Pyridoxine
Berocca Pn, Bonjesta, Diclegis, Infuvite, M.v.c. 9+, M.v.i, M.v.i. Lyophilized, Mvc, Pyridoxine, Tpn, Vitaped (pyridoxine) is a small molecule pharmaceutical. Pyridoxine was first approved as Bendectin on 1982-01-01. It is used to treat seizures and vitamin b 6 deficiency in the USA.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Combinations
Bonjesta, Diclegis, Infuvite (generic drugs available since 1982-01-01, discontinued: Bendectin, Berocca pn, M.v.c. 9+, M.v.i., M.v.i. lyophilized, Mvc, Tpn, Vitaped)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Alpha-tocopherol acetate
+
Ascorbic acid
+
Biotin
+
Cholecalciferol
+
Cyanocobalamin
+
Dexpanthenol
+
Folic acid
+
Niacinamide
+
Pyridoxine hydrochloride
+
Riboflavin 5'-phosphate sodium
+
Thiamine hydrochloride
+
Vitamin a palmitate
+
Vitamin k
Ascorbic acid
+
Biotin
+
Cholecalciferol
+
Cyanocobalamin
+
Dexpanthenol
+
Folic acid
+
Niacinamide
+
Pyridoxine
+
Riboflavin
+
Thiamine
+
Tocopherol acetate
+
Vitamin a
+
Vitamin k
Ascorbic acid
+
Biotin
+
Cyanocobalamin
+
Dexpanthenol
+
Ergocalciferol
+
Folic acid
+
Niacinamide
+
Phytonadione
+
Pyridoxine hydrochloride
+
Riboflavin 5'-phosphate sodium
+
Thiamine hydrochloride
+
Vitamin a
+
Vitamin e
Ascorbic acid
+
Biotin
+
Cyanocobalamin
+
Dexpanthenol
+
Ergocalciferol
+
Folic acid
+
Niacinamide
+
Pyridoxine
+
Riboflavin 5'-phosphate sodium
+
Thiamine
+
Vitamin a
+
Vitamin e
Ascorbic acid
+
Biotin
+
Cyanocobalamin
+
Dexpanthenol
+
Ergocalciferol
+
Folic acid
+
Niacinamide
+
Pyridoxine hydrochloride
+
Riboflavin
+
Thiamine hydrochloride
+
Vitamin a
+
Vitamin e
Ascorbic acid
+
Biotin
+
Cyanocobalamin
+
Dexpanthenol
+
Ergocalciferol
+
Folic acid
+
Niacinamide
+
Pyridoxine hydrochloride
+
Riboflavin 5'-phosphate sodium
+
Thiamine hydrochloride
+
Vitamin a
+
Vitamin e
Ascorbic acid
+
Biotin
+
Cyanocobalamin
+
Dexpanthenol
+
Ergocalciferol
+
Folic acid
+
Niacinamide
+
Pyridoxine hydrochloride
+
Riboflavin 5'-phosphate sodium
+
Thiamine hydrochloride
+
Vitamin a
+
Vitamin e
+
Vitamin k
Ascorbic acid
+
Biotin
+
Cyanocobalamin
+
Dexpanthenol
+
Ergocalciferol
+
Folic acid
+
Niacinamide
+
Pyridoxine hydrochloride
+
Riboflavin 5'-phosphate sodium
+
Thiamine hydrochloride
+
Vitamin a palmitate
+
Vitamin e
Ascorbic acid
+
Biotin
+
Cyanocobalamin
+
Ergocalciferol
+
Folic acid
+
Niacinamide
+
Pantothenic acid
+
Phytonadione
+
Pyridoxine
+
Riboflavin
+
Thiamine
+
Vitamin a palmitate
+
Vitamin e
Doxylamine succinate
+
Pyridoxine hydrochloride
Niacinamide
+
Pyridoxine hydrochloride
+
Tyrosine
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| TPN | International Minerals | N-008378 DISCN | 1982-01-01 | 1 products |
Hide discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| adult infuvite multiple vitamins | New Drug Application | 2019-05-14 |
| adult infuvite multiple vitamins for infusion pharmacy bulk | New Drug Application | 2013-01-01 |
| animi-3 | unapproved drug other | 2013-02-06 |
| animi-3 with vitamin d | unapproved drug other | 2011-05-23 |
| b-plex 100 | unapproved drug other | 2020-12-04 |
| bacmin | unapproved drug other | 2014-05-02 |
| bal-care dha | unapproved drug other | 2012-05-01 |
| bal-care dha essential | unapproved drug other | 2012-05-01 |
| bonjesta | New Drug Application | 2023-07-07 |
| bp vit 3 | unapproved drug other | 2023-10-11 |
Show 99 more
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| seizures | HP_0007359 | D012640 | G40.4 |
| vitamin b 6 deficiency | — | D026681 | E53.1 |
Agency Specific
FDA
EMA
No data
ATC Codes
