Is Gabapentin registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 25 valid registrations of Gabapentin, including CONVENTIN 300 mg Capsule (300 mg, Capsule, SAR 32.10); CONVENTIN 400 mg Capsule (400 mg, Capsule, SAR 35.70); GABANET 300MG CAPSULE (300 mg, Capsule, SAR 53.15); GABANET 400MG CAPSULE (400 mg, Capsule, SAR 61.90); GABIN 100MG CAPSULE (100 mg, Capsule, SAR 70.85).

Is Gabapentin approved by the US FDA?

Drugs@FDA lists 79 application product lines for Gabapentin, including NEURONTIN (Prescription); NEURONTIN (Prescription); NEURONTIN (Prescription); NEURONTIN (Prescription); NEURONTIN (Prescription).

Are there safety signals or safety updates for Gabapentin?

EMA PRAC: 5 entries; US FDA: 4 entries; MHRA: 1 entry (latest 2025-04-25).

Active substance

Gabapentin

SFDA 33
US FDA 79
Health Canada 59
US price lines 20
NHS prices 6
Safety 10

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
CONVENTIN 300 mg Capsule	300 mg	Capsule · Oral use	30 Blister	SAR 32.10	Generic · Prescription	EVA PHARMA	Valid
CONVENTIN 400 mg Capsule	400 mg	Capsule · Oral use	30 Blister	SAR 35.70	Generic · Prescription	EVA PHARMA	Valid
GABANET 300MG CAPSULE	300 mg	Capsule · Oral use	48 Blister	SAR 53.15	Generic · Prescription	The Jordanian Pharmaceutical Manufacturing Medical Equipment Co. Ltd. (JPM)	Valid
GABANET 400MG CAPSULE	400 mg	Capsule · Oral use	48 Blister	SAR 61.90	Generic · Prescription	The Jordanian Pharmaceutical Manufacturing Medical Equipment Co. Ltd. (JPM)	Valid
GABIN 100MG CAPSULE	100 mg	Capsule · Oral use	100 Blister	SAR 70.85	Generic · Prescription	DEEF PHARMACEUTICAL INDUSTRIES	Valid
GABIN 100MG CAPSULE	100 mg	Capsule · Oral use	20 Blister	SAR 14.15	Generic · Prescription	DEEF PHARMACEUTICAL INDUSTRIES	Valid
GABIN 300MG CAPSULE	300 mg	Capsule · Oral use	100 Blister	SAR 145.45	Generic · Prescription	DEEF PHARMACEUTICAL INDUSTRIES	Valid
GABIN 300MG CAPSULE	300 mg	Capsule · Oral use	50 Blister	SAR 72.70	Generic · Prescription	DEEF PHARMACEUTICAL INDUSTRIES	Valid
GABIN 400MG CAPSULE	400 mg	Capsule · Oral use	100 Blister	SAR 170.90	Generic · Prescription	DEEF PHARMACEUTICAL INDUSTRIES	Valid
GABIN 400MG CAPSULE	400 mg	Capsule · Oral use	50 Blister	SAR 85.45	Generic · Prescription	DEEF PHARMACEUTICAL INDUSTRIES	Valid
GAPENTIN	400 mg	Capsule · Oral use	50 Blister	SAR 105.50	Generic · Prescription	RIYADH PHARMA	Valid
GAPENTIN	300 mg	Capsule · Oral use	50 Blister	SAR 89.80	Generic · Prescription	RIYADH PHARMA	Valid
Gabanet	300 mg	Capsule · Oral use	768 Blister	SAR 735.45	Generic · Prescription	The Jordanian Pharmaceutical Manufacturing Medical Equipment Co. Ltd. (JPM)	Valid
Gabanet	400 mg	Capsule · Oral use	504 Blister	SAR 639.55	Generic · Prescription	The Jordanian Pharmaceutical Manufacturing Medical Equipment Co. Ltd. (JPM)	Valid
NEURONTIN	400 mg	Capsule, hard · Oral use	50 Blister	SAR 128.10	NCE · Prescription	Viatris Arabia Limited	Valid
NEURONTIN	300 mg	Capsule, hard · Oral use	50 Blister	SAR 109.50	NCE · Prescription	Viatris Arabia Limited	Valid
NEUROPLEX 300MG CAPSULES	300 mg	Capsule · Oral use	50 Blister	SAR 80.80	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
NEUROPLEX 400MG CAPSULES	400 mg	Capsule · Oral use	50 Blister	SAR 94.95	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
NULEX 100 mg Capsule	100 mg	Capsule · Oral use	20 Blister	SAR 12.75	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
NULEX 300 mg Capsule	300 mg	Capsule · Oral use	50 Blister	SAR 65.40	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
NULEX 400 mg Capsule	400 mg	Capsule · Oral use	50 Blister	SAR 76.90	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
NULEX 600 mg Film Coated Tablet	600 mg	Film-coated tablet · Oral use	30 Blister	SAR 69.20	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
NULEX 800 mg Film Coated Tablet	800 mg	Film-coated tablet · Oral use	30 Blister	SAR 92.30	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
Pentix	300 mg	Capsule · Oral use	30 Blister	SAR 39.25	Generic · Prescription	Med City Pharma	Valid
Pentix	400 mg	Capsule · Oral use	30 Blister	SAR 46.15	Generic · Prescription	Med City Pharma	Valid

