Voriconazole

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• Dosage in
• Adults ( 2.3 ) Infection Maintenance Dose Oral tablets Oral suspension Invasive Aspergillosis 200 mg every 12 hours 5 mL every 12 hours Candidemia in nonneutropenics and other deep tissue Candida infections 200 mg every 12 hours 5 mL every 12 hours Scedosporiosis and Fusariosis 200 mg every 12 hours 5 mL every 12 hours Esophageal Candidiasis 200 mg every 12 hours 5 mL every 12 hours Adult patients weighing less than 40 kg:
• oral maintenance dose 100 mg or 150 mg every 12 hours Hepatic Impairment:
• Use half the maintenance dose in adult patients with mild to moderate hepatic impairment (Child-Pugh Class A and B) ( 2.5 ) 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 ) 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.
• Infection Maintenance Dose Oral tablets Oral suspension Invasive Aspergillosis 9 mg/kg every 12 hours (maximum dose of 350 mg every 12 hours) 0.225 mL/kg every 12 hours [maximum dose of 8.75 mL (350 mg) every 12 hours] Candidemia in nonneutropenics and other deep tissue Candida infections Scedosporiosis and Fusariosis Esophageal Candidiasis 9 mg/kg every 12 hours (maximum dose of 350 mg every 12 hours) 0.225 mL/kg every 12 hours [maximum dose of 8.75 mL (350 mg) every 12 hours] For pediatric patients aged 12 to 14 years weighing greater than or equal to 50 kg and those aged 15 years and older regardless of body weight use adult dosage.
• ( 2.4 ) Dosage adjustment of voriconazole tablets in pediatric patients with renal or hepatic impairment has not been established ( 2.5 , 2.6 )
• 2.1 Important Administration Instructions for Use in All Patients Administer voriconazole tablets at least one hour before or after a meal.
• Recommended Dosing Regimen in
• Adults Invasive aspergillosis and serious fungal infections due to Fusarium spp. and Scedosporium apiospermum See Table 1.
• Therapy must be initiated with the specified loading dose regimen of intravenous voriconazole on Day 1 followed by the recommended maintenance dose (RMD) regimen.
• Intravenous treatment should be continued for at least 7 days.
• Once the patient has clinically improved and can tolerate medication given by mouth, the oral tablet form of voriconazole may be utilized.
• The recommended oral maintenance dose of 200 mg achieves a voriconazole exposure similar to 3 mg/kg intravenously; a 300 mg oral dose achieves an exposure similar to 4 mg/kg intravenously [see Clinical Pharmacology ( 12.3 )] .
• Candidemia in non-neutropenic patients and other deep tissue Candida infections See Table 1.
• Patients should be treated for at least 14 days following resolution of symptoms or following last positive culture, whichever is longer.
• Esophageal Candidiasis See Table 1.
• Patients should be treated for a minimum of 14 days and for at least 7 days following resolution of symptoms.
• Table 1:
• Recommended Dosing Regimen (Adults) a Increase dose when voriconazole tablets are coadministered with phenytoin or efavirenz (7);
• Decrease dose in patients with hepatic impairment ( 2.5 ) b In healthy volunteer studies, the 200 mg oral every 12 hours dose provided an exposure (AUCτ) similar to a 3 mg/kg intravenous infusion every 12 hours dose; the 300 mg oral every 12 hours dose provided an exposure (AUCτ) similar to a 4 mg/kg intravenous infusion every 12 hours dose ( 12 ) c Adult patients who weigh less than 40 kg should receive half of the oral maintenance dose. d In a clinical study of IA, the median duration of intravenous voriconazole therapy was 10 days (range 2 to 85 days).
• The median duration of oral voriconazole therapy was 76 days (range 2 to 232 days) ( 14.1 ). e In clinical trials, patients with candidemia received 3 mg/kg intravenous infusion every 12 hours as primary therapy, while patients with other deep tissue Candida infections received 4 mg/kg every 12 hours as salvage therapy.
• Appropriate dose should be based on the severity and nature of the infection. f Not evaluated in patients with EC.
• Infection Loading Dose Maintenance Dose a,b Intravenous infusion Intravenous infusion Oral tablets c Oral suspension Invasive Aspergillosis d 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 nonneutropenic patients and other deep tissue Candida infections 6 mg/kg every 12 hours for the first 24 hours 3-4 mg/kg every 12 hours e 200 mg every 12 hours 5 mL every 12 hours Esophageal Candidiasis Not Evaluated f Not Evaluated f 200 mg every 12 hours 5 mL every 12 hours Scedosporiosis and Fusariosis 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 Method for Adjusting the Dosing Regimen in
• Adults If the patient’s response is inadequate, the oral maintenance dose for voriconazole tablets or oral suspension may be increased from 200 mg (or 5 mL) every 12 hours to 300 mg (or 7.5 mL) every 12 hours.
• For adult patients weighing less than 40 kg, the oral maintenance dose for voriconazole tablets or oral suspension may be increased from 100 mg (or 2.5 mL) every 12 hours to 150 mg (or 3.75 mL) every 12 hours.
• If the patient is unable to tolerate 300 mg (or 7.5 mL) orally every 12 hours, reduce the oral maintenance dose of voriconazole tablets or oral suspension by 50 mg (or 1.25 mL) steps to a minimum of 200 mg (or 5 mL) every 12 hours for adult patients weighing more than 40 kg or to 100 mg (or 2.5 mL) every 12 hours for adult patients weighing less than 40 kg.
• If the patient is unable to tolerate 4 mg/kg intravenously every 12 hours, reduce the intravenous maintenance dose to 3 mg/kg every 12 hours.
• 2.4 Recommended Dosing Regimen in Pediatric Patients The recommended dosing regimen for pediatric patients 2 to less than 12 years of age and 12 to 14 years of age with body weight less than 50 kg is shown in Table 2.
• For pediatric patients 12 to 14 years of age with a body weight greater than or equal to 50 kg and those 15 years of age and above regardless of body weight, administer the adult dosing regimen of voriconazole tablets [see Dosage and Administration ( 2.3 )] .
• Table 2:
• Recommended Dosing Regimen for Pediatric Patients 2 to less than 12 years of age and 12 to 14 years of age with body weight less than 50 kg^ ^ Based on a population pharmacokinetic analysis in 112 immunocompromised pediatric patients aged 2 to less than 12 years of age and 26 immunocompromised pediatric patients aged 12 to less than 17 years of age. * In the Phase 3 clinical trials, patients with IA received intravenous (IV) treatment for at least 6 weeks and up to a maximum of 12 weeks.
