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Vfend

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Vfend

Vfend Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Vfend (voriconazole) is used to treat infections caused by yeast or other types of fungus. It is an antifungal medication. This medication may be available in generic form. Common side effects include nausea/vomiting, diarrhea, and headache.

Vfend is taken by mouth on an empty stomach usually twice daily, or as directed by your doctor, until the full prescribed amount is finished. The dose and duration of treatment depend on the patient's condition and response to therapy. Vfend may interact with phenytoin, clopidogrel, cyclosporine, tacrolimus, warfarin, stomach acid reducers, tranquilizers or sedatives, cholesterol-lowering medicines, vinblastine, vincristine, or vinorelbine, calcium channel blockers, or oral diabetes medicines. Tell your doctor all medications you are taking. Vfend is not recommended for use during pregnancy as it may harm a fetus. It is recommended that men and women using this medication use two effective forms of birth control (e.g., condoms and diaphragms with spermicide) while taking this medication. It is not known if this medication passes into breast milk. Breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.

Our Vfend (voriconazole) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Vfend in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • sudden behavior changes, problems with thinking or speech;
  • upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • urinating less than usual or not at all;
  • bone pain, swelling;
  • uneven heart rate, chest pain, general ill feeling; or
  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects may include:

  • vision problems such as blurred vision, eyes being more sensitive to light;
  • fever;
  • mild nausea, vomiting, or diarrhea;
  • headache; or
  • swelling in your hands, ankles, or feet.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Vfend (Voriconazole) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Vfend Overview - Patient Information: Side Effects

SIDE EFFECTS: Nausea/vomiting, diarrhea, and headache may occur. If any of these effects persist or worsen, notify your doctor promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: vision changes (e.g., blurred vision, color vision changes), sensitivity of eyes to light (photophobia), bone/muscle/joint pain, weakness, mental/mood changes, muscle stiffness/spasm, restlessness, swelling of the ankles/feet, tiredness, easy bleeding/bruising, signs of infection (e.g., fever, persistent sore throat).

Seek immediate medical attention if any of these rare but very serious side effects occur: fast/slow/irregular heartbeat, severe dizziness, fainting, change in the amount of urine, confusion, slurred speech, trouble breathing, chest/jaw/left arm pain, seizures.

Voriconazole may rarely cause serious (possibly fatal) liver problems. Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: yellowing eyes/skin, dark urine, persistent nausea/vomiting, stomach/abdominal pain.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Voriconazole can commonly cause a mild rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe allergic reaction. Therefore, seek immediate medical attention if you develop any rash.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Vfend (Voriconazole)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Vfend FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in 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.

Overview

The most frequently reported adverse events (all causalities) in the therapeutic trials were visual disturbances (18.7%), fever (5.7%), nausea (5.4%), rash (5.3%), vomiting (4.4%), chills (3.7%), headache (3.0%), liver function test increased (2.7%), tachycardia (2.4%), hallucinations (2.4%). The treatment-related adverse events which most often led to discontinuation of voriconazole therapy were elevated liver function tests, rash, and visual disturbances [see WARNINGS AND PRECAUTIONS].

Clinical Trial Experience In Adults

The data described in Table 3 reflect exposure to voriconazole in 1655 patients in the therapeutic studies. This represents a heterogeneous population, including immunocompromised patients, e.g., patients with hematological malignancy or HIV and non-neutropenic patients. This subgroup does not include healthy subjects and patients treated in the compassionate use and non-therapeutic studies. This patient population was 62% male, had a mean age of 46 years (range 11-90, including 51 patients aged 12-18 years), and was 78% White and 10% Black. Five hundred sixty one patients had a duration of voriconazole therapy of greater than 12 weeks, with 136 patients receiving voriconazole for over six months. Table 3 includes all adverse events which were reported at an incidence of ≥ 2% during voriconazole therapy in the all therapeutic studies population, studies 307/602 and 608 combined, or study 305, as well as events of concern which occurred at an incidence of < 2%.

