Sporanox PulsePak Side Effects

Generic name: itraconazole

Please note - some side effects for Sporanox PulsePak 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 Sporanox PulsePak - for the consumer

Sporanox PulsePak

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 Sporanox PulsePak:

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloating; chest pain; confusion; dark urine; diarrhea; 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; shortness of breath; sudden weight gain; swelling of the hands, ankles, or feet; swollen or tender abdomen; unusual tiredness or fatigue; vomiting; yellowing of the skin or eyes.

By body system

General side effects

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 side effects

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 side effects

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 side effects

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 side effects

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 side effects

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 side effects

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

Nervous system side effects

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 side effects

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 side effects

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

Renal side effects

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

Hematologic side effects

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

Psychiatric side effects

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

Respiratory side effects

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 side effects

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 side effects

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

Other side effects

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 side effects

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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