• Patients received IV treatment for at least the first 7 days of therapy and then could be switched to oral voriconazole therapy. † Study treatment for primary or salvage invasive candidiasis and candidemia (ICC) or EC consisted of intravenous voriconazole, with an option to switch to oral therapy after at least 5 days of IV therapy, based on subjects meeting switch criteria.
• For subjects with primary or salvage ICC, voriconazole was administered for at least 14 days after the last positive culture.
• A maximum of 42 days of treatment was permitted.
• Patients with primary or salvage EC were treated for at least 7 days after the resolution of clinical signs and symptoms.
• A maximum of 42 days of treatment was permitted.
• Loading Dose Maintenance Dose Intravenous infusion Intravenous infusion Oral tablets Oral suspension Invasive Aspergillosis* 9 mg/kg every 12 hours for the first 24 hours 8 mg/kg every 12 hours after the first 24 hours 9 mg/kg every 12 hours (maximum dose of 350 mg every 12 hours) 0.225 mL/kg every 12 hours [maximum dose of 8.75 mL (350 mg) every 12 hours] Candidemia in nonneutropenics and other deep tissue Candida infections † Scedosporiosis and Fusariosis Esophageal Candidiasis † Not Evaluated 4 mg/kg every 12 hours 9 mg/kg every 12 hours (maximum dose of 350 mg every 12 hours) 0.225 mL/kg every 12 hours [maximum dose of 8.75 mL (350 mg) every 2 hours] Initiate therapy with an intravenous infusion regimen.
• Consider an oral regimen only after there is a significant clinical improvement.
• Note that an 8 mg/kg intravenous dose will provide voriconazole exposure approximately 2-fold higher than a 9 mg/kg oral dose.
• The oral dose recommendation for children is based on studies in which voriconazole was administered as the powder for oral suspension formulation.
• Bioequivalence between the voriconazole powder for oral suspension and voriconazole tablets has not been investigated in a pediatric population.
• Oral bioavailability may be limited in pediatric patients 2 to 12 years with malabsorption and very low body weight for age.
• In that case, intravenous voriconazole administration is recommended.
• Method for Adjusting the Dosing Regimen in Pediatric Patients Pediatric Patients 2 to less than 12 years of age and 12 to 14 years of age with body weight less than 50 kg If patient response is inadequate and the patient is able to tolerate the initial intravenous maintenance dose, the maintenance dose may be increased by 1 mg/kg steps.
• If patient response is inadequate and the patient is able to tolerate the oral maintenance dose, the dose may be increased by 1 mg/kg (0.025 mL/kg) steps or 50 mg (1.25 mL) steps to a maximum of 350 mg (8.75 mL) every 12 hours.
• If patients are unable to tolerate the initial intravenous maintenance dose, reduce the dose by 1 mg/kg steps.
• If patients are unable to tolerate the oral maintenance dose, reduce the dose by 1 mg/kg (0.025 mL/kg) or 50 mg (1.25 mL) steps.
• Pediatric patients 12 to 14 years of age weighing greater than or equal to 50 kg and 15 years of age and older regardless of body weight:
• Use the optimal method for titrating dosage recommended for
• adults [see Dosage and Administration ( 2.3 )] .
• Dosage Modifications in Patients With Hepatic Impairment
• Adults The maintenance dose of voriconazole should be reduced in adult patients with mild to moderate hepatic impairment, Child-Pugh Class A and B.
• There are no PK data to allow for dosage adjustment recommendations in patients with severe hepatic impairment (Child-Pugh Class C).
• Duration of therapy should be based on the severity of the patient’s underlying disease, recovery from immunosuppression, and clinical response.
• Adult patients with baseline liver function tests (ALT, AST) of up to 5 times the upper limit of normal (ULN) were included in the clinical program.
• Dose adjustments are not necessary for adult patients with this degree of abnormal liver function, but continued monitoring of liver function tests for further elevations is recommended [see Warnings and Precautions ( 5.1 )] .
• It is recommended that the recommended voriconazole loading dose regimens be used, but that the maintenance dose be halved in adult patients with mild to moderate hepatic cirrhosis (Child-Pugh Class A and B) [see Clinical Pharmacology ( 12.3 )] .
• Voriconazole has not been studied in adult patients with severe hepatic cirrhosis (Child-Pugh Class C) or in patients with chronic hepatitis B or chronic hepatitis C disease.
• Voriconazole has been associated with elevations in liver function tests and with clinical signs of liver damage, such as jaundice.
• Voriconazole tablets should only be used in patients with severe hepatic impairment if the benefit outweighs the potential risk.
• Patients with hepatic impairment must be carefully monitored for drug toxicity.
• Pediatric Patients Dosage adjustment of voriconazole tablets in pediatric patients with hepatic impairment has not been established [see Use in Specific Populations ( 8.4 )] .
• 2.6 Dosage Modifications in Patients With Renal Impairment Adult Patients The pharmacokinetics of orally administered voriconazole tablets are not significantly affected by renal impairment.
• Therefore, no adjustment is necessary for oral dosing in patients with mild to severe renal impairment [see Clinical Pharmacology ( 12.3 )] .
• In patients with moderate or severe renal impairment (creatinine clearance <50 mL/min) who are receiving an intravenous infusion of voriconazole, accumulation of the intravenous vehicle, SBECD, occurs.
• Oral voriconazole should be administered to these patients, unless an assessment of the benefit/risk to the patient justifies the use of intravenous voriconazole.
• Serum creatinine levels should be closely monitored in these patients, and, if increases occur, consideration should be given to changing to oral voriconazole therapy [see Warnings and Precautions ( 5.7 )] .
• Voriconazole and the intravenous vehicle, SBECD, are dialyzable.
• A 4-hour hemodialysis session does not remove a sufficient amount of voriconazole to warrant dose adjustment [see Clinical Pharmacology ( 12.3 )] .
• Pediatric Patients Dosage adjustment of voriconazole tablets in pediatric patients with renal impairment has not been established [see Use in Specific Populations ( 8.4 )] .
• 2.7 Dosage Adjustment When Coadministered With Phenytoin or Efavirenz The maintenance dose of voriconazole should be increased when coadministered with phenytoin or efavirenz.
• Use the optimal method for titrating dosage [see Drug Interactions ( 7 ) and Dosage and Administration ( 2.3 )] .

