Is Levetiracetam registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 63 valid registrations of Levetiracetam, including ARPEK 250 mg film-coated tablet (250 mg, Film-coated tablet, SAR 83.45); ARPEK 500 mg film-coated tablet (500 mg, Film-coated tablet, SAR 132.55); Antagra (500 mg, Film-coated tablet, SAR 58.45); Antagra (1000 mg, Film-coated tablet, SAR 116.90); Convolt (1000 mg, Film-coated tablet, SAR 164.70).

Is Levetiracetam approved by the US FDA?

Drugs@FDA lists 116 application product lines for Levetiracetam, including KEPPRA (Prescription); KEPPRA (Prescription); KEPPRA (Prescription); KEPPRA XR (Prescription); LEVETIRACETAM (Prescription).

Is Levetiracetam authorised in the European Union?

EMA lists 9 centrally authorised medicines containing Levetiracetam: Keppra, Levetiracetam Teva, Levetiracetam ratiopharm, Matever, Levetiracetam Accord, Levetiracetam Actavis, Levetiracetam Actavis Group, Levetiracetam Sun.

Is Levetiracetam 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 Levetiracetam?

EMA PRAC: 7 entries; US FDA: 7 entries (latest 2025-06-27).

Active substance

Levetiracetam

SFDA 77
US FDA 116
EMA 10
Health Canada 44
US price lines 17
NHS prices 15
WHO EML 2
Safety 14

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
ARPEK 250 mg film-coated tablet	250 mg	Film-coated tablet · Oral use	60 Blister	SAR 83.45	Generic · Prescription	APOTEX INC. (SIGNET SITE)	Valid
ARPEK 500 mg film-coated tablet	500 mg	Film-coated tablet · Oral use	60 Blister	SAR 132.55	Generic · Prescription	APOTEX INC. (SIGNET SITE)	Valid
Antagra	500 mg	Film-coated tablet · Oral use	30 Blister	SAR 58.45	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
Antagra	1000 mg	Film-coated tablet · Oral use	30 Blister	SAR 116.90	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
Convolt	1000 mg	Film-coated tablet · Oral use	30 Blister	SAR 164.70	Generic · Prescription	LABORATORIOS CINFA SA	Valid
Convolt	1000 mg	Film-coated tablet · Oral use	60 Blister	SAR 329.40	Generic · Prescription	LABORATORIOS CINFA SA	Valid
Convolt	500 mg	Film-coated tablet · Oral use	60 Blister	SAR 164.70	Generic · Prescription	LABORATORIOS CINFA SA	Valid
Convolt	250 mg	Film-coated tablet · Oral use	60 Blister	SAR 101.00	Generic · Prescription	LABORATORIOS CINFA SA	Valid
EFRAM XR 500 mg TABLET	500 mg	Extended-release tablet · Oral use	30 Blister	SAR 91.50	Generic · Prescription	DAMMAM PHARMA	Valid
EFRAM XR 750 mg TABLET	750 mg	Extended-release tablet · Oral use	30 Blister	SAR 137.20	Generic · Prescription	DAMMAM PHARMA	Valid
EPILYRE	1000 mg	Film-coated tablet · Oral use	30 Blister	SAR 137.20	Generic · Prescription	Apex Pharma	Valid
EPILYRE	500 mg	Film-coated tablet · Oral use	30 Blister	SAR 83.95	Generic · Prescription	Apex Pharma	Valid
EPITAM 100 mg/ml I.V. Infusion	100 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 69.45	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
EPITAM 100 mg/ml syrup	100 mg/ml	Syrup · Oral use	1 Bottle	SAR 103.65	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
EPITAM 1000MG F.C.TAB	1000 mg	Film-coated tablet · Oral use	30 Blister	SAR 137.20	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
EPITAM 250 mg film-coated tablet	250 mg	Film-coated tablet · Oral use	30 Blister	SAR 59.60	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
EPITAM 500 mg film-coated tablet	500 mg	Film-coated tablet · Oral use	30 Blister	SAR 82.35	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
EPITAM 500MG PROLONGED RELEASE TABLET	500 mg	Prolonged-release tablet · Oral use	30 Bottle	SAR 82.35	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
EPITAM 750 mg film-coated tablet	750 mg	Film-coated tablet · Oral use	30 Blister	SAR 123.50	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
EPITAM 750MG PROLONGED RELEASE TABLET	750 mg	Prolonged-release tablet · Oral use	30 Bottle	SAR 123.50	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
EPIXX 100MG/ML SYRUP	100 mg/ml	Oral solution · Oral use	1 Bottle	SAR 63.10	Generic · Prescription	Abdi Ibrahim Ilac San ve Tic A.S.	Valid
Epixx	250 mg	Film-coated tablet · Oral use	50 Blister	SAR 69.55	Generic · Prescription	Abdi Ibrahim Ilac San ve Tic A.S.	Valid
Epixx	500 mg	Film-coated tablet · Oral use	50 Blister	SAR 94.85	Generic · Prescription	Abdi Ibrahim Ilac San ve Tic A.S.	Valid
Epixx	1000 mg	Film-coated tablet · Oral use	50 Blister	SAR 194.85	Generic · Prescription	Abdi Ibrahim Ilac San ve Tic A.S.	Valid
KEPAM	100 mg/ml	Solution for injection · Intravenous use	10 Vial	SAR 562.55	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid

52 more — full table

Indications — CHI Daman Drug Formulary

ABSENCE SEIZURES AND IDIOPATHIC GENERALIZED EPILEPSY; ANXIETY DISORDERS; JUVENILE MYOCLONIC SEIZURES; NAUSEA AND VOMITING IN CYCLIC VOMITING SYNDROME

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

Product	Strength	Form · route	Applicant	Status	First approved
KEPPRA	250MG; 500MG; 750MG; 1GM	tablet · oral	UCB INC	Prescription	30 Nov 1999
KEPPRA	100MG/ML	solution · oral	UCB INC	Prescription	15 Jul 2003
KEPPRA	500MG/5ML (100MG/ML)	injectable · intravenous	UCB INC	Prescription	31 Jul 2006
KEPPRA XR	500MG; 750MG	tablet, extended release · oral	UCB INC	Prescription	12 Sep 2008
LEVETIRACETAM	500MG; 750MG	tablet · oral	MYLAN	Prescription	4 Nov 2008
LEVETIRACETAM	250MG; 500MG; 750MG	tablet · oral	PHARMAZONE	Prescription	15 Jan 2009
LEVETIRACETAM	250MG; 500MG; 750MG	tablet · oral	LUPIN	Prescription	15 Jan 2009
LEVETIRACETAM	250MG; 500MG; 750MG	tablet · oral	ORBION PHARMS	Prescription	15 Jan 2009
LEVETIRACETAM	250MG; 500MG; 750MG; 1GM	tablet · oral	TORRENT PHARMS	Prescription	15 Jan 2009
LEVETIRACETAM	1GM	tablet · oral	PHARMAZONE	Prescription	15 Jan 2009
LEVETIRACETAM	100MG/ML	solution · oral	ACTAVIS MID ATLANTIC	Prescription	15 Jan 2009
LEVETIRACETAM	250MG; 500MG; 750MG; 1GM	tablet · oral	AUROBINDO PHARMA	Prescription	15 Jan 2009
LEVETIRACETAM	250MG; 500MG; 750MG; 1GM	tablet · oral	INGENUS PHARMS LLC	Prescription	15 Jan 2009
LEVETIRACETAM	100MG/ML	solution · oral	AUROBINDO PHARMA	Prescription	15 Jan 2009
LEVETIRACETAM	1GM	tablet · oral	LUPIN	Prescription	15 Jan 2009
LEVETIRACETAM	100MG/ML	solution · oral	BIONPHARMA	Prescription	16 Jan 2009
LEVETIRACETAM	250MG; 500MG; 750MG; 1GM	tablet · oral	PRINSTON INC	Prescription	10 Feb 2009
LEVETIRACETAM	100MG/ML	solution · oral	TARO	Prescription	10 Feb 2009
LEVETIRACETAM	250MG; 500MG; 750MG; 1GM	tablet · oral	NOVAX	Prescription	13 Mar 2009
LEVETIRACETAM	250MG; 500MG; 750MG	tablet · oral	OXFORD PHARMS	Prescription	20 Mar 2009
LEVETIRACETAM	100MG/ML	solution · oral	CHARTWELL MOLECULAR	Prescription	3 Apr 2009
LEVETIRACETAM	250MG; 1GM	tablet · oral	ZYDUS PHARMS USA INC	Prescription	29 Apr 2009
LEVETIRACETAM	100MG/ML	solution · oral	AMNEAL PHARMS	Prescription	27 Oct 2009
LEVETIRACETAM	1GM	tablet · oral	MYLAN	Prescription	8 Dec 2009
LEVETIRACETAM	250MG; 500MG; 750MG; 1GM	tablet · oral	RISING	Prescription	28 Jul 2010

