Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
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 WARNINGS: Hepatic Effects and PRECAUTIONS: Hepatotoxicity and Information for Patients.) 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 who 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.
WARNINGS Hepatic Effects: Itraconazole have 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, and some of these cases developed within the first week of treatment.
If clinical signs or symptoms develop that are consistent with liver disease, treatment should be discontinued and liver function testing performed.
Continued itraconazole use or reinstitution of treatment with itraconazole is strongly discouraged unless there is a serious or life-threatening situation where the expected benefit exceeds the risk.
(See PRECAUTIONS: Information for Patients and ADVERSE REACTIONS.) Cardiac Dysrhythmias: Life-threatening cardiac dysrhythmias and/or sudden death have occurred in patients using drugs such as cisapride, pimozide, methadone, or quinidine concomitantly with itraconazole and/or other CYP3A4 inhibitors.
Like all medications, Itraconazole can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: