Is Pregabalin registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 51 valid registrations of Pregabalin, including GABEX 150 mg capsule (150 mg, Capsule, SAR 82.90); GABEX 300 mg capsule (300 mg, Capsule, SAR 129.35); GABEX 75 mg capsule (75 mg, Capsule, SAR 64.20); LEBALIN 150 MG CAPSULE (150 mg, Capsule, hard, SAR 154.75); LEBALIN 300 MG CAPSULE (300 mg, Capsule, hard, SAR 217.30).

Is Pregabalin approved by the US FDA?

Drugs@FDA lists 57 application product lines for Pregabalin, including LYRICA (Prescription); LYRICA (Prescription); LYRICA (Prescription); LYRICA (Prescription); LYRICA CR (Prescription).

Is Pregabalin authorised in the European Union?

EMA lists 6 centrally authorised medicines containing Pregabalin: Lyrica, Pregabalin Viatris Pharma (previously Pregabalin Pfizer), Pregabalin Sandoz, Pregabalin Viatris (previously Pregabalin Mylan), Pregabalin Zentiva, Pregabalin Accord.

Are there safety signals or safety updates for Pregabalin?

EMA PRAC: 4 entries; US FDA: 3 entries; MHRA: 2 entries (latest 2025-04-25).

Active substance

Pregabalin

SFDA 66
US FDA 57
EMA 9
Health Canada 109
US price lines 20
NHS prices 17
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
GABEX 150 mg capsule	150 mg	Capsule · Oral use	30 Blister	SAR 82.90	Generic · Prescription	Jamjoom Pharmaceuticals Factory Company	Valid
GABEX 300 mg capsule	300 mg	Capsule · Oral use	30 Blister	SAR 129.35	Generic · Prescription	Jamjoom Pharmaceuticals Factory Company	Valid
GABEX 75 mg capsule	75 mg	Capsule · Oral use	30 Blister	SAR 64.20	Generic · Prescription	Jamjoom Pharmaceuticals Factory Company	Valid
LEBALIN 150 MG CAPSULE	150 mg	Capsule, hard · Oral use	56 Blister	SAR 154.75	Generic · Prescription	LABORATORIOS CINFA SA	Valid
LEBALIN 300 MG CAPSULE	300 mg	Capsule, hard · Oral use	56 Blister	SAR 217.30	Generic · Prescription	LABORATORIOS CINFA SA	Valid
LEBALIN 75 MG CAPSULE	75 mg	Capsule, hard · Oral use	14 Blister	SAR 29.95	Generic · Prescription	LABORATORIOS CINFA SA	Valid
LEBALIN 75 MG CAPSULE	75 mg	Capsule, hard · Oral use	56 Blister	SAR 119.80	Generic · Prescription	LABORATORIOS CINFA SA	Valid
LYRGABA 150 mg capsule	150 mg	Capsule, hard · Oral use	40 Blister	SAR 110.55	Generic · Prescription	Middle East Pharmaceutical Industries Co Ltd Avalon Pharma	Valid
LYRGABA 150 mg capsule	150 mg	Capsule, hard · Oral use	60 Blister	SAR 165.80	Generic · Prescription	Middle East Pharmaceutical Industries Co Ltd Avalon Pharma	Valid
LYRGABA 75 mg capsule	75 mg	Capsule, hard · Oral use	40 Blister	SAR 85.60	Generic · Prescription	Middle East Pharmaceutical Industries Co Ltd Avalon Pharma	Valid
LYRGABA 75 mg capsule	75 mg	Capsule, hard · Oral use	60 Blister	SAR 128.40	Generic · Prescription	Middle East Pharmaceutical Industries Co Ltd Avalon Pharma	Valid
LYRICA 150	150 mg	Capsule, hard · Oral use	56 Blister	SAR 256.45	NCE · Prescription	Viatris Arabia Limited	Valid
LYRICA 25	25 mg	Capsule, hard · Oral use	14 Blister	SAR 18.65	NCE · Prescription	PFIZER	Valid
LYRICA 300	300 mg	Capsule, hard · Oral use	56 Blister	SAR 373.50	NCE · Prescription	Viatris Arabia Limited	Valid
LYRICA 50	50 mg	Capsule, hard · Oral use	21 Blister	SAR 43.95	NCE · Prescription	Viatris Arabia Limited	Valid
LYRICA 75	75 mg	Capsule, hard · Oral use	14 Blister	SAR 48.05	NCE · Prescription	Viatris Arabia Limited	Valid
LYRICA 75 MG CAPSULES	75 mg	Capsule, hard · Oral use	56 Blister	SAR 140.65	NCE · Prescription	Viatris Arabia Limited	Valid
Lepica	150 mg	Capsule, hard · Oral use	30 Blister	SAR 71.95	Generic · Prescription	Medical Valley Invest AB	Valid
Lepica	75 mg	Capsule, hard · Oral use	30 Blister	SAR 51.40	Generic · Prescription	Medical Valley Invest AB	Valid
Lyrgaba	75 mg	Capsule, hard · Oral use	500 Blister	SAR 1070.00	Generic · Prescription	Middle East Pharmaceutical Industries Co Ltd Avalon Pharma	Valid
Lyrgaba	150 mg	Capsule, hard · Oral use	500 Blister	SAR 1380.00	Generic · Prescription	Middle East Pharmaceutical Industries Co Ltd Avalon Pharma	Valid
NERVAX 150MG CAPSULES	150 mg	Capsule, hard · Oral use	60 Blister	SAR 219.35	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
NERVAX 300MG CAPSULES	300 mg	Capsule, hard · Oral use	60 Blister	SAR 319.45	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
NERVAX 75MG CAPSULES	75 mg	Capsule, hard · Oral use	20 Blister	SAR 58.75	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
NERVAX 75MG CAPSULES 60 capsule	75 mg	Capsule · Oral use	60 Blister	SAR 135.60	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid

41 more — full table

Indications — CHI Daman Drug Formulary

ANESTHESIA; ANXIETY DISORDERS; BURN MANAGEMENT; CHRONIC KIDNEY DISEASE-ASSOCIATED PRURITIS; DIABETIC NEUROPATHY; FIBROMYALGIA; GENERALIZED [TONIC- CLONIC- TONIC CLONIC] SEIZURES; MENOPAUSE; NEUROPATHIC PAIN; PAIN MANAGEMENT IN CANCER PATIENTS; POLYCYTHEMIA VERA - PRURITUS; POST-HERPETIC NEURALGIA; POSTOPERATIVE PAIN

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

Product	Strength	Form · route	Applicant	Status	First approved
LYRICA	25MG; 50MG; 75MG; 100MG; 150MG; 200MG; 225MG; 300MG	capsule · oral	UPJOHN	Prescription	30 Dec 2004
LYRICA	25MG; 50MG; 75MG; 100MG; 150MG; 200MG; 225MG; 300MG	capsule · oral	CP PHARMS	Prescription	30 Dec 2004
LYRICA	25MG; 50MG; 75MG; 100MG; 150MG; 200MG; 225MG; 300MG	capsule · oral	CP PHARMS	Prescription	10 Jun 2005
LYRICA	20MG/ML	solution · oral	UPJOHN	Prescription	4 Jan 2010
LYRICA CR	82.5MG; 165MG; 330MG	tablet, extended release · oral	UPJOHN	Prescription	11 Oct 2017
PREGABALIN	25MG; 50MG; 75MG; 100MG; 150MG; 200MG; 225MG; 300MG	capsule · oral	ALEMBIC	Prescription	19 Jul 2019
PREGABALIN	20MG/ML	solution · oral	ALKEM LABS LTD	Prescription	19 Jul 2019
PREGABALIN	75MG; 100MG; 150MG; 200MG; 225MG; 300MG; 25MG; 50MG	capsule · oral	ALKEM LABS LTD	Prescription	19 Jul 2019
PREGABALIN	25MG; 50MG; 75MG; 100MG; 150MG; 200MG; 225MG; 300MG	capsule · oral	SCIEGEN PHARMS	Prescription	19 Jul 2019
PREGABALIN	25MG; 50MG; 75MG; 100MG; 150MG; 200MG; 225MG; 300MG	capsule · oral	MSN	Prescription	19 Jul 2019
PREGABALIN	25MG; 50MG; 75MG; 100MG; 150MG; 200MG; 225MG; 300MG	capsule · oral	DR REDDYS	Prescription	19 Jul 2019
PREGABALIN	25MG; 50MG; 75MG; 100MG; 150MG; 200MG; 225MG; 300MG	capsule · oral	AMNEAL PHARMS CO	Prescription	19 Jul 2019
PREGABALIN	25MG; 50MG; 75MG; 100MG; 150MG; 200MG; 225MG; 300MG	capsule · oral	RISING	Prescription	19 Jul 2019
PREGABALIN	25MG; 50MG; 75MG; 100MG; 150MG; 200MG; 225MG; 300MG	capsule · oral	INVAGEN PHARMS	Prescription	19 Jul 2019
PREGABALIN	75MG; 300MG	capsule · oral	YILING	Prescription	30 Sep 2019
PREGABALIN	25MG; 50MG; 75MG; 100MG; 150MG; 200MG; 225MG; 300MG	capsule · oral	HETERO LABS LTD III	Prescription	8 Oct 2019
PREGABALIN	50MG; 75MG; 100MG; 150MG; 200MG; 300MG	capsule · oral	SOMERSET THERAPS LLC	Prescription	26 Dec 2019
PREGABALIN	50MG; 75MG; 100MG; 150MG	capsule · oral	CHARTWELL RX	Prescription	20 Mar 2020
PREGABALIN	25MG; 50MG; 75MG; 100MG; 150MG; 200MG; 225MG; 300MG	capsule · oral	CREEKWOOD PHARMS	Prescription	23 Mar 2020
PREGABALIN	82.5MG; 165MG; 330MG	tablet, extended release · oral	MSN	Prescription	13 Apr 2021
PREGABALIN	50MG; 75MG; 100MG; 150MG; 200MG; 225MG; 300MG; 25MG	capsule · oral	CHANGZHOU PHARM	Prescription	15 Jul 2021
PREGABALIN	20MG/ML	solution · oral	ANDA REPOSITORY	Prescription	18 Feb 2022
PREGABALIN	25MG; 50MG; 75MG; 100MG; 150MG; 200MG; 225MG; 300MG	capsule · oral	PHARMAZONE	Prescription	8 Mar 2022
PREGABALIN	82.5MG; 165MG; 330MG	tablet, extended release · oral	RUBICON RESEARCH	Prescription	22 Mar 2022
PREGABALIN	25MG; 50MG; 75MG; 100MG; 150MG; 200MG; 225MG; 300MG	capsule · oral	MARKSANS PHARMA	Prescription	18 Jul 2022

32 more — full table

EMA European Union — centrally authorised medicines

Lyrica Upjohn EESV · Authorised · authorised 5 Jul 2004 · ATC N02BF02

Therapeutic indication (EMA)

Neuropathic pain Lyrica is indicated for the treatment of peripheral and central neuropathic pain in adults. Epilepsy Lyrica is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. Generalised anxiety disorder Lyrica is indicated for the treatment of generalised anxiety disorder (GAD) in adults.

Pregabalin Viatris Pharma (previously Pregabalin Pfizer) Viatris Healthcare Limited · Authorised · authorised 10 Apr 2014 · ATC N02BF02

Therapeutic indication (EMA)

Neuropathic painPregabalin Viatris Pharma is indicated for the treatment of peripheral and central neuropathic pain in adults. Epilepsy Pregabalin Viatris Pharma is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. Generalised Anxiety Disorder Pregabalin Viatris Pharma is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.

Pregabalin Sandoz Sandoz GmbH · Authorised · authorised 19 Jun 2015 · ATC N02BF02

Therapeutic indication (EMA)

Neuropathic pain Pregabalin Sandoz is indicated for the treatment of peripheral and central neuropathic pain in adults. Epilepsy Pregabalin Sandoz is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. Generalised Anxiety Disorder Pregabalin Sandoz is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.

Pregabalin Viatris (previously Pregabalin Mylan) Viatris Limited · Authorised · authorised 24 Jun 2015 · ATC N02BF02

Therapeutic indication (EMA)

Neuropathic pain Pregabalin Viatris is indicated for the treatment of peripheral and central neuropathic pain in adults. EpilepsyPregabalin Viatris is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. Generalised Anxiety DisorderPregabalin Viatris is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.

Pregabalin Zentiva Zentiva k.s. · Authorised · authorised 17 Jul 2015 · ATC N02BF02

Therapeutic indication (EMA)

Neuropathic pain Pregabalin Zentiva is indicated for the treatment of peripheral and central neuropathic pain in adults. Epilepsy Pregabalin Zentiva is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. Generalised anxiety disorder Pregabalin Zentiva is indicated for the treatment of generalised anxiety disorder (GAD) in adults.