8 more — full table

Indications — CHI Daman Drug Formulary

ANESTHESIA; ANXIETY DISORDERS; BIPOLAR I DISORDER MAINTENANCE; BURN MANAGEMENT; CHRONIC KIDNEY DISEASE-ASSOCIATED PRURITIS; DIABETIC NEUROPATHY; EPIDERMOLYSIS BULLOSA; FIBROMYALGIA; GENERALIZED [TONIC- CLONIC- TONIC CLONIC] SEIZURES; MULTIPLE SCLEROSIS; NEUROPATHIC PAIN; PAIN MANAGEMENT IN CANCER PATIENTS; POLYCYTHEMIA VERA - PRURITUS; POST-HERPETIC NEURALGIA; POSTOPERATIVE NAUSEA AND VOMITING; POSTOPERATIVE PAIN; SICKLE CELL DISEASE - PAIN MANAGEMENT; SPASTICITY; TRIGEMINAL NEURALGIA

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

Product	Strength	Form · route	Applicant	Status	First approved
NEURONTIN	100MG; 300MG; 400MG	capsule · oral	VIATRIS	Prescription	30 Dec 1993
NEURONTIN	600MG; 800MG	tablet · oral	VIATRIS	Prescription	9 Oct 1998
NEURONTIN	250MG/5ML	solution · oral	VIATRIS	Prescription	2 Mar 2000
NEURONTIN	250MG/5ML	solution · oral	PARKE DAVIS	Prescription	12 Oct 2000
NEURONTIN	600MG	tablet · oral	PARKE DAVIS	Prescription	24 May 2002
NEURONTIN	800MG	tablet · oral	PARKE DAVIS	Prescription	24 May 2002
NEURONTIN	250MG/5ML	solution · oral	PARKE DAVIS	Prescription	24 May 2002
GABAPENTIN	100MG; 300MG; 400MG	capsule · oral	ACTAVIS ELIZABETH	Prescription	12 Sep 2003
GABAPENTIN	100MG; 300MG; 400MG	tablet · oral	IVAX SUB TEVA PHARMS	Prescription	28 Apr 2004
GABAPENTIN	100MG; 300MG; 400MG	capsule · oral	CSPC OUYI	Prescription	23 Mar 2005
GABAPENTIN	100MG; 300MG; 400MG	capsule · oral	GRANULES	Prescription	6 Apr 2005
GABAPENTIN	600MG; 800MG	tablet · oral	GLENMARK PHARMS LTD	Prescription	18 Aug 2006
GABAPENTIN	600MG; 800MG	tablet · oral	RUBICON RESEARCH	Prescription	13 Sep 2006
GABAPENTIN	100MG; 300MG; 400MG	capsule · oral	AMNEAL PHARMS NY	Prescription	25 Jul 2007
GABAPENTIN	100MG; 300MG; 400MG	capsule · oral	AUROBINDO PHARMA	Prescription	31 Jan 2008
GABAPENTIN	100MG; 300MG; 400MG	capsule · oral	INVAGEN PHARMS	Prescription	30 Dec 2009
GABAPENTIN	100MG; 300MG; 400MG	capsule · oral	ALKEM	Prescription	17 Dec 2010
GRALISE	300MG; 600MG; 450MG; 750MG; 900MG	tablet · oral	ALMATICA	Prescription	28 Jan 2011
GABAPENTIN	600MG; 800MG	tablet · oral	ZYDUS PHARMS USA INC	Prescription	11 Feb 2011
GABAPENTIN	250MG/5ML	solution · oral	MISSION PHARMACAL	Prescription	18 Feb 2011
GABAPENTIN	100MG; 300MG; 400MG	capsule · oral	MARKSANS PHARMA	Prescription	21 Jul 2011
GABAPENTIN	600MG; 800MG	tablet · oral	AUROBINDO PHARMA LTD	Prescription	6 Oct 2011
GABAPENTIN	250MG/5ML	solution · oral	AMNEAL PHARMS	Prescription	23 Mar 2012
GABAPENTIN	250MG/5ML	solution · oral	ACELLA PHARMS LLC	Prescription	1 May 2012
GABAPENTIN	800MG; 600MG	tablet · oral	STRIDES PHARMA	Prescription	12 Jul 2013

54 more — full table

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ACH-GABAPENTIN	02392526	600 MG	TABLET · ORAL	ACCORD HEALTHCARE INC
ACH-GABAPENTIN	02416840	100 MG	CAPSULE · ORAL	ACCORD HEALTHCARE INC
ACH-GABAPENTIN	02416859	300 MG	CAPSULE · ORAL	ACCORD HEALTHCARE INC
ACH-GABAPENTIN	02416867	400 MG	CAPSULE · ORAL	ACCORD HEALTHCARE INC
APO-GABAPENTIN	02244304	100 MG	CAPSULE · ORAL	APOTEX INC
APO-GABAPENTIN	02244305	300 MG	CAPSULE · ORAL	APOTEX INC
APO-GABAPENTIN	02244306	400 MG	CAPSULE · ORAL	APOTEX INC
APO-GABAPENTIN	02293358	600 MG	TABLET · ORAL	APOTEX INC
APO-GABAPENTIN	02293366	800 MG	TABLET · ORAL	APOTEX INC
AURO-GABAPENTIN	02321203	100 MG	CAPSULE · ORAL	AURO PHARMA INC
AURO-GABAPENTIN	02321211	300 MG	CAPSULE · ORAL	AURO PHARMA INC
AURO-GABAPENTIN	02321238	400 MG	CAPSULE · ORAL	AURO PHARMA INC
AURO-GABAPENTIN TABLETS	02428334	600 MG	TABLET · ORAL	AURO PHARMA INC
AURO-GABAPENTIN TABLETS	02428342	800 MG	TABLET · ORAL	AURO PHARMA INC
GABAPENTIN	02246314	100 MG	CAPSULE · ORAL	SIVEM PHARMACEUTICALS ULC
GABAPENTIN	02246315	300 MG	CAPSULE · ORAL	SIVEM PHARMACEUTICALS ULC
GABAPENTIN	02246316	400 MG	CAPSULE · ORAL	SIVEM PHARMACEUTICALS ULC
GABAPENTIN	02353245	100 MG	CAPSULE · ORAL	SANIS HEALTH INC
GABAPENTIN	02353253	300 MG	CAPSULE · ORAL	SANIS HEALTH INC
GABAPENTIN	02353261	400 MG	CAPSULE · ORAL	SANIS HEALTH INC
GABAPENTIN	02388200	600 MG	TABLET · ORAL	SIVEM PHARMACEUTICALS ULC
GABAPENTIN	02388219	800 MG	TABLET · ORAL	SIVEM PHARMACEUTICALS ULC
GABAPENTIN	02431289	600 MG	TABLET · ORAL	SANIS HEALTH INC
GABAPENTIN	02432072	600 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
GABAPENTIN	02432080	800 MG	TABLET · ORAL	JAMP PHARMA CORPORATION

