Voriconazole (Page 6 of 15)
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 DiscontinuationIn 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 in the pooled pediatric clinical trials are displayed by body system, in Table 8.
Body System | Adverse Reaction | Pooled Pediatric Data *N=105 n (%) |
---|---|---|
Abbreviations: ALT = alanine aminotransferase; LFT = liver function test | ||
| ||
Blood and Lymphatic Systems Disorders | Thrombocytopenia | 10 (10) |
Cardiac Disorders | Tachycardia | 7 (7) |
Eye Disorders | Visual Disturbances † | 27 (26) |
Photophobia | 6 (6) | |
Gastrointestinal Disorders | Vomiting | 21 (20) |
Nausea | 14 (13) | |
Abdominal pain ‡ | 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 § | 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 ¶ | 5 (5) |
Renal and Urinary Disorders | Renal impairment # | 5 (5) |
Respiratory Disorders | Epistaxis | 17 (16) |
Cough | 10 (10) | |
Dyspnea | 6 (6) | |
Hemoptysis | 5 (5) | |
Skin and Subcutaneous Tissue Disorders | Rash Þ | 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
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