Itraconazole Side Effects

Brand Names: Sporanox

Please note - some side effects for Itraconazole may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Itraconazole - for the Consumer

Itraconazole

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Itraconazole:

Diarrhea; gas; headache; nausea; runny nose; stomach pain or upset; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloating; chest pain; confusion; dark urine; depression; fast or irregular heartbeat; fever; loss of appetite; numbness or tingling of the hands or feet; pain, redness, or swelling at the injection site; pale stools; red, swollen, blistered, or peeling skin; severe or persistent nausea; severe or persistent vomiting; shortness of breath; sudden weight gain; swelling of the hands, ankles, or feet; swollen or tender stomach; unusual bruising or bleeding; unusual tiredness or fatigue; yellowing of the skin or eyes.

Itraconazole Capsules

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Itraconazole Capsules:

Diarrhea; gas; headache; nausea; runny nose; stomach pain or upset; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloating; chest pain; confusion; dark urine; depression; fast or irregular heartbeat; fever; loss of appetite; numbness or tingling of the hands or feet; pale stools; red, swollen, blistered, or peeling skin; severe or persistent nausea; severe or persistent vomiting; shortness of breath; sudden weight gain; swelling of the hands, ankles, or feet; swollen or tender stomach; unusual bruising or bleeding; unusual tiredness or fatigue; yellowing of the skin or eyes.

Itraconazole Solution

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Itraconazole Solution:

Diarrhea; dizziness; gas; headache; nausea; runny nose; stomach pain or upset; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloating; chest pain; confusion; dark urine; depression; fast or irregular heartbeat; fever; loss of appetite; numbness or tingling of the hands or feet; pale stools; red, swollen, blistered, or peeling skin; severe or persistent nausea; severe or persistent vomiting; shortness of breath; sudden weight gain; swelling of the hands, ankles, or feet; swollen or tender abdomen; unusual tiredness or fatigue; yellowing of the skin or eyes.

Itraconazole Side Effects - for the Professional

Itraconazole

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.

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.

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.

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.

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%.

Post-Marketing Experience

Worldwide post-marketing experiences with the use of Itraconazole include very rare reports (<1/10,000) of the adverse events listed below:

There is limited information on the use of Itraconazole 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 has not been established.

Side Effects by Body System

General

In general, pooled data involving 15,000 patients suggest that adverse effects occur in approximately 7% of patients treated with itraconazole for 4 weeks or less, and up to 18% in patients treated for more than one month. Most reported adverse effects are transient and considered mild to moderate in nature.

Cardiovascular

Cardiovascular side effects have included hypertension (up to 3.2%), vein disorder (3%), hypotension (1%), orthostatic hypotension (1%), vasculitis (1%), and tachycardia (up to 1%). Premature ventricular contractions have been reported. Congestive heart failure has been reported during postmarketing experience.

Hepatic

Hepatic side effects have included bilirubinemia (up to 6%), abnormal liver function (up to 3%), increased SGPT/ALT (up to 3%), jaundice (up to 2%), increased SGOT/AST (up to 2%), increased gamma-glutamyltransferase (1% to 2%), and hepatitis (less than 2%). Mild, transient elevations in liver function tests have occurred in 1% to 7% of patients receiving continuous therapy. Rare cases of serious hepatotoxicity (including liver failure and death) and rare cases of reversible hepatitis (4 to 6 weeks after initiating itraconazole therapy) have been reported. Isolated cases of cholestatic jaundice have also been reported.

Gastrointestinal

Gastrointestinal side effects have included nausea (up to 11%), diarrhea (up to 11%), vomiting (7%), abdominal pain (up to 6%), dyspepsia (up to 4%), flatulence (up to 4%), gingivitis (3%), constipation (up to 3%), ulcerative stomatitis (up to 3%), gastritis (2%), increased appetite (2%), gastroenteritis (2%), dysphagia (less than 2%), hemorrhoids (less than 2%), dysgeusia (less than 2%), and anorexia (1%). Cholestasis and pancreatitis have been reported.

