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.

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.

Side Effects by Body System - for Healthcare Professionals

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.

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 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 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 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, exfoliative dermatitis, leukocytoclastic vasculitis, erythema multiforme, photosensitivity, rash, urticaria, 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 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.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.