91 more — full table

EMA European Union — centrally authorised medicines

Keppra UCB Pharma SA · Authorised · authorised 29 Sep 2000 · ATC N03AX14

Therapeutic indication (EMA)

Keppra is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy. Keppra is indicated as adjunctive therapy: in the treatment of partial-onset seizures with or without secondary generalisation in adults, children and infants from one month of age with epilepsy; in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy; in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.

Levetiracetam Teva Teva B.V. · Authorised · authorised 25 Aug 2011 · ATC N03AX14

Therapeutic indication (EMA)

Levetiracetam Teva is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in adults and adolescents from 16 years of age with newly diagnosed epilepsy. Levetiracetam Teva is indicated as adjunctive therapy: in the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents, children and infants from 1 month of age with epilepsy; in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy; in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.

Levetiracetam ratiopharm ratiopharm GmbH · Authorised · authorised 26 Aug 2011 · ATC N03AX14

Therapeutic indication (EMA)

Levetiracetam ratiopharm is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy. Levetiracetam ratiopharm is indicated as adjunctive therapy: in the treatment of partial onset seizures with or without secondary generalisation in adults, children and infants from 1 month of age with epilepsy; in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy; in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.

Matever Pharmathen S.A. · Authorised · authorised 3 Oct 2011 · ATC N03AX14

Therapeutic indication (EMA)

Matever is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy. Matever is indicated as adjunctive therapy: in the treatment of partial-onset seizures with or without secondary generalisation in adults, children and infants from one month of age with epilepsy; in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy; in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.

Levetiracetam Accord Accord Healthcare S.L.U. · Authorised · authorised 3 Oct 2011 · ATC N03AX14

Therapeutic indication (EMA)

Levetiracetam is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy. Levetiracetam is indicated as adjunctive therapy: in the treatment of partial-onset seizures with or without secondary generalisation in adults, children and infants from one month of age with epilepsy; in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy; in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.

Levetiracetam Actavis Actavis Group PTC ehf · Authorised · authorised 3 Oct 2011 · ATC N03AX14

Therapeutic indication (EMA)

Levetiracetam Actavis is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy. Levetiracetam Actavis is indicated as adjunctive therapy: in the treatment of partial-onset seizures with or without secondary generalisation in adults, children and infants from one month of age with epilepsy; in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy; in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.

Levetiracetam Actavis Group Actavis Group PTC ehf · Authorised · authorised 4 Dec 2011 · ATC N03AX14

Therapeutic indication (EMA)

Levetiracetam Actavis Group is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy. Levetiracetam Actavis Group is indicated as adjunctive therapy: in the treatment of partial-onset seizures with or without secondary generalisation in adults, children and infants from 1 month of age with epilepsy; in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy; in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.

Levetiracetam Sun Sun Pharmaceutical Industries Europe B.V. · Authorised · authorised 14 Dec 2011 · ATC N03AX14

Therapeutic indication (EMA)

Levetiracetam Sun is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy. Levetiracetam Sun is indicated as adjunctive therapy: in the treatment of partial-onset seizures with or without secondary generalisation in adults and children from four years of age with epilepsy; in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy; in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy. Levetiracetam Sun concentrate is an alternative for patients when oral administration is temporarily not feasible.

