Sporanox Oral Solution
- Generic Name: itraconazole oral solution
- Brand Name: Sporanox Oral Solution
Sporanox Oral Solution(Itraconazole Oral Solution) side effects drug center
Sporanox Oral Solution Side Effects Center
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 of Sporanox Oral Solution include:
- diarrhea,
- constipation,
- bloating,
- nausea,
- stomach pain,
- unpleasant taste in your mouth,
- itching or skin rash,
- joint pain,
- muscle pain,
- weakness,
- 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.
Sporanox Oral Solution Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives, severe skin rash, tingling in your arms or legs; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using itraconazole and call your doctor at once if you have signs of congestive heart failure: feeling tired or short of breath, cough with mucus, fast heartbeats, swelling, rapid weight gain, or sleep problems.
Keep taking itraconazole but call your doctor at once if you have:
- confusion, a light-headed feeling (like you might pass out);
- blurred vision, double vision, ringing in your ears, problems with hearing;
- fast heartbeats;
- numbness or tingly feeling, loss of bladder control;
- little or no urinating, pain or burning when you urinate;
- low potassium level--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, muscle weakness or limp feeling;
- pancreatitis--severe pain in your upper stomach spreading to your back, nausea and vomiting; or
- liver problems--nausea, upper stomach pain, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Common side effects may include:
- headache, dizziness, drowsiness, tiredness;
- increased blood pressure;
- rash, itching;
- nausea, vomiting, stomach pain, diarrhea, constipation;
- swelling;
- abnormal liver function or blood tests;
- fever, muscle or joint pain;
- unusual or unpleasant taste in your mouth;
- hair loss;
- impotence, erection problems; or
- changes in your menstrual periods.
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)
Sporanox Oral Solution Professional Information
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)
&Copy; Sporanox Oral Solution Patient Information is supplied by Cerner Multum, Inc. and Sporanox Oral Solution Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.