In study 307/602, 381 patients (196 on voriconazole, 185 on amphotericin B) were treated to compare voriconazole to amphotericin B followed by other licensed antifungal therapy in the primary treatment of patients with acute invasive aspergillosis. The rate of discontinuation from voriconazole study medication due to adverse events was 21.4% (42/196 patients). In study 608, 403 patients with candidemia were treated to compare voriconazole (272 patients) to the regimen of amphotericin B followed by fluconazole (131 patients). The rate of discontinuation from voriconazole study medication due to adverse events was 19.5% out of 272 patients. Study 305 evaluated the effects of oral voriconazole (200 patients) and oral fluconazole (191 patients) in the treatment of esophageal candidiasis. The rate of discontinuation from voriconazole study medication in Study 305 due to adverse events was 7% (14/200 patients). Laboratory test abnormalities for these studies are discussed under Clinical Laboratory Values below.

Table 3: Treatment Emergent Adverse Events Rate ≥ 2% on Voriconazole or Adverse Events of Concern in All Therapeutic Studies Population, Studies 307/602-608 Combined, or Study 305. Possibly Related to Therapy or Causality Unknown†

All Therapeutic Studies Studies 307/602 and 608 (IV/ oral therapy) Study 305 (oral therapy)
Voriconazole N=1655 Voriconazole N=468 Ampho B* N=185 Ampho B→ Fluconazole N=131 Voriconazole N=200 Fluconazole N=191
N (%) N (%) N (%) N (%) N (%) N (%)
Special Senses**
Abnormal vision 310 (18.7) 63 (13.5) 1 (0.5) 0 31 (15.5) 8 (4.2)
Photophobia 37 (2.2) 8 (1.7) 0 0 5 (2.5) 2 (1.0)
Chromatopsia 20 (1.2) 2 (0.4) 0 0 2 (1.0) 0
Body as a Whole
Fever 94 (5.7) 8 (1.7) 25 (13.5) 5 (3.8) 0 0
Chills 61 (3.7) 1 (0.2) 36 (19.5) 8 (6.1) 1 (0.5) 0
Headache 49 (3.0) 9 (1.9) 8 (4.3) 1 (0.8) 0 1 (0.5)
Cardiovascular System
Tachycardia 39 (2.4) 6 (1.3) 5 (2.7) 0 0 0
Digestive System
Nausea 89 (5.4) 18 (3.8) 29 (15.7) 2 (1.5) 2 (1.0) 3 (1.6)
Vomiting 72 (4.4) 15 (3.2) 18 (9.7) 1 (0.8) 2 (1.0) 1 (0.5)
Liver function tests abnormal 45 (2.7) 15 (3.2) 4 (2.2) 1 (0.8) 6 (3.0) 2 (1.0)
Cholestatic jaundice 17 (1.0) 8 (1.7) 0 1 (0.8) 3 (1.5) 0
Metabolic and Nutritional Systems
Alkaline phosphatase increased 59 (3.6) 19 (4.1) 4 (2.2) 3 (2.3) 10 (5.0) 3 (1.6)
Hepatic enzymes increased 30 (1.8) 11 (2.4) 5 (2.7) 1 (0.8) 3 (1.5) 0
SGOT increased 31 (1.9) 9 (1.9) 0 1 (0.8) 8 (4.0) 2 (1.0)
SGPT increased 29 (1.8) 9 (1.9) 1 (0.5) 2 (1.5) 6 (3.0) 2 (1.0)
Hypokalemia 26 (1.6) 3 (0.6) 36 (19.5) 16 (12.2) 0 0
Bilirubinemia 15 (0.9) 5 (1.1) 3 (1.6) 2 (1.5) 1 (0.5) 0
Creatinine increased 4 (0.2) 0 59 (31.9) 10 (7.6) 1 (0.5) 0
Nervous System
Hallucinations 39 (2.4) 13 (2.8) 1 (0.5) 0 0 0
Skin and Appendages
Rash 88 (5.3) 20 (4.3) 7 (3.8) 1 (0.8) 3 (1.5) 1 (0.5)
Urogenital
Kidney function abnormal 10 (0.6) 6 (1.3) 40 (21.6) 9 (6.9) 1 (0.5) 1 (0.5)
Acute kidney failure 7 (0.4) 2 (0.4) 11 (5.9) 7 (5.3) 0 0
† Study 307/602: invasive aspergillosis; Study 608: candidemia; Study 305: esophageal candidiasis
* Amphotericin B followed by other licensed antifungal therapy
**See WARNINGS AND PRECAUTIONS

Visual Disturbances

Voriconazole treatment-related visual disturbances are common. In therapeutic trials, approximately 21% of patients experienced abnormal vision, color vision change and/or photophobia. Visual disturbances may be associated with higher plasma concentrations and/or doses.

