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Sporanox

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Sporanox

Sporanox

Sporanox Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Sporanox (itraconazole) is used to treat infections caused by fungus, which can invade any part of the body including the lungs, mouth or throat, toenails, or fingernails. Sporanox is an antifungal agent. This medication is available in generic form. Common side effects include nausea/vomiting, diarrhea, gas, headache, dizziness, or stomach upset.

Dosage of Sporanox depends upon the condition for which it is being used to treat. Many drugs may interact with Sporanox, including blood thinners, cancer medications, cholesterol medications, cyclosporine, diabetes medication taken by mouth, antibiotics, antifungal medications, antidepressants, barbiturates, heart or blood pressure medications, HIV/AIDS medicine, sedatives, seizure medications, digoxin, disopyramide, fentanyl, isoniazid, rifabutin, rifampin, sirolimus, or tacrolimus. Tell your doctor all medications you are taking. During pregnancy, Sporanox should be used only when prescribed. It may harm a fetus. Discuss the risks with your doctor. It is recommended that men and women using this medication use two effective forms of birth control (e.g., condoms and birth control pills) while taking this medication and for 2 months after stopping it. Sporanox passes into breast milk. Consult your doctor before breast-feeding.

Our Sporanox 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 in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • fever;
  • feeling short of breath, even with mild exertion;
  • swelling, rapid weight gain;
  • problems with hearing;
  • numbness or tingly feeling;
  • 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.

Less serious side effects may include:

  • diarrhea, constipation, mild stomach pain;
  • mild itching or skin rash;
  • 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 (Itraconazole Capsules) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Sporanox Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning section.

Nausea/vomiting, diarrhea, gas, headache, dizziness, or stomach upset may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: signs of infection (e.g., fever, persistent sore throat), trouble breathing, unusual tiredness, swelling ankles/feet, burning/painful/frequent urination, decreased sexual interest/ability, hair loss, muscle cramps/pain, weakness, fast/irregular heartbeat, mental/mood changes (e.g., depression), enlarged breasts in men, ringing in the ears, temporary or permanent hearing loss.

Tell your doctor immediately if any of these rare but very serious side effects occur: numbness/tingling of the hands/feet.

Itraconazole has rarely caused very serious (possibly fatal) liver disease. If you notice any of the following highly unlikely but very serious side effects, stop taking itraconazole and tell your doctor immediately: yellowing eyes/skin, dark urine, persistent nausea/vomiting, stomach/abdominal pain.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Itraconazole can commonly cause a mild rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe allergic reaction. Therefore, seek immediate medical attention if you develop any rash.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Sporanox (Itraconazole Capsules)»

What is Prescribing information?

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

Sporanox FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

SPORANOX® (itraconazole capsules) 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 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.

Clinical Trials of Systemic Fungal Infections: Adverse Events Occurring with an Incidence of Greater than or Equal to 1%

Body System/Adverse Event Incidence (%)
(N=602)
Gastrointestinal
  Nausea 11
  Vomiting 5
  Diarrhea 3
  Abdominal Pain 2
  Anorexia 1
Body as a Whole
  Edema 4
  Fatigue 3
  Fever 3
  Malaise 1
Skin and Appendages
  Rash* 9
  Pruritus 3
Central/Peripheral Nervous System
  Headache 4
  Dizziness 2
Psychiatric
  Libido Decreased 1
  Somnolence 1
Cardiovascular
  Hypertension 3
Metabolic/Nutritional
  Hypokalemia 2
Urinary System
  Albuminuria 1
Liver and Biliary System
  Hepatic Function Abnormal 3
Reproductive System, Male
  Impotence 1
* Rash tends to occur more frequently in immunocompromised patients receiving immunosuppressive medications.

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.

Clinical Trials of Onychomycosis of the Toenail: Adverse Events Leading to Temporary or Permanent Discontinuation of Theranv

Adverse Event Incidence (%)
Itraconazole
(N=112)
Elevated Liver Enzymes (greater than twice the upper limit of 4
normal)  
Gastrointestinal Disorders 4
Rash 3
Hypertension 2
Orthostatic Hypotension 1
Headache 1
Malaise 1
Myalgia 1
Vasculitis 1
Vertigo 1

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.

Clinical Trials of Onychomycosis of the Fingernail: Adverse Events Leading to Temporary or Permanent Discontinuation of Therapv

Adverse Event Incidence (%)
Itraconazole
(N=37)
Rash/Pruritus 3
Hypertriglyceridemia 3

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

Adverse drug reactions that have been identified during post-approval use of SPORANOX® (itraconazole capsules) (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; anaphy lactic, 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 disorder: Transient or permanent hearing loss, tinnitus
Cardiac disorders: Congestive heart failure
Respiratory, thoracic and mediastinal disorders: Pulmonary edema
Gastrointestinal disorders: Pancreatitis, 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, erythema multiforme, 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, pyrexia

There is limited information on the use of SPORANOX® (itraconazole capsules) 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 (Itraconazole Capsules) »

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Sporanox - User Reviews

Sporanox User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Sporanox sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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