What the label lists and what reports show
Phytonadione side effects
Phytonadione's FDA label: “Most common adverse reactions are cyanosis, diaphoresis, dizziness, dysgeusia, dyspnea, flushing, hypotension and tachycardia.” FAERS holds 8,435 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is nausea (679 reports).
- Generic listed
- Boxed warning
Check it at the source: the phytonadione FDA label on DailyMed (effective August 9, 2026, Hospira, Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost common adverse reactions are cyanosis, diaphoresis, dizziness, dysgeusia, dyspnea, flushing, hypotension and tachycardia.
From the label: adverse reactions, continuedThe following serious adverse reactions are described elsewhere in the labeling: • Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] • Cutaneous Reactions [see Warnings and Precautions (5.3) ] Most common adverse reactions are cyanosis, diaphoresis, dizziness, dysgeusia, dyspnea, flushing, hypotension and tachycardia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1‑800‑438‑1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of Vitamin K 1 Injection. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiac Disorders: Tachycardia, hypotension. General Disorders and Administration Site Conditions: Generalized flushing; pain, swelling, and tenderness at injection site. Hepatobiliary Disorders: Hyperbilirubinemia. Immune System Disorders: Fatal hypersensitivity reactions, anaphylactic reactions. …
Source: FDA drug label, Hospira, Inc., effective August 9, 2026 (SPL set e8808230-2c44-44c6-8cab-8f29b6b34051), via openFDA; the full label on DailyMed
What do FAERS reports show?
8,435 reports list phytonadione among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,581 are coded as a death and 3,908 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 1 is named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Phytonadione: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions