TOLSURA SIDE EFFECTS

SIDE EFFECTS

The following clinically significant adverse reactions are described elsewhere in the labeling:

• Congestive Heart Failure
• Hepatotoxicity
• Cardiac Dysrhythmias
• Peripheral Neuropathy
• Hearing Loss
• Hypersensitivity Reactions

Clinical Trials Experience

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.

Adverse Reactions In The Treatment Of Systemic Fungal Infections

Safety data with itraconazole capsules 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). Table 1 lists adverse reactions reported by at least 1% of patients.

Table 1: Clinical Trials of Systemic Fungal Infections: Adverse Reactions Occurring with an Incidence of ≥1%

Adverse reactions reported at a rate of <1% included: constipation, gastritis, depression, insomnia, tinnitus, menstrual disorder, adrenal insufficiency, gynecomastia, and male breast pain.

Adverse Reactions Reported From Other Clinical Trials

In addition, the following adverse reactions were reported in itraconazole-treated patients who participated in clinical trials:

Hepatobiliary Disorders: hyperbilirubinemia;

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, gammaglutamyltransferase 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: hyperhidrosis;

Vascular Disorders: hypotension

Postmarketing Experience

Adverse reactions that have been identified during post-marketing experience with itraconazole are listed in Table 2. Because these reactions are reported voluntarily from a population of uncertain size, reliably estimating their frequency or establishing a causal relationship to drug exposure is not always possible.

Table 2: Postmarketing Reports of Adverse Drug Reactions