Sporanox Side Effects

Generic Name: Itraconazole

Please note - some side effects for Sporanox 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 - 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.

Sporanox

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:

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.

Sporanox 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 Sporanox Capsules:

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.

Sporanox 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 Sporanox 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.

For the professional

Sporanox

Sporanox® 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 Sporanox® use should be reassessed.

Adverse Events Reported in Empiric Therapy in Febrile Neutropenic (ETFN) Patients

Adverse events considered at least possibly drug related in a clinical trial of empiric therapy in 384 febrile, neutropenic patients (192 treated with Sporanox® and 192 ith amphotericin B) with suspected fungal infections are listed in Table 2 below. Patients received a regimen of Sporanox® Injection followed by Sporanox® Oral Solution. The dose of Sporanox® Injection was 200 mg twice daily for the first two days followed by a single daily dose of 200 mg for the remainder of the intravenous treatment period. The majority of patients received between 7 and 14 days of Sporanox® Injection. The dose of Sporanox® Oral Solution was 200 mg (20 mL) b.i.d. for the remainder of therapy.

The following additional adverse events considered at least possibly related occurred in between 1 and 2% of patients who received Sporanox® Injection and Oral Solution: constipation, hypophosphatemia, gamma-GT increased, erythematous rash, pruritus, dizziness, tremor, and pulmonary infiltration.

Adverse Events Reported in Oropharyngeal or Esophageal Candidiasis Trials

U.S. adverse experience data are derived from 350 immunocompromised patients (332 HIV seropositive/AIDS) treated for oropharyngeal or esophageal candidiasis. Table 3 below lists adverse events reported by at least 2% of patients treated with Sporanox® Oral Solution in U.S. clinical trials. Data on patients receiving comparator agents in these trials are included for comparison.

Treated Patients in U.S. Clinical Trials (Total)

Adverse events reported by less than 2% of patients in U.S. clinical trials with Sporanox® included: adrenal insufficiency, asthenia, back pain, dehydration, dyspepsia, dysphagia, flatulence, gynecomastia, hematuria, hemorrhoids, hot flushes, implantation complication, infection unspecified, injury, insomnia, male breast pain, myalgia, pharyngitis, pruritus, rhinitis, rigors, stomatitis ulcerative, taste perversion, tinnitus, upper respiratory tract infection, vision abnormal, and weight decrease. Edema, hypokalemia and menstrual disorders have been reported in clinical trials with itraconazole capsules.

Post-marketing Experience

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

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

Sporanox Capsules

Sporanox® 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 Sporanox® 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 Sporanox® include adverse events of gastrointestinal origin, such as dyspepsia, nausea, vomiting, diarrhea, abdominal pain and constipation. Other reported adverse events include peripheral edema, congestive heart failure and pulmonary edema, headache, dizziness, peripheral neuropathy, menstrual disorders, reversible increases in hepatic enzymes, hepatitis, liver failure, hypokalemia, hypertriglyceridemia, alopecia, allergic reactions (such as pruritus, rash, urticaria, angioedema, anaphylaxis), Stevens-Johnson syndrome, anaphylactic, anaphylactoid and allergic reactions, photosensitivity and neutropenia. There is limited information on the use of Sporanox® 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 Sporanox® has not been established..

Sporanox Injection

Sporanox® 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 Sporanox® use should be reassessed.

Adverse Events Reported in Trials in Patients with Sporanox® Injection

Adverse events considered at least possibly drug related are shown in Table 2 and are based on the experience of 360 patients treated with Sporanox® Injection in four pharmacokinetic, one uncontrolled and four active controlled studies where the control was amphotericin B or fluconazole. Nearly all patients were neutropenic or were otherwise immunocompromised and were treated empirically for febrile episodes, for documented systemic fungal infections, or in trials to determine pharmacokinetics. The dose of Sporanox® Injection was 200 mg twice daily for the first two days followed by a single daily dose of 200 mg for the remainder of the intravenous treatment period. The majority of patients received between 7 and 14 days of Sporanox® Injection.

The following adverse events occurred in less than 2% of patients in clinical trials of Sporanox® Injection: LDH increased, edema, albuminuria, hyperglycemia, and hepatitis.

Post-marketing Experience

Worldwide post-marketing experiences with the use of Sporanox® include adverse events of gastrointestinal origin, such as dyspepsia, nausea, vomiting, diarrhea, abdominal pain and constipation. Other reported adverse events include peripheral edema, congestive heart failure and pulmonary edema, headache, dizziness, peripheral neuropathy, menstrual disorders, reversible increases in hepatic enzymes, hepatitis, liver failure, hypokalemia, hypertriglyceridemia, alopecia, allergic reactions (such as pruritus, rash, urticaria, angioedema, anaphylaxis), Stevens-Johnson syndrome, anaphylactic, anaphylactoid and allergic reactions, photosensitivity and neutropenia. There is limited information on the use of Sporanox® 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 Sporanox® has not been established.

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