annot be directly compared to rates in the clinical trialsof another drug and may not reflect the rates observed in clinical practice.
Adverse Reactions in the Treatment of Systemic Fungal InfectionsSafety 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 concomitantmedications. Treatment was discontinued in 10.5% of patients due to adverse events. The medianduration before discontinuation of therapy was 81 days (range: 2 to 776 days). Table 2 listsadverse reactions reported by at least 1% of patients.
Table 2: Clinical Trials of Systemic Fungal Infections: Adverse Reactions Occurring
with an Incidence of ≥1%
Body System/Adverse Reaction Incidence (%) (N=602)
Gastrointestinal
Nausea
Vomiting
Diarrhea
Abdominal Pain
Anorexia
11
5
3
2
1
Body as a Whole
Edema
Fatigue
Fever
Malaise
4
3
3
1
Skin and Appendages
Rash*
Pruritus
9
3
Central/Peripheral Nervous System
Headache
Dizziness
4
2
Psychiatric
Libido Decreased
Somnolence
1
1
Cardiovascular
Hypertension 3
Metabolic/Nutritional
Hypokalemia 2
Urinary System
Albuminuria 1
Liver and Biliary System
Hepatic Function Abnormal 3
Reproductive System, Male
Impotence 1
* Rash tends to occur more frequently in immunocompromised patients receiving immunosuppressive medications.
Adverse reactions reported at a rate of <1% included: constipation, gastritis, depression,insomnia, tinnitus, menstrual disorder, adrenal insufficiency, gynecomastia, and male breastpain.
Adverse Reactions Reported from Other Clinical TrialsIn 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, bloodalkaline 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
6.2 Postmarketing Experience
Adverse reactions that have been identified during post-marketing experience with itraconazoleare listed in Table 3. Because these reactions are reported voluntarily from a population ofuncertain size, reliably estimating their frequency or establishing a causal relationship to drugexposure is not always possible.
Table 3: Postmarketing Reports of Adverse Drug Reactions
Blood and Lymphatic System Disorders: Leukopenia, neutropenia, thrombocytopeniaImmune System Disorders: Anaphylaxis; anaphylactic, anaphylactoid and allergic
reactions; serum sickness; angioneurotic edemaNervous System |
