What the label lists and what reports show
Voriconazole side effects
Voriconazole's FDA label: “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 …” FAERS holds 30,201 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is pyrexia (1,442 reports).
- Generic listed
- A presentation discontinued
Check it at the source: the voriconazole FDA label on DailyMed (effective February 26, 2026, Roerig); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of VFEND?VFEND 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. VFEND 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: o blurred vision o changes in the way you see colors • serious skin reactions. […]
Source: FDA drug label, NDA021630 (Pf Prism Cv), as published by Roerig, effective February 26, 2026 (SPL set ce3ef5cf-3087-4d92-9d94-9eb8287228db), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe 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%) […]
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…
| Reaction | Voriconazole N=1655 N (%) | Voriconazole N=468 N (%) | Ampho B Amphotericin B followed by other licensed antifungal therapy N=185 N (%) | Ampho B→ Fluconazole N=131 N (%) | Voriconazole N=200 N (%) | Fluconazole N=191 N (%) |
|---|---|---|---|---|---|---|
| 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 |
| 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) |
| Tachycardia | 39 (2.4) | 6 (1.3) | 5 (2.7) | 0 | 0 | 0 |
| 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 |
| 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 |
| Hallucinations | 39 (2.4) | 13 (2.8) | 1 (0.5) | 0 | 0 | 0 |
| Rash | 88 (5.3) | 20 (4.3) | 7 (3.8) | 1 (0.8) | 3 (1.5) | 1 (0.5) |
| 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 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe 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. …
Source: FDA drug label, NDA021630 (Pf Prism Cv), as published by Roerig, effective February 26, 2026 (SPL set ce3ef5cf-3087-4d92-9d94-9eb8287228db), via openFDA; the full label on DailyMed
What do FAERS reports show?
30,201 reports list voriconazole among the medicines taken, each a report of something that happened, not proof the medicine caused it; 8,851 are coded as a death and 12,143 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 19 reactions below, 10 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Voriconazole: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions