE; BIPOLAR II DISORDER; GENERALIZED [TONIC- CLONIC- TONIC CLONIC] SEIZURES; TRIGEMINAL NEURALGIA

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

Product	Strength	Form · route	Applicant	Status	First approved
TEGRETOL	200MG	tablet · oral	NOVARTIS	Prescription	11 Mar 1968
TEGRETOL	100MG/5ML	suspension · oral	NOVARTIS	Prescription	18 Dec 1987
EPITOL	100MG	tablet, chewable · oral	TEVA	Prescription	29 Jul 1992
TEGRETOL-XR	100MG; 200MG; 400MG	tablet, extended release · oral	NOVARTIS	Prescription	25 Mar 1996
CARBAMAZEPINE	200MG	tablet · oral	TARO	Prescription	3 Oct 1996
CARBATROL	200MG; 300MG; 100MG	capsule, extended release · oral	TAKEDA PHARMS USA	Prescription	30 Sep 1997
CARBAMAZEPINE	100MG; 200MG	tablet, chewable · oral	TARO PHARM INDS	Prescription	24 Oct 2000
CARBAMAZEPINE	100MG	tablet, chewable · oral	TORRENT PHARMS	Prescription	5 Jul 2001
CARBAMAZEPINE	200MG	tablet · oral	APOTEX	Prescription	27 Feb 2002
CARBAMAZEPINE	100MG/5ML	suspension · oral	CHARTWELL RX	Prescription	5 Jun 2002
TERIL	100MG/5ML	suspension · oral	TARO	Prescription	20 Sep 2004
EQUETRO	100MG; 200MG; 300MG	capsule, extended release · oral	VALIDUS PHARMS	Prescription	10 Dec 2004
CARBAMAZEPINE	200MG	tablet · oral	TORRENT PHARMS	Prescription	7 Dec 2005
CARBAMAZEPINE	100MG; 200MG; 400MG	tablet, extended release · oral	TARO	Prescription	31 Mar 2009
CARBAMAZEPINE	100MG; 200MG; 300MG	capsule, extended release · oral	ANI PHARMS	Prescription	20 May 2011
CARBAMAZEPINE	100MG; 200MG; 300MG	capsule, extended release · oral	APOTEX INC	Prescription	25 Nov 2011
CARBAMAZEPINE	100MG; 200MG; 300MG	capsule, extended release · oral	TEVA PHARMS	Prescription	20 Sep 2012
CARBAMAZEPINE	100MG; 200MG; 400MG	tablet, extended release · oral	ZYDUS PHARMS	Prescription	7 Feb 2019
CARBAMAZEPINE	100MG; 200MG	tablet · oral	UMEDICA	Prescription	15 Apr 2020
CARBAMAZEPINE	100MG; 200MG; 400MG	tablet, extended release · oral	UNIQUE PHARM	Prescription	24 Apr 2020
CARBAMAZEPINE	100MG; 200MG; 400MG	tablet, extended release · oral	CSPC OUYI	Prescription	13 Apr 2021
CARBAMAZEPINE	100MG; 200MG; 400MG	tablet, extended release · oral	ANBISON LAB	Prescription	30 Sep 2021
CARBAMAZEPINE	100MG; 200MG; 400MG	tablet, extended release · oral	ZHEJIANG JIUZHOU	Prescription	31 Mar 2022
CARBAMAZEPINE	100MG; 200MG; 400MG	tablet, extended release · oral	UMEDICA	Prescription	18 Aug 2022
CARBAMAZEPINE	200MG	tablet · oral	UNICHEM	Prescription	22 Aug 2022