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Quoted from the official label, section “Overdosage”.

Use in children

• The safety and effectiveness of voriconazole have been established in pediatric patients 2 years of age and older based on evidence from adequate and well-controlled studies in adult and pediatric patients and additional pediatric pharmacokinetic and safety data.
• A total of 105 pediatric patients aged 2 to less than 12 [N=26] and aged 12 to less than 18 [N=79] from two, non-comparative Phase 3 pediatric studies and eight adult therapeutic trials provided safety information for voriconazole use in the pediatric population [see Adverse Reactions ( 6.1 ), Clinical Pharmacology ( 12.3 ), and Clinical Studies ( 14 )].
• Safety and effectiveness in pediatric patients below the age of 2 years has not been established.
• Therefore, voriconazole is not recommended for pediatric patients less than 2 years of age.
• A higher frequency of liver enzyme elevations was observed in the pediatric patients [see Dosage and Administration ( 2.5 ), Warnings and Precautions ( 5.1 ), and Adverse Reactions ( 6.1 )].
• The frequency of phototoxicity reactions is higher in the pediatric population.
• Squamous cell carcinoma has been reported in patients who experience photosensitivity reactions.
• Stringent measures for photoprotection are warranted.
• Sun avoidance and dermatologic follow-up are recommended in pediatric patients experiencing photoaging injuries, such as lentigines or ephelides, even after treatment discontinuation [see Warnings and Precautions ( 5.6 )].
• Voriconazole has not been studied in pediatric patients with hepatic or renal impairment [see Dosage and Administration ( 2.5 , 2.6 )].
• Hepatic function and serum creatinine levels should be closely monitored in pediatric patients [see Dosage and Administration ( 2.6 ) and Warnings and Precautions ( 5.1 , 5.10 )].

Quoted from the official label, section “Pediatric Use”.

