Itrazole Adverse Reactions

Summary of the safety profile: The most frequently reported adverse drug reactions (ADRs) with ITRACONAZOLE Capsules treatment identified from clinical trials and/or from spontaneous reporting were headache, abdominal pain, and nausea. The most serious ADRs were serious allergic reactions, cardiac failure/congestive heart failure/pulmonary oedema, pancreatitis, serious hepatotoxicity (including some cases of fatal acute liver failure), and serious skin reactions. Refer to subsection Tabulated list of adverse reactions for the frequencies and for other observed ADRs.
Tabulated list of adverse reactions: The ADRs in the table as follows were derived from open-label and double-blind clinical trials with Itraconazole Capsules involving 8499 patients in the treatment of dermatomycoses or onychomycosis, and from spontaneous reporting.
The table as follows presents ADRs by System Organ Class. Within each System Organ Class, the ADRs are presented by incidence, using the following convention: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000). (See Table 3.)

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Pediatric population: The safety of Itraconazole Capsules was evaluated in 165 pediatric patients aged 1 to 17 years who participated in 14 clinical trials (4 double-blind, placebo controlled trials; 9 open-label trials; and 1 trial had an open-label phase followed by a double-blind phase). These patients received at least one dose of Itraconazole Capsules for the treatment of fungal infections and provided safety data.
Based on pooled safety data from these clinical trials, the commonly reported adverse drug reactions (ADRs) in pediatric patients were Headache (3.0%), Vomiting (3.0%), Abdominal pain (2.4%), Diarrhoea (2.4%), Hepatic function abnormal (1.2%), Hypotension (1.2%), Nausea (1.2%), and Urticaria (1.2%). In general, the nature of ADRs in pediatric patients is similar to that observed in adult subjects, but the incidence is higher in the pediatric patients.
ADR Reporting Statement: Patient to seek medical attention immediately at the first sign of any adverse reaction.