pharmacopeia
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/api/v1/drug/pyridoxine

Boxed warning

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Enzyme Interactions.

Indications

Sourced from openFDA
  • PNV-DHA is a multivitamin/multimineral nutritional supplement indicated for use in the dietary management of patients with nutritional deficiencies or are in need of nutritional supplementation.

Contraindications

Sourced from openFDA
  • This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.contraindicated

Dosage & administration

Sourced from openFDA

Before, during and/or after pregnancy, one softgel daily or as directed by a physician.

Warnings & precautions

Sourced from openFDA

Ingestion of more than 3 grams of omega-3 fatty acids (such as DHA) per day has been shown to have potential antithrombotic effects, including an increased bleeding time and International Normalized Ratio (INR). Administration of omega-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an inherited or acquired predisposition to bleeding.

Adverse reactions

Sourced from openFDA

Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

Approval history

Sourced from openFDA
  • Aug 14, 1972ANDAANDA080618Fresenius Kabi Usa
  • Feb 21, 2001NDANDA021265Sandoz Canada Inc
  • Apr 8, 2013NDANDA021876Duchesnay
  • Aug 19, 2016ANDAANDA205811Actavis Labs Fl Inc
  • Nov 7, 2016NDANDA209661Duchesnay
  • Dec 6, 2017ANDAANDA208518Ph Health
  • Aug 4, 2023ANDAANDA217000Bionpharma
  • Apr 9, 2026ANDAANDA210273Apotex

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
4,676 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Nausea54212%
  2. 2Off Label Use48910%
  3. 3Vomiting47610%
  4. 4Pain4309.2%
  5. 5Fatigue3738.0%
  6. 6Diarrhoea3717.9%
  7. 7Headache3537.5%
  8. 8Drug Ineffective3427.3%
  9. 9General Physical Health Deterioration3236.9%
  10. 10Abdominal Pain3206.8%
  11. 11Somnolence3146.7%
  12. 12Condition Aggravated3106.6%
  13. 13Constipation3056.5%
  14. 14Abdominal Distension2896.2%
  15. 15Dyspnoea2816.0%

Literature

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Recent PubMed references pinned to Pyridoxine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 378 ClinicalTrials.gov registrations naming Pyridoxine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Pyridoxine work?
Mechanism-of-action class: Enzyme Interactions.
What is Pyridoxine used for?
According to FDA labeling, Pyridoxine carries indications including: PNV-DHA is a multivitamin/multimineral nutritional supplement indicated for use in the dietary management of patients with nutritional deficiencies or are in need of nutritional supplementation.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Pyridoxine?
Pyridoxine is classified as Other plain vitamin preparations, Vitamin B6 Analog, Enzyme Interactions, Cellular Activity Alteration.
What are the brand names for Pyridoxine?
Pyridoxine is marketed under brand names including Animi-3 with Vitamin D, Beelith, Bonjesta, Concept OB, Dialyvite 800, Dialyvite 800 with Iron, Dialyvite 800 with Zinc, Diclegis.
What are the contraindications for Pyridoxine?
Pyridoxine labeling lists contraindications including: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.. Always consult the full prescribing information and a clinician.
Note. Data for pyridoxine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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