Use in older people

• In multiple dose therapeutic trials of voriconazole, 9.2% of patients were ≥65 years of age and 1.8% of patients were ≥75 years of age.
• In a study in healthy subjects, the systemic exposure (AUC) and peak plasma concentrations (C max ) were increased in elderly males compared to young males.
• Pharmacokinetic data obtained from 552 patients from 10 voriconazole therapeutic trials showed that voriconazole plasma concentrations in the elderly patients were approximately 80% to 90% higher than those in younger patients after either IV or oral administration.
• However, the overall safety profile of the elderly patients was similar to that of the young so no dosage adjustment is recommended [see Clinical Pharmacology ( 12.3 )].

Quoted from the official label, section “Geriatric Use”.

Side effects

• 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 )] 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 Ajanta Pharma USA Inc. at 855-664-7744 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 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.
• Clinical Trials Experience in
• Adults Overview The most frequently reported adverse reactions (see Table 4) in the adult 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 adverse reactions which most often led to discontinuation of voriconazole therapy were elevated liver function tests, rash, and visual disturbances [see Warning and Precautions ( 5.1 , 5.4 ) and Adverse Reactions ( 6.1 ) ].
• The data described in Table 4 reflect exposure to voriconazole in 1655 patients in nine 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 4 includes all adverse reactions 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 (OLAT) in the primary treatment of patients with acute IA.
• The rate of discontinuation from voriconazole study medication due to adverse reactions 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 reactions 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 EC.
• The rate of discontinuation from voriconazole study medication in Study 305 due to adverse reactions was 7% (14/200 patients).
• Laboratory test abnormalities for these studies are discussed under Clinical Laboratory Values below.
• Table 4:
• Adverse Reactions Rate ≥ 2% on Voriconazole or Adverse Reactions of Concern in Therapeutic Studies Population, Studies 307/602-608 Combined, or Study 305.
• Possibly Related to Therapy or Causality Unknown† † Study 307/602: IA;
• Study 608: candidemia;
• Study 305:
• EC * Studies 303, 304, 305, 307, 309, 602, 603, 604, 608 **Amphotericin B followed by other licensed antifungal therapy *** See Warnings and Precautions ( 5.4 ) 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 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.
• 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.
• These effects were noted early in administration of voriconazole and continued through the course of study drug treatment.
• Fourteen days after the end of dosing, ERG, visual fields and color perception returned to normal [see Warnings and Precautions ( 5.4 ) ].
• Dermatological Reactions Dermatological reactions were common in patients treated with voriconazole.
• The mechanism underlying these dermatologic adverse reactions remains unknown.
• Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported during treatment with voriconazole tablets.
• Erythema multiforme has also been reported during treatment with voriconazole tablets. [see Warnings and Precautions ( 5.5 ) and Adverse Reaction ( 6.2 )] .
• Voriconazole tablets have also been associated with additional photosensitivity related skin reactions such as pseudoporphyria, cheilitis, and cutaneous lupus erythematosus [see Warnings and Precautions ( 5.6 ) and Adverse Reactions ( 6.2 )].
• Less Common Adverse Reactions The following adverse reactions 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 4 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, 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 ( 5.2 )].
• 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 (including cutaneous SCC in situ, or Bowen’s disease), 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 in
• Adults The overall incidence of transaminase increases >3x upper limit of normal (not necessarily comprising an adverse reaction) was 17.7% (268/1514) in adult subjects treated with voriconazole for therapeutic use in pooled clinical trials.
• 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 resolved 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 voriconazole tablets therapy.
• Patients who develop abnormal liver function tests during voriconazole tablets 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 voriconazole tablets must be considered if clinical signs and symptoms consistent with liver disease develop that may be attributable to voriconazole tablets [see Warnings and Precautions ( 5.1 )].
• Acute renal failure has been observed in severely ill patients undergoing treatment with voriconazole tablets.
• Patients being treated with voriconazole are likely to be treated concomitantly with nephrotoxic medications and may have concurrent conditions that can result in decreased renal function.
• It is recommended that patients are monitored for the development of abnormal renal function.
• This should include laboratory evaluation of serum creatinine.
• Tables 5 to 7 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 EC were randomized to either oral voriconazole or oral fluconazole.
• In study 307/602, patients with definite or probable IA 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 5:
• Protocol 305 – Patients with Esophageal CandidiasisClinically Significant Laboratory Test Abnormalities * 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 AST = Aspartate aminotransferase;
• ALT= alanine aminotransferase ULN = upper limit of normal Criteria* Voriconazole Fluconazole n/N (%) 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) Alkaline Phosphatase >3.0x ULN 19/187 (10.2) 14/186 (7.5) Table 6:
• Protocol 307/602 – Primary Treatment of Invasive Aspergillosis Clinically Significant Laboratory Test Abnormalities * 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 AST = Aspartate aminotransferase;
• ALT= alanine aminotransferase ULN = upper limit of normal LLN = lower limit of normal Criteria* Voriconazole Amphotericin B** n/N (%) 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) Alkaline Phosphatase >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) Table 7:
