Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Sporanox. If you are concerned about side effects, discuss the risks and benefits of Sporanox with your doctor.

The following side effects have been reported by at least 1% of people taking Sporanox. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• abdominal pain
• bloating
• Constipation
• cough
• Diarrhea
• dizziness
• drowsiness
• gas
• headache
• increased sensitivity to sunlight
• nausea
• skin rash
• sweating
• unpleasant taste in the mouth
• voice changes
• vomiting

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• blurred vision
• confusion
• decreased hearing
• Fever and chills
• joint pain
• loss of ability to control urine or urinating much more than usual
• muscle weakness or pain
• numbness
• "pins and needles" feeling
• reduced sense of touch
• ringing in the ears
• signs of heart problems (e.g., fast, irregular heartbeat or pulse, chest pain, sudden weight gain, difficulty breathing, leg swelling)
• signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools, skin rash and itching)
• tremor

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)
• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
• signs of a severe skin reaction such as reddening, blistering, peeling, or loosening of skin and mucous membranes

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Sporanox.

Each pink and blue capsule, imprinted in white with "JANSSEN" on the cap and "SPORANOX" over "100" on the body, contains 100 mg of itraconazole in a pellet formulation. Nonmedicinal ingredients: D&C Red No. 22, D&C Red No. 28, FD&C Blue No. 1, FD&C Blue No. 2, gelatin, hydroxypropyl methylcellulose, polyethylene glycol, sugar spheres (NF), and titanium dioxide.

Do not take itraconazole if you:

• are allergic to itraconazole or any ingredients of the medication
• are allergic to other "azole" antifungals such as ketoconazole
• are taking the following medications: including dofetilide, Pimozide, quinidine, Lovastatin, Simvastatin, Triazolam, midazolam (when taken by mouth), ergot alkaloids (such as Dihydroergotamine, ergonovine, ergotamine), Eletriptan, and nisoldipine
• asunaprevir (boosted)
• Disopyramide
• Domperidone
• Dronedarone
• Eplerenone
• ergot alkaloids (such as dihydroergotamine, ergonovine, ergotamine)
• Irinotecan
• Lomitapide
• lovastatin
• Lurasidone
• Methadone
• Naloxegol
• pimozide
• quinidine
• simvastatin
• Ticagrelor
• triazolam
• have a history of heart failure (including Congestive Heart Failure) – itraconazole may be used to treat other more serious types of fungal infections in people who have or have had heart failure when the benefit of treatment clearly outweighs the risk.

Women who are pregnant or planning to become pregnant should not take itraconazole to treat onychomycosis (fungal nail infections) or dermatomycoses (fungal skin infections such as tinea corporis [ringworm], Tinea Cruris (Jock Itch) [jock itch], tinea pedis [Athlete's Foot], pityriasis versicolor).

There may be an interaction between itraconazole and any of the following:

• Abiraterone
• Aliskiren
• alpha blockers (e.g., Alfuzosin, Doxazosin, Silodosin, Tamsulosin)
• Amiodarone
• antacids (e.g., aluminum hydroxide, calcium carbonate, magnesium hydroxide)
• anti-cancer medications (e.g., Cabazitaxel, Docetaxel, Doxorubicin, Etoposide, Ifosfamide, irinotecan, Trastuzumab, Vincristine)
• anti-psychotics (e.g., Chlorpromazine, Clozapine, Haloperidol, Olanzapine, Quetiapine, Risperidone)
• Apixaban
• Aprepitant
• Aripiprazole
• "azole" antifungals (e.g., itraconazole, ketoconazole, Voriconazole)
• benzodiazepines (e.g., Alprazolam, Chlordiazepoxide, Clonazepam, Clorazepate, Diazepam, Flurazepam, midazolam)
• Bicalutamide
• birth control pills
• Bosentan
• Buprenorphine
• Calcitriol
• calcium channel blockers (e.g., Amlodipine, Diltiazem, Nifedipine, verapamil)
• Carvedilol
• chloroquine
• Colchicine
• conivaptan
• inhaled corticosteroids (e.g., budesonide, ciclesonide, fluticasone)
• nasal corticosteroids (e.g., budesonide, fluticasone)
• oral corticosteroids (e.g., Dexamethasone, Hydrocortisone, Prednisone)
• Cyclosporine
• dabigatran
• Dantrolene
• Dapsone
• Degarelix
• didanosine
• Digoxin
• disopyramide
• dofetilide
• domperidone
• dronedarone
• Edoxaban
• eplerenone
• ergot alkaloids (e.g., dihydroergotamine, ergonovine, ergotamine)
• estrogens (e.g., conjugated estrogen, Estradiol, ethinyl estradiol)
• Everolimus
• Flecainide
• Flutamide
• "gliptin" diabetes medications (e.g., Linagliptin, Saxagliptin, Sitagliptin)
• grapefruit juice
• Guanfacine
• H2-receptor antagonists (e.g., Cimetidine, Famotidine, Nizatidine, ranitidine)
• Hepatitis C antivirals (e.g., asunaprevir, daclatasvir, grazoprevirsimeprevir, sofosbuvir)
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delavirdine, efavirenz, etravirine, nevirapine)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• isoniazid
• Ivabradine
• lidocaine
• Loperamide
• Losartan
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• maraviroc
• Mefloquine
• methadone
• Metronidazole
• mifepristone
• Mirtazapine
• Modafinil
• Montelukast
• Nadolol
• narcotic pain relievers (e.g., Codeine, Fentanyl, Morphine, Oxycodone)
• nefazodone
• nitrates (e.g., isosorbide dinitrate, isosorbide mononitrate)
• Ondansetron
• oxycodone
• pentamidine
• Phenobarbital
• phosphodiesterase-5 inhibitors (e.g., Sildenafil, Tadalafil, Vardenafil)
• Prasugrel
• praziquantel
• procainamide
• progestins (e.g., Dienogest, Levonorgestrel, medroxyprogesterone, Norethindrone)
• proton pump inhibitors (e.g., omeprazole, Esomeprazole, Lansoprazole)
• quinidine
• quinine
• quinolone antibiotics (e.g., ciprofloxacin, Norfloxacin, Ofloxacin)
• Repaglinide
• rifabutin
• rifampin
• rifapentine
• rilpivirine
• Rivaroxaban
• Romidepsin
• St. John's wort
• saccharomyces boulardii
• salmeterol
• seizure medications (e.g., Carbamazepine, Clobazam, Levetiracetam, phenobarbital, Phenytoin, primidone, Topiramate, Valproic acid, zonisamide)
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Fluoxetine, Paroxetine, Sertraline)
• serotonin antagonists (anti-emetic medications; e.g., Granisetron, ondansetron, Palonosetron)
• Sirolimus
• Solifenacin
• Sotalol
• "statin" anti-cholesterol medications (e.g., Atorvastatin, lovastatin, simvastatin)
• sulcrafate
• Tacrolimus
• Tamoxifen
• Tetrabenazine
• Tetracycline
• Theophylline
• ticagrelor
• Ticlopidine
• Tolterodine
• Tolvaptan
• Tramadol
• Trazodone
• tricyclic antidepressants (e.g., Amitriptyline, Clomipramine, Desipramine, Trimipramine)
• Trimethoprim
• "triptan" migraine medications (e.g., eletriptan, Sumatriptan)
• tyrosine kinase inhibitors (e.g., Bosutinib, Dasatinib, imatinib, Nilotinib)
• Ulipristal
• Venlafaxine
• Warfarin
• Zolpidem
• Zopiclone