27 more — full table

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
MINT-CARBAMAZEPINE	02541238	200 MG	TABLET · ORAL	MINT PHARMACEUTICALS INC
SANDOZ-CARBAMAZEPINE CR	02261839	200 MG	TABLET (EXTENDED-RELEASE) · ORAL	SANDOZ CANADA INCORPORATED
SANDOZ-CARBAMAZEPINE CR	02261847	400 MG	TABLET (EXTENDED-RELEASE) · ORAL	SANDOZ CANADA INCORPORATED
TARO-CARBAMAZEPINE	02367394	100 MG / 5 ML	SUSPENSION · ORAL	TARO PHARMACEUTICALS INC
TARO-CARBAMAZEPINE CHEWABLE TABLETS	02244403	100 MG	TABLET (CHEWABLE) · ORAL	TARO PHARMACEUTICALS INC
TARO-CARBAMAZEPINE CHEWABLE TABLETS	02244404	200 MG	TABLET (CHEWABLE) · ORAL	TARO PHARMACEUTICALS INC
TEGRETOL	00010405	200 MG	TABLET · ORAL	NOVARTIS PHARMACEUTICALS CANADA INC
TEGRETOL CR	00755583	400 MG	TABLET (EXTENDED-RELEASE) · ORAL	NOVARTIS PHARMACEUTICALS CANADA INC
TEGRETOL CR	00773611	200 MG	TABLET (EXTENDED-RELEASE) · ORAL	NOVARTIS PHARMACEUTICALS CANADA INC
TEGRETOL SUSPENSION	02194333	100 MG / 5 ML	SUSPENSION · ORAL	NOVARTIS PHARMACEUTICALS CANADA INC
TEVA-CARBAMAZEPINE	00782718	200 MG	TABLET · ORAL	TEVA CANADA LIMITED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	CARBAMAZEPINE 100 MG TAB CHEW	$0.24261	per EA	23 Sep 2026
US NADAC	CARBAMAZEPINE 100 MG/5 ML SUSP	$0.09255	per ML	23 Sep 2026
US NADAC	CARBAMAZEPINE 200 MG TABLET	$0.11939	per EA	23 Sep 2026
US NADAC	CARBAMAZEPINE ER 100 MG CAP	$1.06785	per EA	23 Sep 2026
US NADAC	CARBAMAZEPINE ER 100 MG TABLET	$0.20207	per EA	23 Sep 2026
US NADAC	CARBAMAZEPINE ER 200 MG CAP	$1.05271	per EA	23 Sep 2026
US NADAC	CARBAMAZEPINE ER 200 MG TABLET	$0.39888	per EA	23 Sep 2026
US NADAC	CARBAMAZEPINE ER 300 MG CAP	$1.07458	per EA	23 Sep 2026
US NADAC	CARBAMAZEPINE ER 400 MG TABLET	$0.65275	per EA	23 Sep 2026
US NADAC	CARBATROL ER 100 MG CAPSULE	$1.69958	per EA	23 Sep 2026
US NADAC	CARBATROL ER 200 MG CAPSULE	$1.69319	per EA	23 Sep 2026
US NADAC	CARBATROL ER 300 MG CAPSULE	$1.6954	per EA	23 Sep 2026
NHS Drug Tariff	Carbamazepine 100mg tablets	£2.07	84 tablet	1 Oct 2026
NHS Drug Tariff	Carbamazepine 100mg/5ml oral suspension sugar free	£13.19	300 ml	1 Oct 2026
NHS Drug Tariff	Carbamazepine 125mg suppositories	£123.60	5 suppository	1 Oct 2026
NHS Drug Tariff	Carbamazepine 200mg modified-release tablets	£5.20	56 tablet	1 Oct 2026
NHS Drug Tariff	Carbamazepine 200mg tablets	£3.83	84 tablet	1 Oct 2026
NHS Drug Tariff	Carbamazepine 250mg suppositories	£190.87	5 suppository	1 Oct 2026
NHS Drug Tariff	Carbamazepine 400mg modified-release tablets	£10.24	56 tablet	1 Oct 2026
NHS Drug Tariff	Carbamazepine 400mg tablets	£5.02	56 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.

WHO WHO Model List of Essential Medicines (2025)

5.1.1. Antiseizure medicines · core
Epilepsy or seizures
Oral > Liquid: 100 mg per 5 mL | Oral > Solid > tablet: 100 mg (scored); 200 mg (scored); 100 mg (chewable); 200 mg (chewable); 400 mg (scored)
24.2.2. Medicines for bipolar disorders · core
Bipolar or related disorders
Oral > Solid > tablet: 100 mg (scored); 200 mg (scored); 400 mg

Safety signals and safety-related labeling changes

US FDA 15 Jul 2026 TEGRETOL — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 15 Jul 2026 TEGRETOL — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 15 Jul 2026 TEGRETOL-XR — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 11 Apr 2023 CARBATROL — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 14 Oct 2022 EQUETRO — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 13 Dec 2019 CARNEXIV — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 4 Oct 2018 PRAC signal: Drug interaction between oxybutynin and carbamazepine resulting in seizures and carbamazepine overdose secondary to carbamazepine plasma level variations
Action for MAH: update of the product information: No
EMA PRAC 17 May 2018 PRAC signal: Drug interaction between oxybutynin and carbamazepine resulting in seizures and carbamazepine overdose secondary to carbamazepine plasma level variations
Action for MAH: update of the product information: No
US FDA 20 Mar 2018 TEGRETOL — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for carbamazepine →

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.