• Protocol 608 – Treatment of Candidemia Clinically Significant Laboratory Test Abnormalities * 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 AST = Aspartate aminotransferase;
• ALT= alanine aminotransferase ULN = upper limit of normal LLN = lower limit of normal Criteria* Voriconazole Amphotericin B followed by Fluconazole n/N (%) 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) Alkaline Phosphatase >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) Clinical Trials Experience in Pediatric Patients The safety of voriconazole was investigated in 105 pediatric patients aged 2 to less than 18 years, including 52 pediatric patients less than 18 years of age who were enrolled in the adult therapeutic studies.
• Serious Adverse Reactions and Adverse Reactions Leading to Discontinuation In clinical studies, serious adverse reactions occurred in 46% (48/105) of voriconazole treated pediatric patients.
• Treatment discontinuations due to adverse reactions occurred in 12 /105 (11%) of all patients.
• Hepatic adverse reactions (i.e.
• ALT increased; liver function test abnormal; jaundice) 6% (6/105) accounted for the majority of voriconazole treatment discontinuations.
• Most Common Adverse Reactions The most common adverse reactions occurring in ≥5% of pediatric patients receiving voriconazole tablets in the pooled pediatric clinical trials are displayed by body system, in Table 8.
• Table 8:
• Adverse Reactions Occurring in ≥5% of Pediatric Patients ReceivingVoriconazole tablets in the Pooled Pediatric Clinical Trials a Reflects all adverse reactions and not treatment-related only. b Pooled reports include such terms as:
• amaurosis (partial or total blindness without visible change in the eye); asthenopia (eye strain); chromatopsia (abnormally colored vision); color blindness; diplopia; photopsia; retinal disorder; vision blurred, visual acuity decreased, visual brightness; visual impairment.
• Several patients had more than one visual disturbance. c Pooled reports include such terms as:
• abdominal pain and abdominal pain, upper. d Pooled reports include such terms as:
• ALT abnormal and ALT increased. e Pooled reports include such terms as:
• hallucination; hallucination, auditory; hallucination, visual.
• Several patients had both visual and auditory hallucinations. f Pooled reports include such terms as:
• renal failure and a single patient with renal impairment. g Pooled reports include such terms as:
• rash; rash generalized; rash macular; rash maculopapular; rash pruritic.
• Abbreviations: ALT = alanine aminotransferase;
• LFT = liver function test Body System Adverse Reaction Pooled Pediatric Data a N=105 n (%) Blood and Lymphatic Systems Disorders Thrombocytopenia 10 (10) Cardiac Disorders Tachycardia 7 (7) Eye Disorders Visual Disturbances b 27 (26) Photophobia 6 (6) Gastrointestinal Disorders Vomiting 21 (20) Nausea 14 (13) Abdominal pain c 13 (12) Diarrhea 12 (11) Abdominal distention 5 (5) Constipation 5 (5) General Disorders and Administration Site Conditions Pyrexia 25 (25) Peripheral edema 9 (9) Mucosal inflammation 6 (6) Infections and Infestations Upper respiratory tract infection 5 (5) Investigations ALT abnormal d 9 (9) LFT abnormal 6 (6) Metabolism and Nutrition Disorders Hypokalemia 11 (11) Hyperglycemia 7 (7) Hypocalcemia 6 (6) Hypophosphotemia 6 (6) Hypoalbuminemia 5 (5) Hypomagnesemia 5 (5) Nervous System Disorders Headache 10 (10) Dizziness 5 (5) Psychiatric Disorders Hallucinations e 5 (5) Renal and Urinary Disorders Renal impairment f 5 (5) Respiratory Disorders Epistaxis 17 (16) Cough 10 (10) Dyspnea 6 (6) Hemoptysis 5 (5) Skin and Subcutaneous Tissue Disorders Rash g 14 (13) Vascular Disorders Hypertension 12 (11) Hypotension 9 (9) The following adverse reactions with incidence less than 5% were reported in 105 pediatric patients treated with voriconazole:
• Blood and Lymphatic System Disorders:
• anemia, leukopenia, pancytopenia Cardiac Disorders:
• bradycardia, palpitations, supraventricular tachycardia Eye Disorders:
• dry eye, keratitis Ear and Labyrinth Disorders:
• tinnitus, vertigo Gastrointestinal Disorders:
• abdominal tenderness, dyspepsia General Disorders and Administration Site Conditions:
• asthenia, catheter site pain, chills, hypothermia, lethargy Hepatobiliary Disorders:
• cholestasis, hyperbilirubinemia, jaundice Immune System Disorders:
• hypersensitivity, urticaria Infections and Infestations:
• conjunctivitis Laboratory Investigations:
• AST increased, blood creatinine increased, gamma-glutamyl transferase increased Metabolism and Nutrition Disorders:
• hypercalcemia, hypermagnesemia, hyperphosphatemia, hypoglycemia Musculoskeletal and Connective Tissue Disorders:
• arthralgia, myalgia Nervous System Disorders:
• ataxia , convulsion, dizziness, nystagmus, paresthesia, syncope Psychiatric Disorders:
• affect lability, agitation, anxiety, depression, insomnia Respiratory Disorders:
• bronchospasm, nasal congestion, respiratory failure, tachypnea Skin and Subcutaneous Tissue Disorders:
• alopecia, dermatitis (allergic, contact, and exfoliative), pruritus Vascular Disorders:
• flushing, phlebitis Hepatic-Related Adverse Reactions in Pediatric Patients The frequency of hepatic-related adverse reactions in pediatric patients exposed to voriconazole in therapeutic studies was numerically higher than that of
• adults (28.6% compared to 24.1%, respectively).
• The higher frequency of hepatic adverse reactions in the pediatric population was mainly due to an increased frequency of liver enzyme elevations (21.9% in pediatric patients compared to 16.1% in
• adults), including transaminase elevations (ALT and AST combined) 7.6% in the pediatric patients compared to 5.1% in
• adults.
• Clinical Laboratory Values in Pediatric Patients The overall incidence of transaminase increases >3x upper limit of normal was 27.2% (28/103) in pediatric and 17.7% (268/1514) in adult patients treated with voriconazole in pooled clinical trials.
• The majority of abnormal liver function tests either resolved on treatment with or without dose adjustment or after voriconazole discontinuation.
• A higher frequency of clinically significant liver laboratory abnormalities, irrespective of baseline laboratory values (>3x ULN ALT or AST), was consistently observed in the combined therapeutic pediatric population (15.5% AST and 22.5% ALT) when compared to
• adults (12.9% AST and 11.6% ALT).