A: Alimentary tract and metabolism drugs
— A11: Vitamins
— A11H: Other plain vitamin preparations in atc
— A11HA: Other plain vitamin preparations in atc
— A11HA02: Pyridoxine (vit b6)
J: Antiinfectives for systemic use
— J04: Antimycobacterials
— J04A: Drugs for treatment of tuberculosis
— J04AM: Combinations of drugs for treatment of tuberculosis
— J04AM08: Isoniazid, sulfamethoxazole, trimethoprim and pyridoxine
HCPCS
Code | Description |
|---|---|
| J3415 | Injection, pyridoxine hcl, 100 mg |
Clinical
Clinical Trials
669 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | 2 | 9 | 10 | 3 | 7 | 29 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 1 | 2 | 8 | 3 | 10 | 24 |
| Anemia | D000740 | HP_0001903 | D64.9 | — | 2 | 6 | 1 | 13 | 21 |
| Obesity | D009765 | EFO_0001073 | E66.9 | 1 | — | — | 2 | 14 | 17 |
| Vitamin d deficiency | D014808 | EFO_0003762 | E55 | 1 | 2 | 1 | 2 | 9 | 13 |
| Cardiovascular diseases | D002318 | HP_0001626 | — | 1 | 4 | 1 | 4 | 3 | 12 |
| Covid-19 | D000086382 | — | U07.1 | 2 | 1 | 3 | 1 | 6 | 12 |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | 1 | — | 3 | 3 | 5 | 12 |
| Aging | D000375 | GO_0007568 | R41.81 | — | — | — | 2 | 9 | 11 |
| Iron-deficiency anemia | D018798 | HP_0001891 | D50 | — | — | 2 | 2 | 6 | 10 |
Show 65 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 6 | 4 | 1 | — | 12 | 23 |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | — | 2 | 1 | — | 11 | 13 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | 4 | 3 | — | 4 | 12 |
| Hiv | D006678 | — | O98.7 | 2 | 3 | 3 | — | 3 | 10 |
| Colorectal neoplasms | D015179 | — | — | 1 | 3 | 3 | — | 2 | 7 |
| Hyperhomocysteinemia | D020138 | — | — | — | 1 | 2 | — | 4 | 7 |
| Diarrhea | D003967 | HP_0002014 | R19.7 | — | — | 1 | — | 5 | 6 |
| Prostatic neoplasms | D011471 | — | C61 | — | — | 1 | — | 4 | 5 |
| Oxidative stress | D018384 | EFO_1001905 | — | — | 2 | 1 | — | 3 | 5 |
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | — | 2 | 1 | — | 1 | 4 |
Show 70 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypertension | D006973 | EFO_0000537 | I10 | 1 | 1 | — | — | 4 | 6 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | — | 1 | — | — | 4 | 5 |
| Autism spectrum disorder | D000067877 | HP_0000729 | F84.0 | — | 2 | — | — | 3 | 5 |
| Chronic pain | D059350 | HP_0012532 | — | — | 1 | — | — | 4 | 5 |
| Lymphoma | D008223 | — | C85.9 | 3 | 4 | — | — | — | 4 |
| Chronic fatigue syndrome | D015673 | EFO_0004540 | G93.31 | — | 2 | — | — | 2 | 4 |
| Traumatic brain injuries | D000070642 | — | S06 | — | 2 | — | — | 2 | 4 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | — | 1 | — | — | 2 | 3 |
| Psoriasis | D011565 | EFO_0000676 | L40 | 1 | 1 | — | — | 1 | 2 |
| Respiratory distress syndrome | D012128 | EFO_1000637 | J80 | 1 | 1 | — | — | 1 | 2 |
Show 34 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Depression | D003863 | — | F33.9 | 1 | — | — | — | 3 | 4 |
| Hip fractures | D006620 | EFO_0003964 | S72.00 | 1 | — | — | — | 2 | 3 |
| Birth weight | D001724 | EFO_0004344 | — | 1 | — | — | — | 1 | 2 |
| Heart rate | D006339 | EFO_0004326 | — | 1 | — | — | — | — | 1 |
| Biological availability | D001682 | — | — | 1 | — | — | — | — | 1 |
| Triple negative breast neoplasms | D064726 | — | — | 1 | — | — | — | — | 1 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 1 | — | — | — | — | 1 |
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | — | 1 | — | — | — | — | 1 |
| Burns | D002056 | — | T30.0 | 1 | — | — | — | — | 1 |
| Prostatic intraepithelial neoplasia | D019048 | — | N42.31 | 1 | — | — | — | — | 1 |
