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Sporanox Oral Solution

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Sporanox Oral Solution

Sporanox Oral Solution Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Sporanox (itraconazole) Oral Solution is an antifungal medication used to treat infections caused by fungus, which can invade any part of the body including the lungs, mouth or throat, toenails, or fingernails. Common side effects include diarrhea, constipation, stomach pain, itching or skin rash, headache, dizziness, runny nose or other cold symptoms.

The recommended dosage of Sporanox Oral Solution for oropharyngeal candidiasis is 200 mg (20 mL) daily for 1 to 2 weeks. Sporanox may interact with blood thinners, cancer medications, cholesterol medications, cyclosporine, oral diabetes medications, digoxin, disopyramide, fentanyl, isoniazid, rifabutin, rifampin, rifapentine, sirolimus or tacrolimus, antibiotics, antifungals, antidepressants, barbiturates, heart or blood pressure medications, HIV/AIDS medicines, sedatives, or seizure medications. Tell your doctor all medications and supplements you use. During pregnancy, Sporanox should be used only if prescribed. This drug passes into breast milk and can harm a nursing baby. Consult your doctor before breastfeeding.

Our Sporanox (itraconazole) Oral Solution Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Sporanox Oral Solution in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: 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. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Sporanox Oral Solution (Itraconazole Oral Solution) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Sporanox Oral Solution FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

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. (See WARNINGS: Hepatic Effects and PRECAUTIONS: Hepatotoxicity and PATIENT INFORMATION .)

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 2 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.

Table 2: Summary of Adverse Events Reported by ≥ 2% of SPORANOX® Treated Patients in U.S. Clinical Trials (Total)

Body System/ Adverse Event Itraconazole Fluconazole
(n = 125†) %
Clotrimazole
(n = 81‡) %
Total
(n = 350*) %
Allcontrolled studies
(n = 272) %
Gastrointestinal disorders
  Nausea 11 10 11 5
  Diarrhea 11 10 10 4
  Vomiting 7 6 8 1
  Abdominal pain 6 4 7 7
  Constipation 2 2 1 0
Body as a whole
  Fever 7 6 8 5
  Chest pain 3 3 2 0
  Pain 2 2 4 0
  Fatigue 2 1 2 0
Respiratory disorders
  Coughing 4 4 10 0
  Dyspnea 2 3 5 1
  Pneumonia 2 2 0 0
  Sinusitis 2 2 4 0
  Sputum increased 2 3 3 1
Skin and appendages disorders
  Rash 4 5 4 6
  Increased sweating 3 4 6 1
  Skin disorder unspecified 2 2 2 1
Central/peripheral nervous system
  Headache 4 4 6 6
  Dizziness 2 2 4 1
Resistance mechanism disorders
  Pneumocystis carinii infection 2 2 2 0
Psychiatric disorders
  Depression 2 1 0 1
* Of the 350 patients, 209 were treated for oropharyngeal candidiasis in controlled studies, 63 were treated for esophageal candidiasis in controlled studies and 78 were treated for oropharyngeal candidiasis in an open study.
† Of the 125 patients, 62 were treated for oropharyngeal candidiasis and 63 were treated for esophageal candidiasis.
‡ All 81 patients were treated for oropharyngeal candidiasis.

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.

Adverse Events Reported From Other Clinical Trials

A comparative clinical trial in patients who received intravenous itraconazole followed by SPORANOX® Oral Solution or received Amphotericin B reported the following adverse events in the itraconazole intravenous/SPORANOX® Oral Solution treatment arm which are not listed above in the subsection “Adverse Events Reported in Oropharnyngeal or Esophageal Candidiasis Trials” or listed below as postmarketing reports of adverse drug reactions: serum creatinine increased, blood urea nitrogen increased, renal function abnormal, hypocalcemia, hypomagnesemia, hypophosphatemia, hypotension, tachycardia, tremor, and pulmonary infiltration.

In addition, the following adverse drug reactions were reported in patients who participated in SPORANOX® Oral Solution clinical trials:

Cardiac Disorders: cardiac failure;

General Disorders and Administration Site Conditions: edema;

Hepatobiliary Disorders: hepatic failure, hyperbilirubinemia;

Metabolism and Nutrition Disorders: hypokalemia;

Reproductive System and Breast Disorders: menstrual disorder

The following is a list of additional adverse drug reactions associated with itraconazole that have been reported in clinical trials of SPORANOX® Capsules and itraconazole IV excluding the adverse reaction term “Injection site inflammation” which is specific to the injection route of administration:

Cardiac Disorders: left ventricular failure;

Gastrointestinal Disorders: gastrointestinal disorder;

General Disorders and Administration Site Conditions: face edema;

Hepatobiliary Disorders: jaundice, hepatic function abnormal;

Investigations: alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, blood lactate dehydrogenase increased, gammaglutamyltransferase increased, urine analysis abnormal;

Metabolism and Nutrition Disorders: hyperglycemia, hyperkalemia;

Nervous System Disorders: somnolence;

Psychiatric Disorders: confusional state;

Renal and Urinary Disorders: renal impairment;

Respiratory, Thoracic and Mediastinal Disorders: dysphonia;

Skin and Subcutaneous Tissue Disorders: rash erythematous;

Vascular Disorders: hypertension

In addition, the following adverse drug reaction was reported in children only who participated in SPORANOX® Oral Solution clinical trials: mucosal inflammation.

Post-marketing Experience

Adverse drug reactions that have been first identified during post-marketing experience with SPORANOX® (all formulations) are listed in the table below. Because these reactions are reported voluntarily from a population of uncertain size, reliably estimating their frequency or establishing a causal relationship to drug exposure is not always possible.

Table 3: Postmarketing Reports of Adverse Drug Reactions

Blood and Lymphatic System Disorders: Leukopenia, neutropenia, thrombocytopenia
Immune System Disorders: Anaphylaxis; anaphylactic, anaphylactoid and allergic reactions; serum sickness; angioneurotic edema
Metabolism and Nutrition Disorders: Hypertriglyceridemia
Nervous System Disorders: Peripheral neuropathy, paresthesia, hypoesthesia
Eye Disorders: Visual disturbances, including vision blurred and diplopia
Ear and Labyrinth Disorders: Transient or permanent hearing loss
Cardiac Disorders: Congestive heart failure
Respiratory, Thoracic and Mediastinal Disorders: Pulmonary edema
Gastrointestinal Disorders: Pancreatitis
Hepatobiliary Disorders: Serious hepatotoxicity (including some cases of fatal acute liver failure), hepatitis, reversible increases in hepatic enzymes
Skin and Subcutaneous Tissue Disorders: Toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, erythema multiforme, exfoliative dermatitis, leukocytoclastic vasculitis, alopecia, photosensitivity, urticaria
Musculoskeletal and Connective Tissue Disorders: Arthralgia
Renal and Urinary Disorders: Urinary incontinence, pollakiuria
Reproductive System and Breast Disorders: Erectile dysfunction
General Disorders and Administration Site Conditions: Peripheral edema
Investigations: Blood creatine phosphokinase increased

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. (See CLINICAL PHARMACOLOGY: Special Populations, CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS: DRUG INTERACTIONS for more information.)

Read the entire FDA prescribing information for Sporanox Oral Solution (Itraconazole Oral Solution) »

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