• The incidence of bilirubin elevation was comparable between adult and pediatric patients.
• The incidence of hepatic abnormalities in pediatric patients is shown in Table 9.
• Table 9:
• Incidence of Hepatic Abnormalities among Pediatric Subjects n = number of patients with a clinically significant abnormality while on study therapyN = total number of patients with at least one observation of the given lab test while on study therapy AST = Aspartate aminotransferase;
• ALT = alanine aminotransferase ULN = upper limit of normal Criteria n/N (%) Total bilirubin >1.5x ULN 19/102 (19) AST >3.0x ULN 16/103 (16) ALT >3.0x ULN 23/102 (23) Alkaline Phosphatase >3.0x ULN 8/97 (8)
• 6.2 Postmarketing Experience in Adult and Pediatric Patients 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.
• Dermatological Reactions Increased risk of skin toxicity with concomitant use of methotrexate, a drug associated with UV reactivation, was observed in postmarketing reports [see Warnings and Precautions ( 5.6 ) and Adverse Reactions ( 6.1 )].
• Adults Skeletal :
• fluorosis and periostitis have been reported during long-term voriconazole therapy [see Warnings and Precautions ( 5.12 )] .
• Eye disorders :
• prolonged visual adverse reactions, including optic neuritis and papilledema [see Warnings and Precautions ( 5.4 )] .
• Skin and Appendages:
• drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported [see Warnings and Precautions ( 5.5 ) and Adverse Reactions ( 6.1 )].
• Endocrine disorders:
• adrenal insufficiency, Cushing’s syndrome (when voriconazole has been used concomitantly with corticosteroids) [see Warnings and Precautions ( 5.8 )] .
• Pediatric Patients There have been postmarketing reports of pancreatitis in pediatric patients.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• Advise the patient to read the FDA-approved patient labeling (Patient Information).
• Visual Disturbances Patients should be instructed that visual disturbances such as blurring and sensitivity to light may occur with the use of voriconazole tablets.
• Photosensitivity Advise patients of the risk of photosensitivity (with or without concomitant methotrexate), accelerated photoaging, and skin cancer.
• Advise patients that voriconazole tablets can cause serious photosensitivity and to immediately contact their healthcare provider for new or worsening skin rash.
• Advise patients to
• avoid exposure to direct sun light and to use measures such as protective clothing and sunscreen with high sun protection factor (SPF).
• Embryo-Fetal Toxicity Advise female patients of the potential risks to a fetus.
• Advise females of reproductive potential to use effective contraception during treatment with voriconazole tablets.
• Product of India Manufactured by:
• Ajanta Pharma Limited, India Marketed by:
• Ajanta Pharma USA Inc.
• Bridgewater, NJ 08807.
• Revised:
• 04/2026 PATIENT INFORMATION Voriconazole (vor” i kon’ a zole) Tablets, for oral use Read the Patient Information that comes with voriconazole tablets before you start taking it and each time
• you get a refill.
• There may be new information.
• This information does not take the place of talking with your healthcare provider about your condition or treatment.
• What are voriconazole tablets? Voriconazole tablets are a prescription medicine used to treat certain serious fungal infections in your blood and body.
• These infections are called “aspergillosis,” “esophageal candidiasis,” “ Scedosporium, ” “ Fusarium, ” and “candidemia”.
• It is not known if voriconazole tablets are safe and effective in children younger than 2 years old.
• Do not take voriconazole tablets
• if you:
• are allergic to voriconazole or any of the ingredients in voriconazole tablets .
• See the end of this leaflet for a complete list of ingredients in voriconazole tablets. are taking any of the following medicines:
• o carbamazepine o efavirenz o eplerenone o ergotamine, dihydroergotamine (ergot alkaloids) o finerenone o ivabradine o long-acting barbiturates like phenobarbital o lurasidone o naloxegol o pimozide o quinidine o rifabutin o rifampin o ritonavir o sirolimus o St.John’s Wort (herbal supplement) o tolvaptan o venetoclax o voclosporin Ask your healthcare provider or pharmacist
• if you are not sure
• if you are taking any of the medicines listed above.
• Do not start taking a new medicine without talking to your healthcare provider or pharmacist.
• Before
• you take voriconazole tablets, tell your healthcare provider about all of your medical conditions, including
• if you:
• have or ever had heart disease, or an abnormal heart rate or rhythm.
• Your healthcare provider may order a test to check your heart (EKG) before starting voriconazole tablets. have low potassium levels, low magnesium levels, and low calcium levels.
• Your healthcare provider may do blood tests before starting and during treatment with voriconazole tablets. have liver or kidney problems.
• Your healthcare provider may do blood tests to make sure you can take voriconazole tablets. have trouble digesting dairy products, lactose (milk sugar), or regular table sugar.
• Voriconazole tablets contain lactose. are pregnant or plan to become pregnant.
• Voriconazole tablets can harm your unborn baby.
• Talk to your healthcare provider if you are pregnant or plan to become pregnant.
• Women who can become pregnant should use effective birth control while taking voriconazole tablets.
• Talk to your healthcare provider about birth control methods that may be right for you. are breastfeeding or plan to breastfeed.
• It is not known if voriconazole passes into breast milk.
• Talk to your healthcare provider about the best way to feed your baby
• if you take voriconazole tablets.
• Tell your healthcare provider about all the medicines
• you take , including prescription and over-the-counter medicines, vitamins and herbal supplements.
• Voriconazole tablets may affect the way other medicines work, and other medicines may affect how voriconazole tablet works.
• Know what medicines you take.
• Keep a list of them to show your healthcare provider or pharmacist when
• you get a new medicine.
• How should I take voriconazole tablets? Voriconazole may be prescribed to you as :
• Voriconazole tablets Take voriconazole tablets exactly as your healthcare provider tells you to.
• Take voriconazole tablets at least 1 hour before or at least 1 hour after meals.