There have been post-marketing reports of prolonged visual adverse events, including optic neuritis and papilledema [see WARNINGS AND PRECAUTIONS].

The mechanism of action of the visual disturbance is unknown, although the site of action is most likely to be within the retina. In a study in healthy subjects investigating the effect of 28-day treatment with voriconazole on retinal function, voriconazole caused a decrease in the electroretinogram (ERG) waveform amplitude, a decrease in the visual field, and an alteration in color perception. The ERG measures electrical currents in the retina. The effects were noted early in administration of voriconazole and continued through the course of study drug dosing. Fourteen days after end of dosing, ERG, visual fields and color perception returned to normal [see WARNINGS AND PRECAUTIONS].

Dermatological Reactions

Dermatological reactions were common in the patients treated with voriconazole. The mechanism underlying these dermatologic adverse events remains unknown.

Serious cutaneous reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme have been reported during treatment with VFEND. If a patient develops an exfoliative cutaneous reaction, VFEND should be discontinued.

In addition, VFEND has been associated with photosensitivity skin reactions. Patients should avoid strong, direct sunlight during VFEND therapy. In patients with photosensitivity skin reactions, squamous cell carcinoma of the skin and melanoma have been reported during long-term therapy. If a patient develops a skin lesion consistent with squamous cell carcinoma or melanoma, VFEND should be discontinued [see WARNINGS AND PRECAUTIONS].

Less Common Adverse Events

The following adverse events occurred in < 2% of all voriconazole-treated patients in all therapeutic studies (N=1655). This listing includes events where a causal relationship to voriconazole cannot be ruled out or those which may help the physician in managing the risks to the patients. The list does not include events included in Table 5 above and does not include every event reported in the voriconazole clinical program.

Body as a Whole: abdominal pain, abdomen enlarged, allergic reaction, anaphylactoid reaction [see WARNINGS AND PRECAUTIONS], ascites, asthenia, back pain, chest pain, cellulitis, edema, face edema, flank pain, flu syndrome, graft versus host reaction, granuloma, infection, bacterial infection, fungal infection, injection site pain, injection site infection/inflammation, mucous membrane disorder, multi-organ failure, pain, pelvic pain, peritonitis, sepsis, substernal chest pain.

Cardiovascular: atrial arrhythmia, atrial fibrillation, AV block complete, bigeminy, bradycardia, bundle branch block, cardiomegaly, cardiomyopathy, cerebral hemorrhage, cerebral ischemia, cerebrovascular accident, congestive heart failure, deep thrombophlebitis, endocarditis, extrasystoles, heart arrest, hypertension, hypotension, myocardial infarction, nodal arrhythmia, palpitation, phlebitis, postural hypotension, pulmonary embolus, QT interval prolonged, supraventricular extrasystoles, supraventricular tachycardia, syncope, thrombophlebitis, vasodilatation, ventricular arrhythmia, ventricular fibrillation, ventricular tachycardia (including torsade de pointes) [see WARNINGS AND PRECAUTIONS].

Digestive: anorexia, cheilitis, cholecystitis, cholelithiasis, constipation, diarrhea, duodenal ulcer perforation, duodenitis, dyspepsia, dysphagia, dry mouth, esophageal ulcer, esophagitis, flatulence, gastroenteritis, gastrointestinal hemorrhage, GGT/LDH elevated, gingivitis, glossitis, gum hemorrhage, gum hyperplasia, hematemesis, hepatic coma, hepatic failure, hepatitis, intestinal perforation, intestinal ulcer, jaundice, enlarged liver, melena, mouth ulceration, pancreatitis, parotid gland enlargement, periodontitis, proctitis, pseudomembranous colitis, rectal disorder, rectal hemorrhage, stomach ulcer, stomatitis, tongue edema.

Endocrine: adrenal cortex insufficiency, diabetes insipidus, hyperthyroidism, hypothyroidism.

Hemic and Lymphatic: agranulocytosis, anemia (macrocytic, megaloblastic, microcytic, normocytic), aplastic anemia, hemolytic anemia, bleeding time increased, cyanosis, DIC, ecchymosis, eosinophilia, hypervolemia, leukopenia, lymphadenopathy, lymphangitis, marrow depression, pancytopenia, petechia, purpura, enlarged spleen, thrombocytopenia, thrombotic thrombocytopenic purpura.

Metabolic and Nutritional: albuminuria, BUN increased, creatine phosphokinase increased, edema, glucose tolerance decreased, hypercalcemia, hypercholesteremia, hyperglycemia, hyperkalemia, hypermagnesemia, hypernatremia, hyperuricemia, hypocalcemia, hypoglycemia, hypomagnesemia, hyponatremia, hypophosphatemia, peripheral edema, uremia.

Musculoskeletal: arthralgia, arthritis, bone necrosis, bone pain, leg cramps, myalgia, myasthenia, myopathy, osteomalacia, osteoporosis.

Nervous System: abnormal dreams, acute brain syndrome, agitation, akathisia, amnesia, anxiety, ataxia, brain edema, coma, confusion, convulsion, delirium, dementia, depersonalization, depression, diplopia, dizziness, encephalitis, encephalopathy, euphoria, Extrapyramidal Syndrome, grand mal convulsion, Guillain-Barré syndrome, hypertonia, hypesthesia, insomnia, intracranial hypertension, libido decreased, neuralgia, neuropathy, nystagmus, oculogyric crisis, paresthesia, psychosis, somnolence, suicidal ideation, tremor, vertigo.

Respiratory System: cough increased, dyspnea, epistaxis, hemoptysis, hypoxia, lung edema, pharyngitis, pleural effusion, pneumonia, respiratory disorder, respiratory distress syndrome, respiratory tract infection, rhinitis, sinusitis, voice alteration.

Skin and Appendages: alopecia, angioedema, contact dermatitis, discoid lupus erythematosis, eczema, erythema multiforme, exfoliative dermatitis, fixed drug eruption, furunculosis, herpes simplex, maculopapular rash, melanoma, melanosis, photosensitivity skin reaction, pruritus, pseudoporphyria, psoriasis, skin discoloration, skin disorder, skin dry, Stevens-Johnson syndrome, squamous cell carcinoma, sweating, toxic epidermal necrolysis, urticaria.

Special Senses: abnormality of accommodation, blepharitis, color blindness, conjunctivitis, corneal opacity, deafness, ear pain, eye pain, eye hemorrhage, dry eyes, hypoacusis, keratitis, keratoconjunctivitis, mydriasis, night blindness, optic atrophy, optic neuritis, otitis externa, papilledema, retinal hemorrhage, retinitis, scleritis, taste loss, taste perversion, tinnitus, uveitis, visual field defect.

Urogenital: anuria, blighted ovum, creatinine clearance decreased, dysmenorrhea, dysuria, epididymitis, glycosuria, hemorrhagic cystitis, hematuria, hydronephrosis, impotence, kidney pain, kidney tubular necrosis, metrorrhagia, nephritis, nephrosis, oliguria, scrotal edema, urinary incontinence, urinary retention, urinary tract infection, uterine hemorrhage, vaginal hemorrhage.

Clinical Laboratory Values

The overall incidence of clinically significant transaminase abnormalities in all therapeutic studies was 12.4% (206/1655) of patients treated with voriconazole. Increased incidence of liver function test abnormalities may be associated with higher plasma concentrations and/or doses. The majority of abnormal liver function tests either resolved during treatment without dose adjustment or following dose adjustment, including discontinuation of therapy.

Voriconazole has been infrequently associated with cases of serious hepatic toxicity including cases of jaundice and rare cases of hepatitis and hepatic failure leading to death. Most of these patients had other serious underlying conditions.

Liver function tests should be evaluated at the start of and during the course of VFEND therapy. Patients who develop abnormal liver function tests during VFEND therapy should be monitored for the development of more severe hepatic injury. Patient management should include laboratory evaluation of hepatic function (particularly liver function tests and bilirubin). Discontinuation of VFEND must be considered if clinical signs and symptoms consistent with liver disease develop that may be attributable to VFEND [see WARNINGS AND PRECAUTIONS].

Acute renal failure has been observed in severely ill patients undergoing treatment with VFEND. Patients being treated with voriconazole are likely to be treated concomitantly with nephrotoxic medications and have concurrent conditions that may result in decreased renal function. It is recommended that patients are monitored for the development of abnormal renal function. This should include laboratory evaluation, particularly serum creatinine.

Tables 4 to 6 show the number of patients with hypokalemia and clinically significant changes in renal and liver function tests in three randomized, comparative multicenter studies. In study 305, patients with esophageal candidiasis were randomized to either oral voriconazole or oral fluconazole. In study 307/602, patients with definite or probable invasive aspergillosis were randomized to either voriconazole or amphotericin B therapy. In study 608, patients with candidemia were randomized to either voriconazole or the regimen of amphotericin B followed by fluconazole.

Table 4: Protocol 305 - Patients with Esophageal Candidiasis Clinically Significant Laboratory Test Abnormalities

Criteria* Voriconazole
n/N (%)
Fluconazole
n /N (%)
T. Bilirubin > 1.5x ULN 8/185 (4.3) 7/186 (3.8)
AST > 3.0x ULN 38/187 (20.3) 15/186 (8.1)
ALT > 3.0x ULN 20/187 (10.7) 12/186 (6.5)
Alk phos > 3.0x ULN 19/187 (10.2) 14/186 (7.5)
* Without regard to baseline value
n = number of patients with a clinically significant abnormality while on study therapy
N = total number of patients with at least one observation of the given lab test while on study therapy
ULN = upper limit of normal

Table 5: Protocol 307/602 - Primary Treatment of Invasive Aspergillosis Clinically Significant Laboratory Test Abnormalities

Criteria* Voriconazole
n/N (%)
Amphotericin B**
n/N (%)
T. Bilirubin > 1.5x ULN 35/180 (19.4) 46/173 (26.6)
AST > 3.0x ULN 21/180 (11.7) 18/174 (10.3)
ALT > 3.0x ULN 34/180 (18.9) 40/173 (23.1)
Alk phos > 3.0x ULN 29/181 (16.0) 38/173 (22.0)
Creatinine > 1.3x ULN 39/182 (21.4) 102/177 (57.6)
Potassium < 0.9x LLN 30/181 (16.6) 70/178 (39.3)
* Without regard to baseline value
**Amphotericin B followed by other licensed antifungal therapy
n = number of patients with a clinically significant abnormality while on study therapy
N = total number of patients with at least one observation of the given lab test while on study therapy
ULN = upper limit of normal LLN = lower limit of normal

Table 6: Protocol 608 - Treatment of Candidemia Clinically Significant Laboratory Test Abnormalities

Criteria* Voriconazole
n/N (%)
Amphotericin B followed by Fluconazole
n/N (%)
T. Bilirubin > 1.5x ULN 50/261 (19.2) 31/115 (27.0)
AST > 3.0x ULN 40/261 (15.3) 16/116 (13.8)
ALT > 3.0x ULN 22/261 (8.4) 15/116 (12.9)
Alk phos > 3.0x ULN 59/261 (22.6) 26/115 (22.6)
Creatinine > 1.3x ULN 39/260 (15.0) 32/118 (27.1)
Potassium < 0.9x LLN 43/258 (16.7) 35/118 (29.7)
* Without regard to baseline value
n = number of patients with a clinically significant abnormality while on study therapy
N = total number of patients with at least one observation of the given lab test while on study therapy
ULN = upper limit of normal
LLN = lower limit of normal

Postmarketing Experience

The following adverse reactions have been identified during post approval use of voriconazole. Because these reactions are 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.

Skeletal: fluorosis and periostitis have been reported during long-term voriconazole therapy [see WARNINGS AND PRECAUTIONS].

Read the entire FDA prescribing information for Vfend (Voriconazole) »

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Vfend - User Reviews

Vfend User Reviews

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Here is a collection of user reviews for the medication Vfend sorted by most helpful. Patient Discussions FAQs

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