Levetiracetam Hospira Pfizer Europe MA EEIG · Authorised · authorised 7 Jan 2014 · ATC N03AX14

Therapeutic indication (EMA)

Levetiracetam Hospira is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in adults and adolescents from 16 years of age with newly diagnosed epilepsy. Levetiracetam Hospira is indicated as adjunctive therapy in the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy. in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy. in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalised Epilepsy. Levetiracetam Hospira concentrate is an alternative for patients when oral administration is temporarily not feasible.

Epixram Neuraxpharm Pharmaceuticals S.L. · Application withdrawn · ATC N03AX14

Therapeutic indication (EMA)

Treatment of partial onset seizures.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
AG-LEVETIRACETAM	02485192	250 MG	TABLET · ORAL	ANGITA PHARMA INC.
AG-LEVETIRACETAM	02485206	500 MG	TABLET · ORAL	ANGITA PHARMA INC.
AG-LEVETIRACETAM	02485214	750 MG	TABLET · ORAL	ANGITA PHARMA INC.
APO-LEVETIRACETAM	02285924	250 MG	TABLET · ORAL	APOTEX INC
APO-LEVETIRACETAM	02285932	500 MG	TABLET · ORAL	APOTEX INC
APO-LEVETIRACETAM	02285940	750 MG	TABLET · ORAL	APOTEX INC
AURO-LEVETIRACETAM	02375249	250 MG	TABLET · ORAL	AURO PHARMA INC
AURO-LEVETIRACETAM	02375257	500 MG	TABLET · ORAL	AURO PHARMA INC
AURO-LEVETIRACETAM	02375265	750 MG	TABLET · ORAL	AURO PHARMA INC
JAMP LEVETIRACETAM TABLETS	02504553	250 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
JAMP LEVETIRACETAM TABLETS	02504561	500 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
JAMP LEVETIRACETAM TABLETS	02504588	750 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
KEPPRA	02247027	250 MG	TABLET · ORAL	UCB CANADA INC
KEPPRA	02247028	500 MG	TABLET · ORAL	UCB CANADA INC
KEPPRA	02247029	750 MG	TABLET · ORAL	UCB CANADA INC
LEVETIRACETAM	02353342	250 MG	TABLET · ORAL	SANIS HEALTH INC
LEVETIRACETAM	02353350	500 MG	TABLET · ORAL	SANIS HEALTH INC
LEVETIRACETAM	02353369	750 MG	TABLET · ORAL	SANIS HEALTH INC
LEVETIRACETAM	02442531	250 MG	TABLET · ORAL	SIVEM PHARMACEUTICALS ULC
LEVETIRACETAM	02442558	500 MG	TABLET · ORAL	SIVEM PHARMACEUTICALS ULC
LEVETIRACETAM	02442566	750 MG	TABLET · ORAL	SIVEM PHARMACEUTICALS ULC
LEVETIRACETAM INJECTION USP	02527375	100 MG / ML	SOLUTION · INTRAVENOUS	STERIMAX INC
MINT-LEVETIRACETAM	02442388	250 MG	TABLET · ORAL	MINT PHARMACEUTICALS INC
MINT-LEVETIRACETAM	02442396	500 MG	TABLET · ORAL	MINT PHARMACEUTICALS INC
MINT-LEVETIRACETAM	02442418	750 MG	TABLET · ORAL	MINT PHARMACEUTICALS INC

19 more — full table

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	KEPPRA 1,000 MG TABLET	$19.8712	per EA	23 Sep 2026
US NADAC	KEPPRA 100 MG/ML ORAL SOLN	$1.91893	per ML	23 Sep 2026
US NADAC	KEPPRA 250 MG TABLET	$8.07857	per EA	23 Sep 2026
US NADAC	KEPPRA 500 MG TABLET	$9.91702	per EA	23 Sep 2026
US NADAC	KEPPRA 750 MG TABLET	$13.46136	per EA	23 Sep 2026
US NADAC	KEPPRA XR 500 MG TABLET	$9.0242	per EA	23 Sep 2026
US NADAC	KEPPRA XR 750 MG TABLET	$13.48131	per EA	23 Sep 2026
US NADAC	LEVETIRACETAM 1,000 MG TABLET	$0.15968	per EA	23 Sep 2026
US NADAC	LEVETIRACETAM 100 MG/ML SOLN	$0.03015	per ML	23 Sep 2026
US NADAC	LEVETIRACETAM 250 MG TABLET	$0.05618	per EA	23 Sep 2026
US NADAC	LEVETIRACETAM 500 MG TABLET	$0.07362	per EA	23 Sep 2026
US NADAC	LEVETIRACETAM 750 MG TABLET	$0.10924	per EA	23 Sep 2026
NHS Drug Tariff	Levetiracetam 1.5g granules for oral solution sachets sugar free	£110.73	60 sachet	1 Oct 2026
NHS Drug Tariff	Levetiracetam 100mg/ml oral solution sugar free	£4.32	300 ml	1 Oct 2026
NHS Drug Tariff	Levetiracetam 1g granules for oral solution sachets sugar free	£76.27	60 sachet	1 Oct 2026
NHS Drug Tariff	Levetiracetam 1g granules sachets sugar free	£76.27	60 sachet	1 Oct 2026
NHS Drug Tariff	Levetiracetam 1g tablets	£3.67	60 tablet	1 Oct 2026
NHS Drug Tariff	Levetiracetam 250mg granules for oral solution sachets sugar free	£22.41	60 sachet	1 Oct 2026
NHS Drug Tariff	Levetiracetam 250mg granules sachets sugar free	£22.41	60 sachet	1 Oct 2026
NHS Drug Tariff	Levetiracetam 250mg tablets	£1.39	60 tablet	1 Oct 2026
NHS Drug Tariff	Levetiracetam 500mg granules for oral solution sachets sugar free	£39.46	60 sachet	1 Oct 2026
NHS Drug Tariff	Levetiracetam 500mg granules sachets sugar free	£39.46	60 sachet	1 Oct 2026
NHS Drug Tariff	Levetiracetam 500mg tablets	£2.66	60 tablet	1 Oct 2026
NHS Drug Tariff	Levetiracetam 500mg/5ml solution for infusion ampoules	£127.31	10 ampoule	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 mL | Oral > Solid > tablet: 250 mg; 500 mg; 750 mg; 1000 mg
5.1.1. Antiseizure medicines · complementary
Status epilepticus
Parenteral > General injections > IV: 100 mg per mL in 5 mL ampoule or vial; 5 mg per mL in 100 mL bag; 10 mg per mL in 100 mL bag; 15 mg per mL in 100 mL bag

Safety signals and safety-related labeling changes

US FDA 27 Jun 2025 SPRITAM — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 12 Mar 2024 KEPPRA — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 12 Mar 2024 KEPPRA — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 12 Mar 2024 KEPPRA — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 12 Mar 2024 KEPPRA XR — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 12 Mar 2024 LEVETIRACETAM IN SODIUM CHLORIDE — 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 12 Mar 2024 ELEPSIA XR — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 29 Sep 2016 PRAC signal: Medication errors associated with accidental overdoses
Action for MAH: update of the product information: Yes
EMA PRAC 13 May 2016 PRAC signal: Medication errors associated with accidental overdoses
Action for MAH: update of the product information: No
EMA PRAC 14 Jan 2016 PRAC signal: Medication errors associated with accidental overdoses
Action for MAH: update of the product information: No
EMA PRAC 10 Sep 2015 PRAC signal: Encephalopathy
Action for MAH: update of the product information: No
EMA PRAC 7 Nov 2013 PRAC signal: Hyponatraemia and inappropriate antidiuretic hormone secretion (SIADH)
Action for MAH: update of the product information: Yes
EMA PRAC 11 Jul 2013 PRAC signal: Hyponatraemia and inappropriate antidiuretic hormone secretion (SIADH)
Action for MAH: update of the product information: No
EMA PRAC 7 Mar 2013 PRAC signal: Hyponatraemia and inappropriate antidiuretic hormone secretion (SIADH)
Action for MAH: update of the product information: No

All safety entries for levetiracetam →

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.