Pregabalin Accord Accord Healthcare S.L.U. · Authorised · authorised 28 Aug 2015 · ATC N03AX16

Therapeutic indication (EMA)

Epilepsy Pregabalin Accord is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. Generalised Anxiety Disorder Pregabalin Accord is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.

Pregabalin Sandoz GmbH Sandoz GmbH · Withdrawn · authorised 19 Jun 2015 · ATC N03AX16

Therapeutic indication (EMA)

Epilepsy Pregabalin Sandoz GmbH is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. Generalised Anxiety Disorder Pregabalin Sandoz GmbH is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.

Pregabalin Mylan Pharma Mylan S.A.S. · Withdrawn · authorised 25 Jun 2015 · ATC N03AX16

Therapeutic indication (EMA)

Epilepsy Pregabalin Mylan Pharma is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. Generalised Anxiety Disorder Pregabalin Mylan Pharma is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.

Pregabalin Zentiva k.s. Zentiva k.s. · Withdrawn · authorised 27 Feb 2017 · ATC N03AX16

Therapeutic indication (EMA)

Neuropathic pain Pregabalin Zentiva k.s. is indicated for the treatment of peripheral and central neuropathic pain in adults. Epilepsy Pregabalin Zentiva k.s. is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. Generalised anxiety disorder Pregabalin Zentiva k.s. is indicated for the treatment of generalised anxiety disorder (GAD) in adults.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ACH-PREGABALIN	02449838	25 MG	CAPSULE · ORAL	ACCORD HEALTHCARE INC
ACH-PREGABALIN	02449846	50 MG	CAPSULE · ORAL	ACCORD HEALTHCARE INC
ACH-PREGABALIN	02449854	75 MG	CAPSULE · ORAL	ACCORD HEALTHCARE INC
ACH-PREGABALIN	02449870	150 MG	CAPSULE · ORAL	ACCORD HEALTHCARE INC
ACH-PREGABALIN	02449900	300 MG	CAPSULE · ORAL	ACCORD HEALTHCARE INC
AG-PREGABALIN	02480727	25 MG	CAPSULE · ORAL	ANGITA PHARMA INC.
AG-PREGABALIN	02480735	50 MG	CAPSULE · ORAL	ANGITA PHARMA INC.
AG-PREGABALIN	02480743	75 MG	CAPSULE · ORAL	ANGITA PHARMA INC.
AG-PREGABALIN	02480751	150 MG	CAPSULE · ORAL	ANGITA PHARMA INC.
AG-PREGABALIN	02480778	300 MG	CAPSULE · ORAL	ANGITA PHARMA INC.
APO-PREGABALIN	02394243	50 MG	CAPSULE · ORAL	APOTEX INC
APO-PREGABALIN	02394278	150 MG	CAPSULE · ORAL	APOTEX INC
AURO-PREGABALIN	02433869	25 MG	CAPSULE · ORAL	AURO PHARMA INC
AURO-PREGABALIN	02433877	50 MG	CAPSULE · ORAL	AURO PHARMA INC
AURO-PREGABALIN	02433885	75 MG	CAPSULE · ORAL	AURO PHARMA INC
AURO-PREGABALIN	02433907	150 MG	CAPSULE · ORAL	AURO PHARMA INC
BIO-PREGABALIN	02541122	25 MG	CAPSULE · ORAL	BIOMED PHARMA
BIO-PREGABALIN	02541130	50 MG	CAPSULE · ORAL	BIOMED PHARMA
BIO-PREGABALIN	02541149	75 MG	CAPSULE · ORAL	BIOMED PHARMA
BIO-PREGABALIN	02541165	150 MG	CAPSULE · ORAL	BIOMED PHARMA
BIO-PREGABALIN	02541203	300 MG	CAPSULE · ORAL	BIOMED PHARMA
JAMP-PREGABALIN	02435977	25 MG	CAPSULE · ORAL	JAMP PHARMA CORPORATION
JAMP-PREGABALIN	02435985	50 MG	CAPSULE · ORAL	JAMP PHARMA CORPORATION
JAMP-PREGABALIN	02435993	75 MG	CAPSULE · ORAL	JAMP PHARMA CORPORATION
JAMP-PREGABALIN	02436000	150 MG	CAPSULE · ORAL	JAMP PHARMA CORPORATION

