Quick answers
- What is Pyridoxine hci used for?
- The FDA-approved label (Pyridoxine Hydrochloride, Fresenius Kabi USA, LLC, October 15, 2024) says: “Pyridoxine Hydrochloride Injection is effective for the treatment of pyridoxine deficiency as seen in the following: Inadequate dietary intake. Drug-induced deficiency, as from isoniazid (INH) or oral contraceptives. Inborn errors of metabolism, e.g., vitamin B 6 dependent convulsions or vitamin B 6 responsive anemia. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the side effects of Pyridoxine hci?
- The “Adverse Reactions” section of the FDA label (Pyridoxine Hydrochloride, Fresenius Kabi USA, LLC, October 15, 2024) begins: “To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Paresthesia, somnolence, and low serum folic acid levels have been reported.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the drug interactions of Pyridoxine hci?
- The “Drug Interactions” section of the FDA label (Pyridoxine Hydrochloride, Fresenius Kabi USA, LLC, October 15, 2024) begins: “Pyridoxine supplements should not be given to patients receiving levodopa, because the action of the latter drug is antagonized by pyridoxine. However, this vitamin may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Pyridoxine hci have a boxed warning?
- No. None of the 2 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Pyridoxine hci?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Pyridoxine hci been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Pyridoxine hci?
- 2 companies list prescription products of Pyridoxine hci in the FDA NDC Directory, including HF Acquisition Co LLC, DBA HealthFirst and Fresenius Kabi USA, LLC.
What Pyridoxine hci is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Pyridoxine Hydrochloride Injection is effective for the treatment of pyridoxine deficiency as seen in the following: Inadequate dietary intake. Drug-induced deficiency, as from isoniazid (INH) or oral contraceptives. Inborn errors of metabolism, e.g., vitamin B 6 dependent convulsions or vitamin B 6 responsive anemia. …
— FDA label: Pyridoxine Hydrochloride, Fresenius Kabi USA, LLC, effective October 15, 2024. Read the full label on DailyMed →
Label quoted: the one for the most common form (injection, solution, intramuscular), Pyridoxine Hydrochloride, Fresenius Kabi USA, LLC; it covers 1 product in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.
The FDA has 2 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 2 FDA labels for this medicine have a boxed warning.
Pyridoxine hci side effects
Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.
To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Paresthesia, somnolence, and low serum folic acid levels have been reported.
— FDA label: Pyridoxine Hydrochloride, Fresenius Kabi USA, LLC, effective October 15, 2024. Read the full label on DailyMed →
Pyridoxine hci drug interactions
Quoted from the “Drug Interactions” section of the FDA-approved label. Tell your pharmacist about every medicine, vitamin and herbal product you take.
Pyridoxine supplements should not be given to patients receiving levodopa, because the action of the latter drug is antagonized by pyridoxine. However, this vitamin may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa.
— FDA label: Pyridoxine Hydrochloride, Fresenius Kabi USA, LLC, effective October 15, 2024. Read the full label on DailyMed →
Pyridoxine hci dosage
Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.
Pyridoxine Hydrochloride Injection may be administered intramuscularly or intravenously. In cases of dietary deficiency, the dosage is 10 to 20 mg daily for 3 weeks. Follow-up treatment is recommended daily for several weeks with an oral therapeutic multivitamin preparation containing 2 to 5 mg pyridoxine. Poor dietary habits should be corrected, and an adequate, well balanced diet should be prescribed.
Read more of this section
The vitamin B 6 dependency syndrome may require a therapeutic dosage of as much as 600 mg a day and a daily intake of 30 mg for life. In deficiencies due to INH, the dosage is 100 mg daily for 3 weeks followed by a 30 mg maintenance dose daily. In poisoning caused by ingestion of more than 10 g of INH, an equal amount of pyridoxine should be given — 4 g intravenously followed by 1 g intramuscularly every 30 minutes. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
— FDA label: Pyridoxine Hydrochloride, Fresenius Kabi USA, LLC, effective October 15, 2024. Read the full label on DailyMed →
Pyridoxine hci in pregnancy
Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a pregnancy.
Pregnancy Category A —The requirement for pyridoxine appears to be increased during pregnancy. Pyridoxine is sometimes of value in the treatment of nausea and vomiting of pregnancy.
— FDA label: Pyridoxine Hydrochloride, Fresenius Kabi USA, LLC, effective October 15, 2024. Read the full label on DailyMed →
Pyridoxine hci and breastfeeding
Quoted from the nursing mothers / lactation part of the FDA-approved label.
The need for pyridoxine is increased during lactation. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when pyridoxine hydrochloride is administered to a nursing woman.
— FDA label: Pyridoxine Hydrochloride, Fresenius Kabi USA, LLC, effective October 15, 2024. Read the full label on DailyMed →
When Pyridoxine hci should not be used
Quoted from the “Contraindications” section of the FDA-approved label.
A history of sensitivity to pyridoxine or to any of the ingredients in Pyridoxine Hydrochloride Injection, USP is a contraindication.
— FDA label: Pyridoxine Hydrochloride, Fresenius Kabi USA, LLC, effective October 15, 2024. Read the full label on DailyMed →
Pyridoxine hci overdose
Quoted from the “Overdosage” section of the FDA-approved label. If someone may have taken too much, call Poison Help at 1-800-222-1222 (or 911 in an emergency).
Pyridoxine given to animals in amounts of 3 to 4 g/kg of body weight produces convulsions and death. In man, a dose of 25 mg/kg of body weight is well tolerated.
— FDA label: Pyridoxine Hydrochloride, Fresenius Kabi USA, LLC, effective October 15, 2024. Read the full label on DailyMed →
Forms and how it is given
| Dosage forms | Injection, solution |
|---|---|
| Route | Intramuscular · Intravenous |
| Prescription products | 2 in the FDA NDC Directory |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- HF Acquisition Co LLC, DBA HealthFirst1 product
- Fresenius Kabi USA, LLC1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (1)
- ANDA080618Fresenius Kabi USA · August 14, 1972
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 312736 |
|---|---|
| SPL set ID of the quoted label | a56d11c0-b033-4201-85ff-fc710506481a |
| FDA labels (SPL) | 2 |
| FDA applications | 1 ANDA |
| Active ingredients (FDA) | PYRIDOXINE |
Next steps
- Find a pharmacy near youAsk which price applies to you and whether your product is affected by a recall
- Latest FDA drug recallsAll medicines, newest first
- Pyridoxine HciBrand page: products, maker and price
- HF Acquisition Co LLC, DBA HealthFirstMaker or distributor
- Fresenius Kabi USA, LLCMaker or distributor
- All prescription drugs A to ZSearch by generic, brand or Spanish name
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Pyridoxine Hydrochloride, Fresenius Kabi USA, LLC, effective October 15, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →