Medical Editor: John P. Cunha, DO, FACOEP
Sporanox (itraconazole) Injection is an antifungal agent used to treat a variety of fungal infections. The brand name Sporanox is discontinued, but generic versions may be available. Common side effects of Sporanox injection include:
- nausea,
- vomiting,
- diarrhea,
- rash,
- low blood potassium (hypokalemia),
- pain,
- headache, and
- injection site reactions
The recommended dose of Sporanox Injection is 200 mg twice daily for four doses, followed by 200 mg once daily for up to 14 days. Sporanox may interact with alfuzosin, benzodiazepines, statin drugs, conivaptan, eletriptan, eplerenone, ergot alkaloids, ivabradine, nisoldipine, ranolazine, vardenafil, calcium channel blockers, antibiotics, anti-seizure medicines, antiarrhythmics, chemotherapy drugs, immunosuppressants, HIV protease inhibitors, anti-diabetic drugs, halofantrine, alfentanil, fentanyl, solifenacin, buspirone, repaglinide, glucocorticosteroids, drugs for erectile dysfunction, trimetrexate, aripiprazole, trazodone, tolterodine, blood thinners, and cilostazol. Tell your doctor all medications and supplements you use. During pregnancy, Sporanox Injection should be used only if prescribed. This drug passes into breast milk. Consult your doctor before breastfeeding.
Our Sporanox (itraconazole) Injection 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.
SLIDESHOW
Fungal Skin Infections: Types, Symptoms, and Treatments See SlideshowGet 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 Injection (Itraconazole Injection)
QUESTION
Bowel regularity means a bowel movement every day. See AnswerSIDE EFFECTS
SPORANOX® (itraconazole injection) 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 INFORMATION FOR PATIENTS.)
Adverse Events Reported in Trials in Patients with SPORANOX® (itraconazole injection) 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® (itraconazole injection) 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® (itraconazole injection) 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® (itraconazole injection) Injection.
Table 2 Summary of Possibly or Definitely Drug-Related
Adverse Events Reported by ≥ 2% of Subjects
| Adverse Event | Total SPORANOX® Injection (N=360) % | Comparative Studies | ||
| SPORANOX Injection (N=234) % | Intravenous Fluconazole (N=32) % | Intravenous Amphotericin B (N=202) % | ||
| Gastrointestinal system disorders | ||||
| Nausea | 8 | 9 | 0 | 15 |
| Diarrhea | 6 | 6 | 3 | 9 |
| Vomiting | 4 | 6 | 0 | 10 |
| Abdominal pain | 2 | 2 | 0 | 3 |
| Constipation | 0 | 1 | 3 | 0 |
| Metabolic and nutritional disorders | ||||
| Hypokalemia | 5 | 8 | 0 | 29 |
| Alkaline phosphatase increased | 1 | 2 | 3 | 2 |
| Serum creatinine increased | 2 | 2 | 3 | 26 |
| Hypomagnesemia | 1 | 1 | 0 | 5 |
| Blood urea nitrogen increased | 0 | 1 | 0 | 7 |
| Fluid overload | 0 | 0 | 0 | 3 |
| Hypocalcemia | 0 | 0 | 0 | 3 |
| Liver and biliary system disorders | ||||
| Bilirubinemia | 4 | 6 | 9 | 3 |
| SGPT/ALT Increased | 2 | 3 | 3 | 1 |
| Hepatic function abnormal | 1 | 2 | 0 | 2 |
| Jaundice | 1 | 2 | 0 | 0 |
| SGOT/AST increased | 1 | 2 | 0 | 0 |
| Body as a whole – General disorders | ||||
| Pain | 1 | 2 | 0 | 0 |
| Rigors | 0 | 0 | 0 | 34 |
| Fever | 0 | 0 | 0 | 6 |
| Skin and appendages disorders | ||||
| Rash | 3 | 3 | 3 | 3 |
| Sweating increased | 1 | 2 | 0 | 0 |
| Respiratory system disorder | ||||
| Dyspnea | 0 | 0 | 0 | 3 |
| Central and peripheral nervous system disorders | ||||
| Dizziness | 1 | 2 | 0 | 1 |
| Headache | 2 | 2 | 0 | 3 |
| Urinary system disorders | ||||
| Renal function abnormal | 1 | 1 | 0 | 11 |
| Application site disorder | ||||
| Application site reaction | 4 | 0 | 0 | 0 |
| Cardiovascular disorders, general | ||||
| Hypotension | 0 | 0 | 0 | 3 |
| Hypertension | 0 | 0 | 0 | 2 |
| Heart rate and rhythm disorders | ||||
| Tachycardia | 0 | 1 | 0 | 3 |
| Vascular (extracardiac) disorders | ||||
| Vein disorder | 3 | 0 | 0 | 0 |
The following adverse events occurred in less than 2% of patients in clinical trials of SPORANOX® (itraconazole injection) Injection: LDH increased, edema, albuminuria, hyperglycemia, and hepatitis.
Post-marketing Experience
Adverse drug reactions that have been identified during post-approval use of SPORANOX® (itraconazole injection) (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.
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, hypokalemia |
| Nervous system disorders: | Peripheral neuropathy, paresthesia, hypoesthesia, headache, dizziness |
| Eye disorders: | Visual disturbances, including vision blurred and diplopia |
| Ear and labyrinth disorders: | Transient or permanent hearing loss, tinnitus |
| Cardiac disorders: | Congestive heart failure |
| Respiratory, thoracic and mediastinal | Pulmonary edema disorders: |
| Gastrointestinal disorders: | Abdominal pain, vomiting, dyspepsia, nausea, diarrhea, constipation, dysgeusia |
| Hepato-biliary 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, exfoliative dermatitis, leukocytoclastic vasculitis, erythemamultiforme, alopecia, photosensitivity, rash, urticaria, pruritus |
| Musculoskeletal and connective tissue disorders: | Myalgia, arthralgia |
| Renal and urinary disorders: | Urinary incontinence, pollakiuria |
| Reproductive system and breast disorders: | Menstrual disorders, erectile dysfunction |
| General disorders and administration site conditions: | Peripheral edema |
There is limited information on the use of SPORANOX® (itraconazole injection) 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 Injection (Itraconazole Injection)
© Sporanox Injection Patient Information is supplied by Cerner Multum, Inc. and Sporanox Injection Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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