Is Pyridoxine registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Pyridoxine, including PYRIDOXIN TAB 40MG (40 mg, Tablet, SAR 5.35).

Is Pyridoxine approved by the US FDA?

Drugs@FDA lists 11 application product lines for Pyridoxine, including PYRIDOXINE HYDROCHLORIDE (Prescription); HEXA-BETALIN (Discontinued); PYRIDOXINE HYDROCHLORIDE (Discontinued); PYRIDOXINE HYDROCHLORIDE (Discontinued); PYRIDOXINE HYDROCHLORIDE (Discontinued).

Is Pyridoxine on the WHO Model List of Essential Medicines?

Yes — 27. Vitamins and minerals (core list): Other specified polyneuropathy; Vitamin B6 deficiency; Sideroblastic anaemia.

Are there safety signals or safety updates for Pyridoxine?

EMA PRAC: 1 entry; US FDA: 7 entries (latest 2026-05-07).

Active substance

Pyridoxine

SFDA 2
US FDA 11
Health Canada 1
NHS prices 2
WHO EML 1
Safety 8

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
PYRIDOXIN TAB 40MG	40 mg	Tablet · Oral use	20 Blister	SAR 5.35	NCE · OTC	ALPHA PHARMA INDUSTRY	Valid
PYRIDOXIN TAB 40MG	40 mg	Tablet · Oral use	1 Blister	SAR 5.35	NCE · OTC	Gulf Pharmaceutical Industries (Julphar)	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

NAUSEA AND VOMITING IN PREGNANCY; PERITONITIS, PERITONEAL DIALYSIS-RELATED PERITONITIS; RENAL AND URETERIC STONES; RENAL TRANSPLANT; TUBERCULOSIS-SUPPORTIVE CARE; WILSON'S DISEASE

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

Product	Strength	Form · route	Applicant	Status	First approved
PYRIDOXINE HYDROCHLORIDE	100MG/ML	injectable · injection	FRESENIUS KABI USA	Prescription	14 Aug 1972
HEXA-BETALIN	100MG/ML	injectable · injection	LILLY	Discontinued	22 Jun 1973
PYRIDOXINE HYDROCHLORIDE	100MG/ML	injectable · injection	BEL MAR	Discontinued	11 Dec 1973
PYRIDOXINE HYDROCHLORIDE	100MG/ML	injectable · injection	DR REDDYS	Discontinued	13 Feb 1974
PYRIDOXINE HYDROCHLORIDE	50MG/ML	injectable · injection	DELL LABS	Discontinued	18 Mar 1975
PYRIDOXINE HYDROCHLORIDE	100MG/ML	injectable · injection	DELL LABS	Discontinued	14 Aug 2012
PYRIDOXINE HYDROCHLORIDE	100MG/ML	injectable · injection	MYLAN INSTITUTIONAL	Discontinued	14 Jul 2016
PYRIDOXINE HYDROCHLORIDE	100MG/ML	injectable · injection	ELKINS SINN	Discontinued
PYRIDOXINE HYDROCHLORIDE	100MG/ML	injectable · injection	LUITPOLD	Discontinued
PYRIDOXINE HYDROCHLORIDE	100MG/ML	injectable · injection	WATSON LABS	Discontinued
PYRIDOXINE HYDROCHLORIDE	100MG/ML	injectable · injection	EPIC PHARMA LLC	Discontinued

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
PYRIDOXINE HYDROCHLORIDE INJECTION, USP	02245215	100 MG / ML	SOLUTION · INTRAVENOUS; INTRAMUSCULAR	MYLAN PHARMACEUTICALS ULC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
NHS Drug Tariff	Pyridoxine 10mg tablets	£31.96	28 tablet	1 Oct 2026
NHS Drug Tariff	Pyridoxine 50mg tablets	£4.13	28 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)

27. Vitamins and minerals · core
Other specified polyneuropathy; Vitamin B6 deficiency; Sideroblastic anaemia
Oral > Solid > tablet: 25 mg (hydrochloride); 10 mg (hydrochloride) (EMLc)

Safety signals and safety-related labeling changes

EMA PRAC 7 May 2026 PRAC signal: Miscarriage associated with in utero exposure to benzodiazepines (including fixed-dose combinations)
Action for MAH: update of the product information: No
US FDA 6 Nov 2024 INFUVITE ADULT — safety-related labeling change
Labeling sections changed: Use in Specific Populations
US FDA 6 Nov 2024 INFUVITE PEDIATRIC — safety-related labeling change
Labeling sections changed: Use in Specific Populations
US FDA 16 Dec 2020 M.V.I. ADULT — safety-related labeling change
Labeling sections changed: Contraindications; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 18 Jun 2018 BONJESTA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide
US FDA 18 Jun 2018 DICLEGIS — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 9 Nov 2017 M.V.I. ADULT (PHARMACY BULK PACKAGE) — safety-related labeling change
Labeling sections changed: Contraindications; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 9 Nov 2017 M.V.I.-12 — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for pyridoxine →

Combinations containing Pyridoxine

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.