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Sporanox. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Sporanox.

Abnormal heart rhythms: Sporanox can cause abnormal heart rhythms. Certain medications (e.g., cisapride, methadone, pimozide, or quinidine) can increase the risk of a type of abnormal heart rhythm called QT prolongation, and should not be used in combination with itraconazole. You are more at risk for this type of abnormal heart rhythm and its complications if you:

• are female
• are older than 65 years of age
• have a family history of sudden cardiac death
• have a history of heart disease or abnormal heart rhythms
• have a slow heart rate
• have congenital prolongation of the QT interval
• have Diabetes
• have had a Stroke
• have low potassium, magnesium, or calcium levels
• have nutritional deficiencies

If you have heart disease and abnormal heart rhythms, or people are taking certain medications (e.g., Verapamil, atazanavir), discuss with your doctor how Sporanox may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Sporanox, and whether any special monitoring is needed.

Capsules and solution: Itraconazole capsules and oral solution should not be used interchangeably. When the same dose of medication is given, the exposure to the itraconazole is greater with the oral solution than with the capsules.

Decreased stomach acidity: Less itraconazole is absorbed into the body when stomach acidity is decreased. For people also taking antacids (e.g., aluminum hydroxide), these should be taken at least 2 hours after itraconazole. In people with achlorhydria (decreased stomach acidity), such as certain AIDS patients or people on acid secretion suppressors (e.g., H2-antagonists such as Ranitidine or proton pump inhibitors such as Omeprazole), it is advisable to take itraconazole with a cola beverage.

Effects on ability to drive and use machines: Itraconazole may cause dizziness, hearing or vision changes, affecting your ability to drive or operate machinery. Avoid driving, operating machinery, or performing other potentially hazardous tasks until you have determined how you are affected by Sporanox.

Heart failure: Itraconazole may cause symptoms of heart failure to become worse. If you have risk factors for heart failure, discuss with your doctor how Sporanox may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Sporanox, and whether any special monitoring is needed.

Kidney function: Decreased kidney function may affect how well Sporanox works for you. If you have kidney problems, discuss with your doctor how Sporanox may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Sporanox, and whether any special monitoring is needed.

Liver function: Itraconazole may reduce liver function and can cause liver failure. If you have liver problems, discuss with your doctor how Sporanox may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Sporanox, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking Sporanox.

For treatment with itraconazole longer than 30 days, your doctor will order lab tests to monitor liver function. Although serious liver reactions have been rare, contact your doctor if you notice signs of liver problems such as unusual fatigue, loss of appetite, nausea or vomiting, yellowing of the skin or eyes, dark urine, or pale stools.

Pregnancy: Women who may become pregnant must use an effective form of birth control during therapy and for 2 menstrual cycles (2 months) after stopping therapy with itraconazole. Itraconazole should not be used during pregnancy unless the benefit outweighs the risks. It should not be used for the treatment of onychomycoses (fungal nail infections) or dermatomycoses (fungal skin infections) in women who are pregnant or planning to become pregnant. If you become pregnant while taking Sporanox, contact your doctor immediately.

Breast-feeding: Sporanox passes into breast milk. If you are a breast-feeding mother and are taking itraconazole, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The efficacy and safety of using itraconazole have not been established for children.

Seniors: Information regarding the safety and effectiveness of itraconazole when used by seniors is limited. The risk of side effects is greater for people over 65 years of age, so they should Sporanox should only be used if the benefits outweigh the risks.