Show 2 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Weight loss | D015431 | HP_0001824 | — | — | — | — | — | 6 | 6 |
| Iron deficiencies | D000090463 | — | E61.1 | — | — | — | — | 5 | 5 |
| Anxiety | D001007 | EFO_0005230 | F41.1 | — | — | — | — | 4 | 4 |
| Growth disorders | D006130 | — | — | — | — | — | — | 4 | 4 |
| Cognitive dysfunction | D060825 | HP_0001268 | G31.84 | — | — | — | — | 4 | 4 |
| Diet therapy | D004035 | — | — | — | — | — | — | 3 | 3 |
| Aggression | D000374 | EFO_0003015 | — | — | — | — | — | 3 | 3 |
| Hypercholesterolemia | D006937 | HP_0003124 | — | — | — | — | — | 3 | 3 |
| Metabolism | D008660 | GO_0008152 | — | — | — | — | — | 3 | 3 |
| Healthy diet | D000072001 | — | — | — | — | — | — | 3 | 3 |
Show 133 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Pyridoxine |
| INN | pyridoxine |
| Description | Pyridoxine is a hydroxymethylpyridine with hydroxymethyl groups at positions 4 and 5, a hydroxy group at position 3 and a methyl group at position 2. The 4-methanol form of vitamin B6, it is converted intoto pyridoxal phosphate which is a coenzyme for synthesis of amino acids, neurotransmitters, sphingolipids and aminolevulinic acid. It has a role as a cofactor, a human metabolite, a Saccharomyces cerevisiae metabolite, an Escherichia coli metabolite and a mouse metabolite. It is a monohydroxypyridine, a vitamin B6, a member of methylpyridines and a hydroxymethylpyridine. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | Cc1ncc(CO)c(CO)c1O |
Identifiers
| PDB | — |
| CAS-ID | 65-23-6 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1364 |
| ChEBI ID | 16709 |
| PubChem CID | 1054 |
| DrugBank | DB00165 |
| UNII ID | KV2JZ1BI6Z (ChemIDplus, GSRS) |
Target
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Variants
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Financial
Revenue by drug
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Estimated US medical usage
Pyridoxine
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Doxylamine
Total medical expenditures per year (USD, in millions)
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Pyridoxine
Total medical expenditures per year (USD, in millions)
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Tabular view
Trends
PubMed Central
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Additional graphs summarizing 38,698 documents
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Safety
Black-box Warning
Black-box warning for: Citranatal, Citranatal 90 dha, Citranatal assure, Citranatal b-calm, Citranatal dha, Citranatal essence, Citranatal harmony, Citranatal harmony 2.1, Citranatal harmony 3.0, Citranatal medley, Citranatal rx, Healthy mamabe well rounded, Marnatal f, Moms choice rx, Natafort, Neonatal complete, Neonatal dha, Neonatal19, Nestabs, Nestabs dha, Nestabs one, O-cal prenatal vitamin, Pnv prenatal plus multivitamin, Pnv prenatal vitamin, Pnv-dha, Pnv-omega, Pnv-select, Pr natal 400, Pr natal 400 ec, Pr natal 430, Pr natal 430 ec, Pre-tabs dha, Prenaissance, Prenaissance plus, Prenata, Prenatal plus multivitamin plus dha minicaps, Prenate am, Prenate dha, Prenate elite, Prenate enhance, Prenate essential, Prenate mini, Prenate pixie, Prenate restore, Select ob, Select-ob plus dha, Tristart dha, Vitafol, Vitafol fe plus, Vitafol ob, Vitafol-ob plus dha
Adverse Events
Top Adverse Reactions
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3,365 adverse events reported
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