34 more — full table

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	GABAPENTIN 100 MG CAPSULE	$0.02184	per EA	23 Sep 2026
US NADAC	GABAPENTIN 250 MG/5 ML SOLN	$0.08761	per ML	23 Sep 2026
US NADAC	GABAPENTIN 250 MG/5 ML SOLN	$0.1712	per ML	18 Feb 2026
US NADAC	GABAPENTIN 300 MG CAPSULE	$0.03142	per EA	23 Sep 2026
US NADAC	GABAPENTIN 400 MG CAPSULE	$0.04222	per EA	23 Sep 2026
US NADAC	GABAPENTIN 600 MG TABLET	$0.06398	per EA	23 Sep 2026
US NADAC	GABAPENTIN 800 MG TABLET	$0.08829	per EA	23 Sep 2026
US NADAC	GABAPENTIN ER 300 MG TABLET	$0.63846	per EA	23 Sep 2026
US NADAC	GABAPENTIN ER 600 MG TABLET	$1.02497	per EA	23 Sep 2026
US NADAC	GRALISE ER 300 MG TABLET	$10.18511	per EA	23 Sep 2026
US NADAC	GRALISE ER 450 MG TABLET	$10.14274	per EA	17 Dec 2025
US NADAC	GRALISE ER 600 MG TABLET	$10.15306	per EA	23 Sep 2026
NHS Drug Tariff	Gabapentin 100mg capsules	£1.28	100 capsule	1 Oct 2026
NHS Drug Tariff	Gabapentin 300mg capsules	£1.87	100 capsule	1 Oct 2026
NHS Drug Tariff	Gabapentin 400mg capsules	£2.03	100 capsule	1 Oct 2026
NHS Drug Tariff	Gabapentin 50mg/ml oral solution sugar free	£12.55	150 ml	1 Oct 2026
NHS Drug Tariff	Gabapentin 600mg tablets	£4.03	100 tablet	1 Oct 2026
NHS Drug Tariff	Gabapentin 800mg tablets	£8.35	100 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 25 Apr 2025 GRALISE — 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 NEURONTIN — 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 NEURONTIN — 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 NEURONTIN — 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 17 Jan 2019 PRAC signal: Dysphagia
Action for MAH: update of the product information: Yes
EMA PRAC 6 Sep 2018 PRAC signal: Dysphagia
Action for MAH: update of the product information: No
MHRA 26 Oct 2017 Gabapentin (Neurontin): risk of severe respiratory depression
Gabapentin has been associated with a rare risk of severe respiratory depression even without concomitant opioid medicines. Patients with compromised respiratory function, respiratory or neurological disease, renal impairment, concomitant use of central nervous system (CNS) depressants, and elderly people might be at higher risk of experiencing severe respiratory depression. Dose adjustments might be necessary in these patients.
EMA PRAC 9 Jun 2017 PRAC signal: Respiratory depression without concomitant opioid use
Action for MAH: update of the product information: Yes
EMA PRAC 12 Jan 2017 PRAC signal: Respiratory depression without concomitant opioid use
Action for MAH: update of the product information: No
EMA PRAC 10 Oct 2013 PRAC signal: Hypoglycaemia
Action for MAH: update of the product information: No

All safety entries for gabapentin →

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.