Sporanox Side Effects

Generic name: itraconazole

Note: This document contains side effect information about itraconazole. Some of the dosage forms listed on this page may not apply to the brand name Sporanox.

Some side effects of Sporanox may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to itraconazole: oral capsule, oral solution, oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking itraconazole (the active ingredient contained in Sporanox) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• fever;

• feeling short of breath, even with mild exertion;

• swelling, rapid weight gain;

• ringing in your ears, problems with hearing;

• numbness or tingly feeling, blurred vision, double vision, loss of bladder control;

• pain or burning when you urinate;

• nausea, pain in your upper stomach, itching, loss of appetite, weakness, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate.

Other common side effects may include:

• diarrhea, constipation, bloating, mild nausea;

• unpleasant taste in your mouth;

• mild itching or skin rash;

• joint pain, muscle pain or weakness;

• headache, dizziness; or

• runny nose or other cold symptoms.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to itraconazole: intravenous kit, oral capsule, oral solution, oral tablet

General

In general, pooled data involving 15,000 patients suggest that adverse effects occur in approximately 7% of patients treated with itraconazole (the active ingredient contained in Sporanox) 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.

Gastrointestinal

Gastrointestinal side effects have included nausea (up to 11%), diarrhea (up to 11%), vomiting (7%), abdominal pain or discomfort (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 has been reported. Abdominal pain, pancreatitis, vomiting, dyspepsia, nausea, diarrhea, constipation, and dysgeusia have also been reported during postmarketing experience.

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%). Hypertriglyceridemia and hypokalemia have also been reported during postmarketing experience.

Nervous system

Nervous system side effects have included headache (up to 10%), dizziness (up to 4%), hypoacusis (3.3%), 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 active ingredient contained in Sporanox) The symptoms reappeared following accidental itraconazole doses 7 and 10 days later. Transient or permanent hearing loss, tinnitus, peripheral neuropathy, paresthesia, headache, dizziness, and hypoesthesia have been reported during postmarketing experience.

Respiratory

Respiratory side effects have included rhinitis (up to 9%), upper respiratory tract infection (up to 8%), sinusitis (up to 7%), coughing (up to 4%), pneumonia (2%), increased sputum (2%), dyspnea (up to 2%), pharyngitis (up to 2%), pulmonary infiltration (1% to 2%), and pharyngolaryngeal pain (1%). Pulmonary edema and dyspnea have 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 and pyrexia 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, acute generalized exanthematous pustulosis, exfoliative dermatitis, leukocytoclastic vasculitis, erythema multiforme, photosensitivity, rash, urticaria, pruritus, and alopecia have 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 (the active ingredient contained in Sporanox) therapy) have been reported. Isolated cases of cholestatic jaundice have also been reported. Serious hepatotoxicity (including some cases of fatal acute liver failure), hepatitis, and reversible increases in hepatic enzymes have also been reported during postmarketing experience.

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.

Cardiovascular

Cardiovascular side effects have included hypertension (up to 3.2%), vein disorder (3%), abnormal electrocardiogram (1.4%), hypotension (1%), orthostatic hypotension (1%), vasculitis (1%), sinus bradycardia (1%), and tachycardia (up to 1%). Premature ventricular contractions have been reported. Congestive heart failure has 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%).

Psychiatric

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

Genitourinary

Genitourinary side effects have included cystitis (3%), urinary tract infection (up to 3%), albuminuria (less than 2%), hematuria (less than 2%), gynecomastia (less than 2%), male breast pain (less than 2%), bacteriuria (1.4%), impotence (1%), and menstrual disorders (infrequent). Urinary incontinence, pollakiuria, menstrual disorders, and erectile dysfunction have been reported during postmarketing experience.

Musculoskeletal

Musculoskeletal side effects have included myalgia (up to 3%), bursitis (3%), and back pain (1.2%). Arthralgia and myalgia have been reported during postmarketing experience.

Hematologic

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

Immunologic

Immunologic side effects have included Pneumocystis carinii infection (2%), herpes zoster (2%), and unspecified infection (less than 2%).

Endocrine

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

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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