pharmacopeia
GET
/api/v1/drug/voriconazole
2D structure
(2R,3S)-2-(2,4-difluorophenyl)-3-(5-fluoropyrimidin-4-yl)-1-(1,2,4-triazol-1-yl)butan-2-ol
SMILES C[C@@H](C1=NC=NC=C1F)[C@](CN2C=NC=N2)(C3=C(C=C(C=C3)F)F)O
InChIKey BCEHBSKCWLPMDN-MGPLVRAMSA-N

Mechanism of action

Sourced from openFDA

Voriconazole is an antifungal drug [see Microbiology (12.4) ].

14-alpha DemethylaseCytochrome P450 2C19Cytochrome P450 2C9Cytochrome P450 3A4

Indications

Sourced from openFDA
  • VFEND is an azole antifungal indicated for the treatment of adults and pediatric patients 2 years of age and older with: • Invasive aspergillosis ( 1.1 ) • Candidemia in non-neutropenics and other deep tissue Candida infections ( 1.2 ) • Esophageal candidiasis ( 1.3 ) • Serious fungal infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani , in patients intolerant of, or refractory to, other therapy ( 1.4 ) 1.1 Invasive Aspergillosis VFEND is indicated in adults and pediatric patients (2 years of age and older) for the treatment of invasive aspergillosis (IA). In clinical trials, the majority of isolates recovered were Aspergillus fumigatus .ICD-10: B37.9

Contraindications

Sourced from openFDA
  • • VFEND is contraindicated in patients with known hypersensitivity to voriconazole or its excipients [see Warnings and Precautions (5.5) and Adverse Reactions (6.1, 6.2) ] . There is no information regarding cross-sensitivity between VFEND and other azole antifungal agents.contraindicated

Dosage & administration

Sourced from openFDA

• Dosage in Adults ( 2.3 ) Infection Loading Dose Maintenance Dose Intravenous infusion Intravenous infusion Oral tablets Oral suspension Invasive Aspergillosis 6 mg/kg every 12 hours for the first 24 hours 4 mg/kg every 12 hours 200 mg every 12 hours 5 mL every 12 hours Candidemia in nonneutropenics and other deep tissue Candida infections 3–4 mg/kg every 12 hours 200 mg every 12 hours 5 mL every 12 hours Scedosporiosis and Fusariosis 4 mg/kg every 12 hours 200 mg every 12 hours 5 mL every 12 hours Esophageal Candidiasis Not Evaluated Not Evaluated 200 mg every 12 hours 5 mL every 12 hours o Adult patients weighing less than 40 kg: oral maintenance dose 100 mg or 150 mg every 12 hours o Hepatic Impairment : Use half the maintenance dose in adult patients with mild to moderate hepatic impairment (Child-Pugh Class A and B) ( 2.5 ) o Renal Impairment : Avoid intravenous administration in adult patients with moderate to severe renal impairment (creatinine clearance <50 mL/min) ( 2.6 ) • Dosage in Pediatric Patients 2 years of age and older ( 2.4 ) o For pediatric patients 2 to less than 12 years of age and 12 to 14 years of age weighing less than 50 kg see Table below.

Warnings & precautions

Sourced from openFDA

• Hepatic Toxicity : Serious hepatic reactions reported. Evaluate liver function tests at start of and during VFEND therapy ( 5.1 ) • Arrhythmias and QT Prolongation : Correct potassium, magnesium, and calcium prior to use; caution patients with proarrhythmic conditions ( 5.2 ) • Infusion Related Reactions (including anaphylaxis) : Stop the infusion ( 5.3 ) • Visual Disturbances (including optic neuritis and papilledema): Monitor visual function if treatment continues beyond 28 days ( 5.4 ) • Severe Cutaneous Adverse Reactions : Discontinue for exfoliative cutaneous reactions ( 5.5 ) • Photosensitivity : Avoid sunlight due to risk of photosensitivity ( 5.6 ) • Adrenal Dysfunction : Carefully monitor patients receiving VFEND and corticosteroids (via all routes of administration) for adrenal dysfunction both during and after VFEND treatment. Instruct patients to seek immediate medical care if they develop signs and symptoms of Cushing's syndrome or adrenal insufficiency ( 5.8 ) • Embryo-Fetal Toxicity : Voriconazole can cause fetal harm when administered to a pregnant woman. Inform pregnant patients of the potential hazard to the fetus. Advise females of reproductive potential to use effective contraception during treatment with VFEND ( 5.9 , 8.1 , 8.3 ) • Skeletal Adverse Reactions : Fluorosis and periostitis with long-term voriconazole therapy.

Adverse reactions

Sourced from openFDA

The following serious adverse reactions are described elsewhere in the labeling: Hepatic Toxicity [see Warnings and Precautions (5.1) ] Arrhythmias and QT Prolongation [see Warnings and Precautions (5.2) ] Infusion Related Reactions [see Warnings and Precautions (5.3) ] Visual Disturbances [see Warnings and Precautions (5.4) ] Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.5) ] Photosensitivity [see Warnings and Precautions (5.6) ] Renal Toxicity [see Warnings and Precautions (5.7) ] • Adult Patients : The most common adverse reactions (incidence ≥2%) were visual disturbances, fever, nausea, rash, vomiting, chills, headache, liver function test abnormal, tachycardia, hallucinations ( 6 ) • Pediatric Patients : The most common adverse reactions (incidence ≥5%) were visual disturbances, pyrexia, vomiting, epistaxis, nausea, rash, abdominal pain, diarrhea, hypertension, hypokalemia, cough, headache, thrombocytopenia, ALT abnormal, hypotension, peripheral edema, hyperglycemia, tachycardia, dyspnea, hypocalcemia, hypophosphatemia, LFT abnormal, mucosal inflammation, photophobia, abdominal distention, constipation, dizziness, hallucinations, hemoptysis, hypoalbuminemia, hypomagnesemia, renal impairment, upper respiratory tract infection ( 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 .