• If you take too much voriconazole tablets, call your healthcare provider or go to the nearest hospital emergency room.
• What should I
• avoid while taking voriconazole tablets? You should not drive at night while taking voriconazole tablets.
• Voriconazole tablets can cause changes in your vision such as blurring or sensitivity to light.
• Do not drive or operate machinery, or do other dangerous activities until you know how voriconazole tablet affects you.
• Avoid direct sunlight.
• Voriconazole tablets can make your skin sensitive to the sun and the light from sunlamps and tanning beds.
• You could get a severe sunburn.
• Use sunscreen and wear a hat and clothes that cover your skin
• if you have to be in sunlight.
• Talk to your healthcare provider if you get sunburn.
• What are the possible side effects of voriconazole tablets? Voriconazole tablets may cause serious side effects including:
• liver problems.
• Symptoms of liver problems may include:
• o itchy skin o flu-like symptoms o yellowing of your eyes o nausea or vomiting o feeling very tired serious heart problems.
• Voriconazole tablets may cause changes in your heart rate or rhythm, including your heart stopping (cardiac arrest). allergic reactions.
• Symptoms of an allergic reaction may include:
• o fever o chest tightness o nausea o flushing o sweating o trouble breathing o itching o feels like your heart is beating fast (tachycardia) o feel faint o skin rash vision changes.
• Symptoms of vision changes may include:
• blurred vision changes in the way you see colors serious skin reactions .
• Symptoms of serious skin reactions may include:
• rash or hives mouth sores blistering or peeling of your skin trouble swallowing or breathing sensitivity to light or sun (photosensitivity).
• Voriconazole tablets can cause serious photosensitivity.
• There is an increased chance of skin toxicity while taking voriconazole tablets.
• This can happen with or without taking other medicines like methotrexate.
• Photosensitivity reactions may also increase your risk of:
• faster skin aging from the sun skin cancer Call your healthcare provider right away
• if you get a new skin rash or your skin rash gets worse. kidney problems .
• Voriconazole tablets may cause new or worse problems with kidney function, including kidney failure.
• Your healthcare provider should check your kidney function while
• you are taking voriconazole tablets.
• Your healthcare provider will decide
• if you can keep taking voriconazole tablets. adrenal gland problems:
• Voriconazole tablets may cause reduced adrenal function (adrenal insufficiency).
• Voriconazole tablets may cause overactive adrenal function (Cushing’s syndrome) when voriconazole is used at the same time with corticosteroids.
• Symptoms of adrenal insufficiency include:
• o feeling tired o nausea and vomiting o abdominal pain o lack of energy o feeling dizzy or lightheaded o weakness o weight loss Symptoms of Cushing’s syndrome include:
• o weight gain o thinning skin o excessive hair growth o fatty hump between the shoulders (buffalo hump) and a rounded face (moon face) o bruising easily o excessive sweating o darkening of the skin on the stomach, thighs, breasts, and arms o high blood sugar inflammation of the pancreas (pancreatitis).
• Symptoms of pancreatitis may include pain in your stomach area (abdomen) that is severe and will not go away.
• The pain may be felt going from your abdomen to your back.
• The pain may happen with or without vomiting. bone problems.
• Voriconazole tablets may cause weakening of bones and bone pain.
• Tell your healthcare provider if you have bone pain.
• Call your healthcare provider or go to the nearest hospital emergency room right away
• if you have any of the symptoms listed above.
• The most common side effects of voriconazole tablets in
• adults include:
• o vision changes o nausea o hallucinations (seeing or hearing things that are not there) o rash o headache o abnormal liver function tests o chills o vomiting o fast heart beat (tachycardia) o fever The most common side effects of voriconazole tablets in children include:
• o fever o diarrhea o low platelet counts o abnormal liver function tests o low blood calcium levels o low blood phosphate levels o vision changes o rash o stomach pain o trouble breathing o dizziness o high blood pressure o cough o low blood pressure o swelling in the arms and legs o high blood sugar levels o headache o fast heart beat(tachycardia) o nose bleeds o low blood potassium levels o low blood levels of albumin o kidney problems o inflammation of mucous membranes o hallucinations (seeing or hearing things that are not there) o coughing up blood o constipation o low blood magnesium levels o fullness of the stomach area o vomiting o nausea o upper respiratory tract infection Tell your healthcare provider
• if you have any side effect that bothers you or that does not go away.
• These are not all the possible side effects of voriconazole tablets.
• Call your doctor for medical advice about side effects.
• You may report side effects to FDA at 1-800-FDA-1088.
• How should I store voriconazole tablets? Store voriconazole tablets at room temperature, between 59 °F to 86 °F (15°C to 30°C).
• Do not refrigerate or freeze.
• Keep voriconazole tablets in a tightly closed container.
• Safely throw away medicine that is out of date or no longer needed.
• Keep voriconazole tablets, as well as all other medicines, out of the reach of children.
• General information about the safe and effective use of voriconazole tablets.
• Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.
• Do not use voriconazole tablets for a condition for which it was not prescribed.
• Do not give voriconazole tablets to other people, even if they have the same symptoms that
• you have.
• It may harm them.
• You can ask your healthcare provider or pharmacist for information about voriconazole tablets that is written for health professionals.
• What are the ingredients of voriconazole tablets? Active ingredient : voriconazole USP.
• Inactive ingredients:
• Voriconazole tablets:
• croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone, pregelatinized starch, and a coating containing hypromellose, lactose monohydrate, titanium dioxide, and triacetin.
• Product of India Manufactured by:
• Ajanta Pharma Limited, India Marketed by:
• Ajanta Pharma USA Inc.
• Bridgewater, NJ 08807.
• This Patient Information has been approved by the U.S.
• Food and Drug Administration.
• Revised: 04/2026

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• FORMS AND STRENGTHS Tablets Voriconazole 50 mg tablets; white, round-shaped, biconvex, film-coated tablets debossed with ‘V50’ on one side and plain on other side.
• Voriconazole 200 mg tablets; white, oval-shaped, biconvex, film-coated tablets debossed with ‘V200’ on one side and plain on other side.
• Tablets : 50 mg, 200 mg

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• 16.1 How Supplied Tablets Voriconazole 50 mg tablets:
• white, round-shaped, biconvex, film-coated tablets debossed with ‘V50’ on one side and plain on other side.
• Bottles of 30 with child-resistant closure (NDC 27241-062-03) Voriconazole 200 mg tablets:
• white, oval-shaped, biconvex, film-coated tablets debossed with ‘V200’ on one side and plain on other side.
• Bottles of 30 with child-resistant closure (NDC 27241-063-03)
• 16.2 Storage Voriconazole tablets should be stored at 15°C to 30°C (59° F to 86°F) [see USP Controlled Room Temperature].

Quoted from the official label, section “How Supplied”.

What is in it

• Voriconazole USP, an azole antifungal agent is available as film-coated tablets for oral administration.
• The structural formula is:
• Voriconazole is designated chemically as (α R ,βS)-α-(2,4-difluorophenyl)-5- fluoro- β -methyl- α -(1 H- 1,2,4-traizol-l-ylmethyl)-4-pyrimidineethanol with an empirical formula of C 16 H 14 F 3 N 5 O and a molecular weight of 349.31 g/mole.
• Voriconazole drug substance is a white or almost white powder.
• Voriconazole tablets contain 50 mg or 200 mg of voriconazole.
• The inactive ingredients include croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone, pregelatinized starch, and a coating containing hypromellose, lactose monohydrate, titanium dioxide, and triacetin. str

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Same active substance, strength and form in other countries

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Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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