Phytonadione: uses, dosing, side effects & brands
Phytonadione is a vitamin k sold in the U.S. under 4 brand and generic names, for drug-induced abnormalities, hypoprothrombinemias and diseases premature infant. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Vitamin K
- Treats (across its forms)
- Drug-Induced Abnormalities, Hypoprothrombinemias and Diseases Premature Infant
- Available as
- Injectable · Emulsion · Tablet
- Sold as
- 4 products — Aquamephyton, Vitamin K1 and Konakion, and others
- Prescription?
- Prescription only
- Generic available?
- Yes
- What the pharmacy pays
- about $340 for a 30-count supply — not your price
- Boxed warning
- Boxed warning
How Vitamin K1 is dosed
From the FDA label for Vitamin K1 (application ANDA087954). Other phytonadione products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Whenever possible, Vitamin K1 Injection (Phytonadione Injectable Emulsion, USP) should be given by the subcutaneous route (See BOX WARNING ). When intravenous administration is considered unavoidable, the drug should be injected very slowly, not exceeding 1 mg per minute. Protect from light at all times. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Directions for Dilution Vitamin K1 Injection may be diluted with 0.9% Sodium Chloride Injection, 5% Dextrose Injection, or 5% Dextrose and Sodium Chloride Injection. Benzyl alcohol as a preservative has been associated with toxicity in newborns. Therefore, all of the above diluents should be preservative-free (See WARNINGS ). Other diluents should not be used. When dilutions are indicated, administration should be started immediately after mixture with the diluent, and unused portions of the dilution should be discarded, as well as unused contents of the ampul. Prophylaxis of Hemorrhagic Disease of the Newborn The American Academy of Pediatrics recommends that vitamin K1 be given to the newborn. A single intramuscular dose of Vitamin K1 Injection 0.5 to 1 mg within one hour of birth is recommended. Treatment of Hemorrhagic Disease of the Newborn Empiric administration of vitamin K1 should not replace proper laboratory…
Everything below is the FDA label for Vitamin K1 (injectable, emulsion). Phytonadione is also sold as tablet, and those are different medicines to take — follow the label for the one you were prescribed.
Vitamin K1 side effects
Deaths have occurred after intravenous and intramuscular administration. (See BOX WARNING .) Transient "flushing sensations" and "peculiar" sensations of taste have been observed, as well as rare instances of dizziness, rapid and weak pulse, profuse sweating, brief hypotension, dyspnea, and cyanosis. Pain, swelling, and tenderness at the injection site may occur. The possibility of allergic sensitivity including an anaphylactoid reaction, should be kept in mind. Infrequently, usually after repeated injection, erythematous, indurated, pruritic plaques have occurred; rarely, these have progressed to scleroderma-like lesions that have persisted for long periods. In other cases, these lesions have resembled erythema perstans. Hyperbilirubinemia has been observed in the newborn following administration of phytonadione. This has occurred rarely and primarily with doses above those recommended (See PRECAUTIONS , PEDIATRIC USE).
Who shouldn’t take Vitamin K1
Hypersensitivity to any component of this medication.
Every phytonadione product we track (4)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | 70/100 | Prescription | Injectable | Generic | $340 | View → | |
| 2 | 60/100 | Prescription | Injectable | Generic | $340 | View → | |
| 3 | Not yet rated | Prescription | Injectable | Generic | $340 | View → | |
| 4 | Not yet rated | Prescription | Injectable | Generic | $340 | View → |
Combination products containing phytonadione
A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.
Phytonadione recalls
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
How long phytonadione keeps
No phytonadione label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.
Does phytonadione expire? The in-use limits and storage rules from its labelsWhat people report to the FDA about phytonadione
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 2,371 reports naming phytonadione, and the FDA flagged 92% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- sepsis327 reports
- nausea305 reports
- vomiting297 reports
- abdominal distension279 reports
- general physical health deterioration271 reports
- abdominal pain267 reports
- ascites264 reports
- hyponatraemia263 reports
Read these as a signal, not a rate. A report does not mean phytonadione caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 27, 2026.
Related calculators
Frequently asked questions
What is Vitamin K1?
Vitamin K1 (Phytonadione) is a vitamin k used to treat Drug-Induced Abnormalities, Hypoprothrombinemias, Diseases Premature Infant.
What kind of drug is phytonadione?
The FDA classifies phytonadione as a vitamin k. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take phytonadione with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run phytonadione against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is phytonadione sold under?
We track 4 phytonadione-containing products in the U.S.: Aquamephyton, Vitamin K1, Konakion and Phytonadione. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does phytonadione come in?
Across the brands we track, phytonadione is currently marketed as injectable, emulsion and tablet, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic phytonadione?
Yes. Our catalog lists 2 generic phytonadione products alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.
Has phytonadione been recalled?
The FDA's Enforcement database lists 1 recall record whose product description mentions phytonadione. The most recent: Phytonadione Injectable Emulsion (Oct 31, 2025). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.
Cite this page
- APA
- pharmaranks. (2026, July 24). Phytonadione: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/phytonadione
- MLA
- “Phytonadione: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/phytonadione.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for phytonadione on DailyMed (NIH) ↗ — including its boxed warning in full.