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What is Diflucan?

Diflucan (fluconazole) is an antifungal antibiotic.

Diflucan is used to treat infections caused by fungus, which can invade any part of the body including the mouth, throat, esophagus, lungs, bladder, genital area, and the blood.

Diflucan is also used to prevent fungal infection in people with weak immune systems caused by cancer treatment, bone marrow transplant, or diseases such as AIDS.

Diflucan may also be used for purposes not listed in this medication guide.

Important information about Diflucan

Do not use Diflucan if you are allergic to fluconazole, or similar drugs such as clotrimazole (Lotrimin), econazole (Spectazole), ketoconazole (Nizoral), miconazole (Monistat, Oravig), sertaconazole (Ertaczo), sulconazole (Exelderm), terconazole (Terazol), tioconazole (Vagistat-1), or voriconazole (Vfend). You should not use Diflucan if you are also taking cisapride (Propulsid).

Before taking Diflucan, tell your doctor if you have liver disease, kidney disease, a heart rhythm disorder, or a history of Long QT syndrome.

Take Diflucan for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antifungal medication. Diflucan will not treat a viral infection such as the common cold or flu.

Before taking Diflucan

Do not use Diflucan if you are allergic to fluconazole, or similar drugs such as clotrimazole (Lotrimin), econazole (Spectazole), ketoconazole (Nizoral), miconazole (Monistat, Oravig), sertaconazole (Ertaczo), sulconazole (Exelderm), terconazole (Terazol), tioconazole (Vagistat-1), or voriconazole (Vfend). You should not use Diflucan if you are also taking cisapride (Propulsid).

To make sure you can safely take Diflucan, tell your doctor if you have any of these other conditions:

  • liver disease;

  • kidney disease;

  • a heart rhythm disorder; or

  • a personal or family history of Long QT syndrome.

FDA pregnancy category D. Do not take more than 1 dose of Diflucan if you are pregnant. Long-term use of Diflucan can harm an unborn baby or cause birth defects. Use effective birth control, and tell your doctor if you become pregnant during treatment. A single dose of Diflucan taken to treat a vaginal yeast infection is not expected to harm an unborn baby. Fluconazole can pass into breast milk and may harm a nursing baby. Do not use Diflucan without telling your doctor if you are breast-feeding a baby.

How should I take Diflucan?

Take Diflucan exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your dose will depend on the infection you are treating. Vaginal infections are often treated with only one pill. For other infections, your first dose may be a double dose. Carefully follow your doctor's instructions. Tell your doctor if your symptoms do not improve.

Take Diflucan with a full glass of water. Shake the oral suspension (liquid) well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one. Take Diflucan for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antifungal medication.

Diflucan will not treat a viral infection such as the common cold or flu.

Store Diflucan tablets at room temperature away from moisture and heat. You may store liquid Diflucan in a refrigerator, but do not allow it to freeze. Throw away any leftover liquid medicine that is more than 2 weeks old.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include confusion or unusual thoughts or behavior.

What should I avoid while taking Diflucan?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Diflucan side effects

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

Call your doctor at once if you have any of these serious side effects:

  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  • fever, chills, body aches, flu symptoms;

  • severe blistering, peeling, and red skin rash;

  • easy bruising or bleeding, unusual weakness; or

  • seizure (convulsions).

Less serious Diflucan side effects may include:

  • mild stomach pain, diarrhea, upset stomach;

  • headache;

  • dizziness; or

  • unusual or unpleasant taste in your mouth.

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 other drugs will affect Diflucan?

Tell your doctor about all other medicines you use, especially:

  • a blood thinner such as warfarin (Coumadin, Jantoven);

  • alfentanil (Alfenta), fentanyl (Abstral, Actiq, Fentora, Duragesic, Ionsys, Lazanda, Onsolis);

  • clopidogrel (Plavix);

  • cyclophosphamide (Cytoxan, Neosar);

  • cyclosporine (Gengraf, Sandimmune, Neoral);

  • methadone (Diskets, Dolophine, Methadose);

  • pimozide (Orap);

  • prednisone (Deltasone, Sterapred);

  • saquinavir (Invirase) or zidovudine (Retrovir, Trizivir);

  • sirolimus (Rapamune) or tacrolimus (Prograf);

  • theophylline (Elixophyllin, Theo-24, Theochron, Uniphyl, others);

  • voriconazole (Vfend);

  • an antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol) or nortriptyline (Pamelor);

  • cancer medicine such as vinorelbine (Navelbine), vincristine (Oncovin, Vincasar), or vinblastine (Velban);

  • cholesterol lowering medicines such as atorvastatin (Lipitor, Caduet), fluvastatin (Lescol), lovastatin (Mevacor, Altoprev, Advicor), pravastatin (Pravachol), rosuvastatin (Crestor), or simvastatin (Zocor, Simcor, Vytorin);

  • heart or blood pressure medicine such as amlodipine (Norvasc, Caduet, Exforge, Lotrel, Tekamlo, Tribenzor, Twynsta, Amturnide), felodipine (Plendil), isradipine (Dynacirc), losartan (Cozaar, Hyzaar), or nifedipine (Nifedical, Procardia);

  • NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), and others;

  • oral diabetes medication such as glipizide (Glucotrol), glyburide (Diabeta, Micronase, Glynase), tolbutamide (Orinase), tolazamide (Tolinase), chlorpropamide (Diabinese), and others;

  • rifabutin (Mycobutin) or rifampin (Rifadin, Rifater, Rifamate, Rimactane);

  • a sedative such as diazepam (Valium), lorazepam (Ativan), alprazolam (Xanax), midazolam (Versed), or triazolam (Halcion); or

  • seizure medication such as carbamazepine (Carbatrol, Equetro, Tegretol), phenytoin (Dilantin) or valproic acid (Depakene).