Hypersensitivity

Hypersensitivity side effects have included rash and pruritus in up to 5% of treated patients (may be more likely in immunocompromised patients). Anaphylaxis; anaphylactic, anaphylactoid, and allergic reactions; serum sickness; and angioneurotic edema have been reported during postmarketing experience. At least one case of anaphylactic shock following long-term intravenous therapy has been reported.

Metabolic

Metabolic side effects have included hypertriglyceridemia (up to 11%), hypokalemia (up to 9%), increased alkaline phosphatase (up to 2%), hypomagnesemia (up to 2%), increased lactate dehydrogenase (up to 2%), hypophosphatemia (1% to 2%), hyperglycemia (less than 2%), dehydration (less than 2%), decreased weight (less than 2%), fluid overload (1%), and hypocalcemia (1%).

Endocrine

Endocrine side effects have included adrenal insufficiency (less than 2%).

Nervous system

Nervous system side effects have included headache (up to 10%), dizziness (up to 4%), tremor (1% to 2%), insomnia (less than 2%), tinnitus (less than 2%), vertigo (1%), and somnolence (1%). An elderly patient experienced visual hallucinations, confusion, and weakness after receiving itraconazole. The symptoms reappeared following accidental itraconazole doses 7 and 10 days later. Transient or permanent hearing loss, peripheral neuropathy, paresthesia, and hypoesthesia have been reported during postmarketing experience.

Dermatologic

Dermatologic side effects have included rash (up to 9%), pruritus (up to 5%), increased sweating (up to 3%), unspecified skin disorder (2.3%), and erythematous rash (1% to 2%). Toxic epidermal necrolysis, Stevens-Johnson syndrome, exfoliative dermatitis, leukocytoclastic vasculitis, erythema multiforme, photosensitivity, urticaria, and alopecia have been reported during postmarketing experience.

Local

Local side effects associated with the intravenous formulation have included application site reaction (4%).

Renal

Renal side effects have included increased serum creatinine (up to 3%), abnormal renal function (1%), and increased blood urea nitrogen (up to 1%).

Hematologic

Hematologic side effects have included neutropenia, leukopenia, and thrombocytopenia during postmarketing experience.

Psychiatric

Psychiatric side effects have included depression (up to 3%), anxiety (3%), abnormal dreaming (2%), and decreased libido (up to 2%).

Respiratory

Respiratory side effects have included rhinitis (up to 9%), upper respiratory tract infection (up to 8%), sinusitis (up to 7%), coughing (4%), pneumonia (2%), increased sputum (2%), dyspnea (up to 2%), pharyngitis (up to 2%), and pulmonary infiltration (1% to 2%). Pulmonary edema has been reported during postmarketing experience.

Genitourinary

Genitourinary side effects have included cystitis (3%), urinary tract infection (3%), albuminuria (less than 2%), hematuria (less than 2%), gynecomastia (less than 2%), male breast pain (less than 2%), impotence (1%), and menstrual disorders (infrequent). Urinary incontinence and pollakiuria have been reported during postmarketing experience.

Musculoskeletal

Musculoskeletal side effects have included myalgia (up to 3%) and bursitis (3%). Arthralgia has been reported during postmarketing experience.

Other

Other side effects have included fever (up to 7%), injury (up to 7%), edema (up to 4%), chest pain (3%), fatigue (up to 3%), malaise (up to 3%), pain (up to 3%), asthenia (up to 2%), rigors (less than 2%), back pain (less than 2%), hot flushes (less than 2%), and implantation complication (less than 2%). Peripheral edema has been reported during postmarketing experience.

Ocular

Ocular side effects have included abnormal vision (less than 2%). Visual disturbances (including blurred vision and diplopia) have been reported during postmarketing experience.

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