PHYTONADIONE

N/A

Manufactured by Hospira, Inc.

21,707 FDA adverse event reports analyzed

Last updated: 2026-04-14

About PHYTONADIONE

PHYTONADIONE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Hospira, Inc.. The most commonly reported adverse reactions for PHYTONADIONE include OFF LABEL USE, NAUSEA, VOMITING, FATIGUE, DYSPNOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for PHYTONADIONE.

Top Adverse Reactions

OFF LABEL USE654 reports
NAUSEA630 reports
VOMITING533 reports
FATIGUE523 reports
DYSPNOEA486 reports
DRUG INEFFECTIVE485 reports
SEPSIS446 reports
DIARRHOEA436 reports
ABDOMINAL PAIN428 reports
CONSTIPATION405 reports
HEADACHE372 reports
ABDOMINAL DISTENSION368 reports
CONDITION AGGRAVATED364 reports
PYREXIA346 reports
ANAEMIA344 reports
ASCITES337 reports
GENERAL PHYSICAL HEALTH DETERIORATION314 reports
MULTIPLE ORGAN DYSFUNCTION SYNDROME313 reports
PAIN303 reports
PNEUMONIA303 reports
HYPONATRAEMIA295 reports
DEATH280 reports
STRESS278 reports
ASTHENIA276 reports
SOMNOLENCE269 reports
ARTHRALGIA267 reports
APPENDICITIS246 reports
CARDIOGENIC SHOCK240 reports
APPENDICOLITH237 reports
COUGH237 reports
DRUG HYPERSENSITIVITY230 reports
WEIGHT DECREASED225 reports
HYPOTENSION223 reports
PRODUCT USE IN UNAPPROVED INDICATION219 reports
VENTRICULAR FIBRILLATION219 reports
MALAISE214 reports
PULMONARY EMBOLISM212 reports
RASH211 reports
ACUTE KIDNEY INJURY205 reports
DIZZINESS202 reports
THROMBOCYTOPENIA199 reports
DRY MOUTH198 reports
HYPERTENSION198 reports
PAIN IN EXTREMITY187 reports
THROMBOSIS185 reports
SWELLING178 reports
INTERNATIONAL NORMALISED RATIO INCREASED174 reports
SLEEP DISORDER174 reports
DECREASED APPETITE170 reports
OEDEMA PERIPHERAL170 reports
DIABETES MELLITUS166 reports
INTENTIONAL PRODUCT MISUSE165 reports
PRURITUS163 reports
INFECTION160 reports
BLOOD CHOLESTEROL INCREASED157 reports
DRUG INTERACTION156 reports
BLOOD PHOSPHORUS INCREASED154 reports
CHRONIC OBSTRUCTIVE PULMONARY DISEASE153 reports
INSOMNIA153 reports
BACTERIAL INFECTION149 reports
PLEURAL EFFUSION149 reports
MYASTHENIA GRAVIS148 reports
FALL147 reports
INCORRECT ROUTE OF PRODUCT ADMINISTRATION147 reports
HAEMOGLOBIN DECREASED146 reports
DRUG INTOLERANCE142 reports
HYPOPHOSPHATAEMIA142 reports
NEURALGIA141 reports
PRODUCT DOSE OMISSION ISSUE140 reports
INFECTIVE PULMONARY EXACERBATION OF CYSTIC FIBROSIS139 reports
ANXIETY137 reports
FEELING ABNORMAL137 reports
TREMOR137 reports
BLOOD CREATININE INCREASED136 reports
HYPERPHOSPHATAEMIA135 reports
ASPARTATE AMINOTRANSFERASE INCREASED134 reports
BACK PAIN133 reports
ABDOMINAL PAIN UPPER132 reports
WEIGHT INCREASED131 reports
RESPIRATORY FAILURE128 reports
FOETAL EXPOSURE DURING PREGNANCY127 reports
ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED126 reports
FEBRILE NEUTROPENIA126 reports
DEHYDRATION122 reports
BLOOD URIC ACID INCREASED121 reports
PLATELET COUNT DECREASED121 reports
RENAL FAILURE119 reports
URINARY TRACT INFECTION118 reports
COVID 19117 reports
MUSCULOSKELETAL STIFFNESS117 reports
MYALGIA117 reports
COAGULOPATHY115 reports
NASOPHARYNGITIS115 reports
NEUTROPENIA114 reports
ALOPECIA113 reports
ASTHMA113 reports
EPISTAXIS113 reports
CONFUSIONAL STATE111 reports
CHEST PAIN110 reports
LOWER RESPIRATORY TRACT INFECTION107 reports

Report Outcomes

Out of 8,077 classified reports for PHYTONADIONE:

Serious 80.7%Non-Serious 19.3%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female4,012 (53.1%)
Male3,520 (46.6%)
Unknown17 (0.2%)

Reports by Age

Age 80368 reports
Age 68163 reports
Age 70142 reports
Age 66130 reports
Age 60122 reports
Age 67119 reports
Age 54117 reports
Age 69117 reports
Age 64116 reports
Age 73116 reports
Age 71115 reports
Age 65109 reports
Age 57106 reports
Age 59102 reports
Age 62101 reports
Age 61100 reports
Age 63100 reports
Age 74100 reports
Age 5897 reports
Age 7697 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with PHYTONADIONE?

This profile reflects 21,707 FDA FAERS reports that mention PHYTONADIONE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for PHYTONADIONE?

Frequently reported terms in FAERS include OFF LABEL USE, NAUSEA, VOMITING, FATIGUE, DYSPNOEA, DRUG INEFFECTIVE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures PHYTONADIONE?

Labeling and FAERS entries often list Hospira, Inc. in connection with PHYTONADIONE. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.