Itraconazole (Page 7 of 9)

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.

Table 4: Clinical Trials of Onychomycosis of the Toenail: Adverse Events Leading to Temporary or Permanent Discontinuation of Therapy

Adverse Event

Incidence (%)

Itraconazole (N = 112)

Elevated Liver Enzymes (greater than twice the upper limit of normal)

4

Gastrointestinal Disorders

4

Rash

3

Hypertension

2

Orthostatic Hypotension

1

Headache

1

Malaise

1

Myalgia

1

Vasculitis

1

Vertigo

1

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 dosing 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.

Table 5: Clinical Trials of Onychomycosis of the Fingernail: Adverse Events Leading to Temporary or Permanent Discontinuation of Therapy

Adverse Event

Incidence (%)

Itraconazole (N = 37)

Rash/Pruritus

3

Hypertriglyceridemia

3

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 capsule 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

Post-marketing Experience

Adverse drug reactions that have been first identified during post-marketing experience with itraconazole (all formulations) are listed in the table below. 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 6: Post-marketing Reports of Adverse Drug Reactions

Blood and Lymphatic System Disorders:

Leukopenia, neutropenia, thrombocytopenia

Immune System Disorders:

Anaphylaxis; anaphylactic, anaphylactoid and allergic reactions; serum sickness; angioneurotic edema

Nervous System Disorders:

Peripheral neuropathy, paresthesia, hypoesthesia, tremor

Eye Disorders:

Visual disturbances, including vision blurred and diplopia

Ear and Labyrinth Disorders:

Transient or permanent hearing loss

Cardiac Disorders:

Congestive heart failure

Respiratory, Thoracic and Mediastinal Disorders:

Pulmonary edema, dyspnea

Gastrointestinal Disorders:

Pancreatitis, dysgeusia

Hepatobiliary Disorders:

Serious hepatotoxicity (including some cases of fatal acute liver failure), hepatitis

Skin and Subcutaneous Tissue Disorders:

Toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, erythema multiforme, exfoliative dermatitis, leukocytoclastic vasculitis, alopecia, photosensitivity, urticaria

Musculoskeletal and Connective Tissue Disorders:

Arthralgia

Renal and Urinary Disorders:

Urinary incontinence, pollakiuria

Reproductive System and Breast Disorders:

Erectile dysfunction

General Disorders and Administration Site Conditions:

Peripheral edema

Investigations:

Blood creatine phosphokinase increased

There is limited information on the use of itraconazole capsules during pregnancy. Cases of congenital abnormalities including skeletal, genitourinary tract, cardiovascular and ophthalmic malformations as well as chromosomal and multiple malformations have been reported during post-marketing experience. A causal relationship with itraconazole capsules has not been established. (See CLINICAL PHARMACOLOGY: Special Populations, CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS: Drug Interactions for more information.)

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2021. All Rights Reserved.