Canditral Adverse Reactions

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the 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 clinical practice.
ITRACONAZOLE has been associated with rare cases of serious hepatotoxicity, including liver failure and death. Some of these cases had neither pre-existing liver disease nor a serious underlying medical condition. If clinical signs or symptoms develop that are consistent with liver disease, treatment should be discontinued and liver function testing performed. The risks and benefits of ITRACONAZOLE use should be reassessed. (See Precautions and Information for Patients under Patient Counselling Information.)
Adverse Events in the Treatment of Systemic Fungal Infections: Adverse event data were derived from 602 patients treated for systemic fungal disease in U.S. clinical trials that were immunocompromised or receiving multiple concomitant medications. Treatment was discontinued in 10.5% of patients due to adverse events. The median duration before discontinuation of therapy was 81 days (range: 2 to 776 days). The table lists adverse events reported by at least 1% of patients. (See Table 1.)

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Adverse events infrequently reported in all studies included constipation, gastritis, depression, insomnia, tinnitus, menstrual disorder, adrenal insufficiency, gynecomastia, and male breast pain.
Adverse Events Reported in Toenail Onychomycosis Clinical Trials: Patients in these trials were on a continuous dosing regimen of 200 mg once daily for 12 consecutive weeks.
The following adverse events led to temporary or permanent discontinuation of therapy. (See Table 2.)

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The following adverse events occurred with an incidence of greater than or equal to 1% (N=112): headache: 10%; rhinitis: 9%; upper respiratory tract infection: 8%; sinusitis, injury: 7%; diarrhea, dyspepsia, flatulence, abdominal pain, dizziness, rash: 4%; cystitis, urinary tract infection, liver function abnormality, myalgia, nausea: 3%; appetite increased, constipation, gastritis, gastroenteritis, pharyngitis, asthenia, fever, pain, tremor, herpes zoster, abnormal dreaming: 2%.
Adverse Events Reported in Fingernail Onychomycosis Clinical Trials: Patients in these trials were on a pulse regimen consisting of two 1-week treatment periods of 200 mg twice daily, separated by a 3-week period without drug.
The following adverse events led to temporary or permanent discontinuation of therapy. (See Table 3.)

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The following adverse events occurred with an incidence of greater than or equal to 1% (N=37): headache: 8%; pruritus, nausea, rhinitis: 5%; rash, bursitis, anxiety, depression, constipation, abdominal pain, dyspepsia, ulcerative stomatitis, gingivitis, hypertriglyceridemia, sinusitis, fatigue, malaise, pain, injury: 3%.
Adverse Events Reported from Other Clinical Trials: In addition, the following adverse drug reaction was reported in patients who participated in ITRACONAZOLE Capsules clinical trials: Hepatobiliary Disorders: hyperbilirubinemia.
The following is a list of additional adverse drug reactions associated with itraconazole that have been reported in clinical trials of ITRACONAZOLE Oral Solution and itraconazole IV excluding the adverse reaction term "Injection site inflammation" which is specific to the injection route of administration: Cardiac Disorders: cardiac failure, left ventricular failure, tachycardia.
General Disorders and Administration Site Conditions: face edema, chest pain, chills.
Hepatobiliary Disorders: hepatic failure, jaundice.
Investigations: alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, blood lactate dehydrogenase increased, blood urea increased, gamma-glutamyltransferase increased, urine analysis abnormal.
Metabolism and Nutrition Disorders: hyperglycemia, hyperkalemia, hypomagnesemia.
Psychiatric Disorders: confusional state.
Renal and Urinary Disorders: renal impairment.
Respiratory, Thoracic and Mediastinal Disorders: dysphonia, cough.
Skin and Subcutaneous Tissue Disorders: rash erythematous, hyperhidrosis.
Vascular Disorders: hypotension.