Is Zonisamide approved by the US FDA?

Drugs@FDA lists 22 application product lines for Zonisamide, including ZONEGRAN (Prescription); ZONISAMIDE (Prescription); ZONISAMIDE (Prescription); ZONISAMIDE (Prescription); ZONISAMIDE (Prescription).

Is Zonisamide authorised in the European Union?

EMA lists 2 centrally authorised medicines containing Zonisamide: Zonegran, Zonisamide Viatris (previously Zonisamide Mylan).

Are there safety signals or safety updates for Zonisamide?

US FDA: 1 entry (latest 2020-04-13).

Active substance

Zonisamide

US FDA 22
EMA 2
US price lines 4
NHS prices 4
Safety 1

Open in the medicines table

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

Product	Strength	Form · route	Applicant	Status	First approved
ZONEGRAN	100MG; 25MG	capsule · oral	ADVANZ PHARMA	Prescription	27 Mar 2000
ZONISAMIDE	100MG; 50MG; 25MG	capsule · oral	GRANULES	Prescription	22 Dec 2005
ZONISAMIDE	100MG; 25MG; 50MG	capsule · oral	AUROBINDO PHARMA LTD	Prescription	22 Dec 2005
ZONISAMIDE	25MG; 50MG; 100MG	capsule · oral	GLENMARK PHARMS	Prescription	30 Jan 2006
ZONISAMIDE	25MG; 50MG; 100MG	capsule · oral	INVAGEN PHARMS	Prescription	31 May 2006
ZONISAMIDE	25MG; 50MG; 100MG	capsule · oral	BIONPHARMA	Prescription	16 Aug 2006
ZONISAMIDE	25MG; 50MG; 100MG	capsule · oral	ZYDUS LIFESCIENCES	Prescription	16 Oct 2006
ZONISAMIDE	25MG; 50MG; 100MG	capsule · oral	UNICHEM	Prescription	26 Jan 2021
ZONISADE	100MG/5ML	suspension · oral	AZURITY	Prescription	15 Jul 2022
ZONEGRAN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	capsule · oral	ADVANZ PHARMA	Discontinued	27 Mar 2000
ZONISAMIDE	25MG; 50MG; 100MG	capsule · oral	SUN PHARM INDUSTRIES	Discontinued	22 Dec 2005
ZONISAMIDE	25MG; 50MG; 100MG	capsule · oral	RISING	Discontinued	22 Dec 2005
ZONISAMIDE	25MG; 50MG; 100MG	capsule · oral	ANI PHARMS	Discontinued	22 Dec 2005
ZONISAMIDE	100MG; 50MG; 25MG	capsule · oral	ANI PHARMS	Discontinued	22 Dec 2005
ZONISAMIDE	25MG; 50MG; 100MG	capsule · oral	APOTEX	Discontinued	22 Dec 2005
ZONISAMIDE	25MG; 50MG; 100MG	capsule · oral	UPSHER SMITH LABS	Discontinued	22 Dec 2005
ZONISAMIDE	25MG; 50MG; 100MG	capsule · oral	PHARMOBEDIENT	Discontinued	22 Dec 2005
ZONISAMIDE	25MG; 50MG; 100MG	capsule · oral	ROXANE	Discontinued	22 Dec 2005
ZONISAMIDE	25MG; 50MG; 100MG	capsule · oral	SUN PHARM INDS (IN)	Discontinued	17 Mar 2006
ZONISAMIDE	25MG; 50MG; 100MG	capsule · oral	CHARTWELL RX	Discontinued	20 Apr 2006
ZONISAMIDE	25MG; 50MG; 100MG	capsule · oral	EPIC PHARMA LLC	Discontinued	21 Feb 2007
ZONISAMIDE	25MG; 50MG; 100MG	capsule · oral	MACLEODS PHARMS	Discontinued	12 May 2025

EMA European Union — centrally authorised medicines

Zonegran Amdipharm Limited · Authorised · authorised 10 Mar 2005 · ATC N03AX15

Therapeutic indication (EMA)

Zonegran is indicated as: monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy; adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adults, adolescents, and children aged six years and above.

Zonisamide Viatris (previously Zonisamide Mylan) Viatris Limited · Authorised · authorised 31 Mar 2016 · ATC N03AX15

Therapeutic indication (EMA)

Monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy; adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adults, adolescents, and children aged 6 years and above.

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	ZONISADE 100 MG/5 ML ORAL SUSP	$2.75055	per ML	23 Sep 2026
US NADAC	ZONISAMIDE 100 MG CAPSULE	$0.10618	per EA	23 Sep 2026
US NADAC	ZONISAMIDE 25 MG CAPSULE	$0.06546	per EA	23 Sep 2026
US NADAC	ZONISAMIDE 50 MG CAPSULE	$0.0955	per EA	23 Sep 2026
NHS Drug Tariff	Zonisamide 100mg capsules	£3.52	56 capsule	1 Oct 2026
NHS Drug Tariff	Zonisamide 100mg/5ml oral suspension	£181.90	250 ml	1 Oct 2026
NHS Drug Tariff	Zonisamide 25mg capsules	£2.32	14 capsule	1 Oct 2026
NHS Drug Tariff	Zonisamide 50mg capsules	£3.49	56 capsule	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 13 Apr 2020 ZONEGRAN — 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 zonisamide →

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.