Use in specific populations

Sourced from openFDA

• Pediatrics : Safety and effectiveness in patients younger than 2 years has not been established ( 8.4 ) 8.1 Pregnancy Risk Summary Voriconazole can cause fetal harm when administered to a pregnant woman. There are no available data on the use of VFEND in pregnant women. In animal reproduction studies, oral voriconazole was associated with fetal malformations in rats and fetal toxicity in rabbits. Cleft palates and hydronephrosis/hydroureter were observed in rat pups exposed to voriconazole during organogenesis at and above 10 mg/kg (0.3 times the RMD of 200 mg every 12 hours based on body surface area comparisons). In rabbits, embryomortality, reduced fetal weight and increased incidence of skeletal variations, cervical ribs and extrasternal ossification sites were observed in pups when pregnant rabbits were orally dosed at 100 mg/kg (6 times the RMD based on body surface area comparisons) during organogenesis. Rats exposed to voriconazole from implantation to weaning experienced increased gestational length and dystocia, which were associated with increased perinatal pup mortality at the 10 mg/kg dose [see Data ] . If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, inform the patient of the potential hazard to the fetus [see Warnings and Precautions (5.9) ] .

Pharmacokinetics

Sourced from openFDA
Metabolism
The pharmacokinetics of voriconazole have been characterized in healthy subjects, special populations and patients. The pharmacokinetics of voriconazole are non-linear due to saturation of its metabolism.

Overdosage

Sourced from openFDA

In clinical trials, there were three cases of accidental overdose. All occurred in pediatric patients who received up to five times the recommended intravenous dose of voriconazole. A single adverse reaction of photophobia of 10 minutes duration was reported. There is no known antidote to voriconazole. Voriconazole is hemodialyzed with clearance of 121 mL/min. The intravenous vehicle, SBECD, is hemodialyzed with clearance of 55 mL/min. In an overdose, hemodialysis may assist in the removal of voriconazole and SBECD from the body.

Approval history

Sourced from openFDA
  • May 24, 2002NDANDA021267Pf Prism Cv
  • May 24, 2002NDANDA021266Pf Prism Cv
  • Dec 19, 2003NDANDA021630Pf Prism Cv
  • Apr 22, 2010ANDAANDA090547Mylan Pharms Inc
  • Dec 12, 2011ANDAANDA200265Sandoz Inc
  • May 30, 2012ANDAANDA090862Sandoz Inc
  • Sep 2, 2015ANDAANDA203503Glenmark Pharms Ltd
  • Mar 9, 2017NDANDA208562Hikma

FDA shortages

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Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

  • Vfend, Injection, 10 mg/1 mL (NDC 0049-3190-01)To be discontinued
    Sponsor: Pfizer Inc.
    Updated
  • Vfend, Tablet, 50 mg (NDC 0049-3170-30)To be discontinued
    Sponsor: Pfizer Inc.
    Updated

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.
29,783 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. 1Drug Ineffective4,17714%
  2. 2Off Label Use2,4008.1%
  3. 3Drug Interaction2,3407.9%
  4. 4Death1,4654.9%
  5. 5Pyrexia1,4284.8%
  6. 6Pneumonia1,3354.5%
  7. 7Condition Aggravated1,1133.7%
  8. 8Bronchopulmonary Aspergillosis1,0383.5%
  9. 9Febrile Neutropenia8953.0%
  10. 10Aspergillus Infection8853.0%
  11. 11Respiratory Failure8402.8%
  12. 12Nausea7682.6%
  13. 13Diarrhoea7652.6%
  14. 14Dyspnoea7392.5%
  15. 15Product Use In Unapproved Indication7312.5%

Literature

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Recent PubMed references pinned to Voriconazole 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 209 ClinicalTrials.gov registrations naming Voriconazole as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Pharmacogenomics

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CPIC-curated drug–gene pairs for Voriconazole. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

Frequently asked questions

How does Voriconazole work?
Voriconazole is an antifungal drug [see Microbiology (12.4) ].
What is Voriconazole used for?
According to FDA labeling, Voriconazole carries indications including: VFEND is an azole antifungal indicated for the treatment of adults and pediatric patients 2 years of age and older with: • Invasive aspergillosis ( 1.1 ) • Candidemia in non-neutropenics and other deep tissue Candida infections ( 1.2 ) • Esophageal candidiasis ( 1.3 ) • Serious fungal infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani , in patients intolerant of, or refractory to, other therapy ( 1.4 ) 1.1 Invasive Aspergillosis VFEND is indicated in adults and pediatric patients (2 years of age and older) for the treatment of invasive aspergillosis (IA). In clinical trials, the majority of isolates recovered were Aspergillus fumigatus .. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Voriconazole?
Voriconazole is classified as Triazole and tetrazole derivatives, Azole Antifungal, 14-alpha Demethylase Inhibitors, Cytochrome P450 2C19 Inhibitors, Cytochrome P450 2C9 Inhibitors, Cytochrome P450 3A4 Inhibitors, Decreased Cell Membrane Integrity, Decreased Cell Membrane Synthesis & Repair.
What are the brand names for Voriconazole?
Voriconazole is marketed under brand names including Vfend.
What are the contraindications for Voriconazole?
Voriconazole labeling lists contraindications including: • VFEND is contraindicated in patients with known hypersensitivity to voriconazole or its excipients [see Warnings and Precautions (5.5) and Adverse Reactions (6.1, 6.2) ] . There is no information regarding cross-sensitivity between VFEND and other azole antifungal agents.. Always consult the full prescribing information and a clinician.
Note. Data for voriconazole 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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