84 more — full table

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	LYRICA 100 MG CAPSULE	$9.69564	per EA	23 Sep 2026
US NADAC	LYRICA 150 MG CAPSULE	$9.68758	per EA	23 Sep 2026
US NADAC	LYRICA 200 MG CAPSULE	$9.68209	per EA	23 Sep 2026
US NADAC	LYRICA 225 MG CAPSULE	$9.68449	per EA	23 Sep 2026
US NADAC	LYRICA 25 MG CAPSULE	$9.68549	per EA	23 Sep 2026
US NADAC	LYRICA 300 MG CAPSULE	$9.67502	per EA	23 Sep 2026
US NADAC	LYRICA 50 MG CAPSULE	$9.68419	per EA	23 Sep 2026
US NADAC	LYRICA 75 MG CAPSULE	$9.67102	per EA	23 Sep 2026
US NADAC	PREGABALIN 100 MG CAPSULE	$0.05709	per EA	23 Sep 2026
US NADAC	PREGABALIN 150 MG CAPSULE	$0.05421	per EA	23 Sep 2026
US NADAC	PREGABALIN 20 MG/ML SOLUTION	$0.15295	per ML	23 Sep 2026
US NADAC	PREGABALIN 200 MG CAPSULE	$0.05935	per EA	23 Sep 2026
NHS Drug Tariff	Pregabalin 100mg capsules	£1.90	84 capsule	1 Oct 2026
NHS Drug Tariff	Pregabalin 100mg tablets	£13.87	84 tablet	1 Oct 2026
NHS Drug Tariff	Pregabalin 150mg capsules	£2.06	56 capsule	1 Oct 2026
NHS Drug Tariff	Pregabalin 150mg tablets	£14.17	56 tablet	1 Oct 2026
NHS Drug Tariff	Pregabalin 200mg capsules	£2.68	84 capsule	1 Oct 2026
NHS Drug Tariff	Pregabalin 200mg tablets	£17.71	84 tablet	1 Oct 2026
NHS Drug Tariff	Pregabalin 20mg/ml oral solution sugar free	£27.94	473 ml	1 Oct 2026
NHS Drug Tariff	Pregabalin 225mg capsules	£2.93	56 capsule	1 Oct 2026
NHS Drug Tariff	Pregabalin 225mg tablets	£6.39	56 tablet	1 Oct 2026
NHS Drug Tariff	Pregabalin 25mg capsules	£1.33	56 capsule	1 Oct 2026
NHS Drug Tariff	Pregabalin 25mg tablets	£10.71	56 tablet	1 Oct 2026
NHS Drug Tariff	Pregabalin 300mg capsules	£2.70	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 25 Apr 2025 LYRICA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 25 Apr 2025 LYRICA — 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 25 Apr 2025 LYRICA CR — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
MHRA 19 Apr 2022 Pregabalin (Lyrica): findings of safety study on risks during pregnancy
A new study has suggested pregabalin may slightly increase the risk of major congenital malformations if used in pregnancy. Patients should continue to use effective contraception during treatment and avoid use in pregnancy unless clearly necessary.
EMA PRAC 13 Jan 2022 PRAC signal: Toxic epidermal necrolysis
Action for MAH: update of the product information: Yes
EMA PRAC 2 Sep 2021 PRAC signal: Toxic epidermal necrolysis
Action for MAH: update of the product information: No
MHRA 18 Feb 2021 Pregabalin (Lyrica): reports of severe respiratory depression
Pregabalin has been associated with infrequent reports of severe respiratory depression, including some cases without the presence of concomitant opioid medicines. Patients with compromised respiratory function, respiratory or neurological disease, renal impairment; those using concomitant central nervous system (CNS) depressants; and people older than 65 years might be at higher risk of experiencing these events and adjustments in dose or dosing regimen may be necessary.
EMA PRAC 17 Jan 2019 PRAC signal: Respiratory depression with and without concomitant opioid use
Action for MAH: update of the product information: No
EMA PRAC 11 Jun 2015 PRAC signal: Hyponatremia and syndrome of inappropriate antidiuretic hormone (SIADH)
Action for MAH: update of the product information: No

All safety entries for pregabalin →

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.