This list is not complete and other drugs may interact with Diflucan. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

For the Consumer

Applies to fluconazole: oral capsule, oral powder for suspension, oral tablet

Along with its needed effects, fluconazole (the active ingredient contained in Diflucan) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking fluconazole:

Rare
  • Abdominal or stomach pain
  • chills
  • clay-colored stools
  • cough
  • dark urine
  • diarrhea
  • difficulty with swallowing
  • dizziness
  • fast heartbeat
  • fever
  • general feeling of tiredness or weakness
  • headache
  • hives
  • itching
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • light-colored stools
  • loss of appetite
  • nausea and vomiting
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • shortness of breath
  • skin rash
  • stomach pain, continuing
  • tightness in the chest
  • unpleasant breath odor
  • unusual tiredness or weakness
  • upper right abdominal or stomach pain
  • vomiting of blood
  • wheezing
  • yellow eyes and skin
Incidence not known
  • Black, tarry stools
  • blistering, peeling, or loosening of the skin
  • chest pain or discomfort
  • convulsions
  • decreased urine
  • dry mouth
  • fainting
  • hoarseness
  • increased thirst
  • irregular or slow heart rate
  • joint or muscle pain
  • loss of bladder control
  • lower back or side pain
  • mood changes
  • muscle pain or cramps
  • muscle spasm or jerking of all extremities
  • numbness or tingling in the hands, feet, or lips
  • painful or difficult urination
  • pale skin
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips
  • sudden loss of consciousness
  • swollen glands
  • unusual bleeding or bruising

Get emergency help immediately if any of the following symptoms of overdose occur while taking fluconazole:

Symptoms of overdose
  • Fearfulness, suspiciousness, or other mental changes
  • seeing, hearing, or feeling things that are not there

Some side effects of fluconazole may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common
  • Acid or sour stomach
  • belching
  • change in taste or bad, unusual, or unpleasant (after) taste
  • heartburn
  • indigestion
  • stomach discomfort or upset
Incidence not known
  • Hair loss or thinning of the hair

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Applies to fluconazole: intravenous solution, oral powder for reconstitution, oral tablet

General

Fluconazole is generally well tolerated. Changes in renal and hematological function test results and hepatic abnormalities have been reported during treatment with fluconazole (the active ingredient contained in Diflucan) and comparative agents in some patients, primarily those with serious underlying diseases such as AIDS and cancer; however, the clinical significance and relationship to therapy is uncertain.

During clinical trials of single dose therapy, side effects possibly related to fluconazole were reported in 26% of patients. In patients receiving active comparative agents, the incidence was 16%. The most common side effects reported in patients receiving a single 150 mg dose of fluconazole for vaginitis were headache, nausea, and abdominal pain. Most side effects were of mild to moderate severity.

During clinical trials of multiple dose therapy, side effects were reported in 16% of patients. Treatment discontinuation occurred in 1.5% and 1.3% of patients due to adverse clinical events and laboratory test abnormalities, respectively. Clinical adverse events were reported more frequently in HIV patients than in non-HIV patients (21% versus 13%); however, the patterns in HIV and non-HIV patients were similar.

Nervous system

Rare cases of seizures have been reported, but a causal relationship was difficult to establish, since some of these patients had cryptococcal meningitis or severe underlying disease. Nonetheless, at least one case of seizure following a 100 mg oral dose has been reported.

Nervous system side effects have included headache (up to 13%) and dysesthesias. Seizures, dizziness, insomnia, paresthesia, somnolence, tremor, and vertigo have been reported during postmarketing experience.

Gastrointestinal

Gastrointestinal side effects have included nausea (up to 7%), abdominal pain (up to 6%), diarrhea (up to 3%), vomiting (1.7%), dyspepsia (1%), taste perversion (1%), anorexia, and general abdominal discomfort. Dry mouth, dyspepsia, vomiting, and taste perversion have been reported during postmarketing experience.

Hepatic

Hepatic side effects have included rare cases of serious hepatic reactions ranging from mild transient transaminase elevations to clinical hepatitis, cholestasis, and fulminant hepatic failure (including fatalities). Transient hepatic reactions (including hepatitis and jaundice), elevated liver function tests (transient and asymptomatic), hepatitis, cholestatic jaundice, and fatal hepatic necrosis have been reported. Serum transaminase elevations (greater than 8 times the upper limit of normal; approximately 1%) and statistically significant increases in AST (SGOT) have been reported. Cholestasis and hepatocellular damage have been reported during postmarketing experience.

Fatal hepatic reactions have occurred primarily in patients with serious underlying medical conditions (primarily AIDS or malignancy) and often taking multiple concomitant medications. One reported patient with AIDS experienced acute hepatic necrosis and hepatic failure approximately 3 weeks after beginning fluconazole therapy.

Transient hepatic reactions have been reported in patients with no other identifiable risk factors. Liver function returned to baseline following fluconazole discontinuation.

Serum transaminase elevations have been reported primarily in patients with serious underlying medical conditions (primarily AIDS or malignancy) and often taking multiple concomitant medications, including agents known to be hepatotoxic.

Dermatologic

Dermatologic side effects have included skin rash (1.8%) and reversible alopecia. Exfoliative skin disorders (including fatalities) have been reported rarely. Acute generalized exanthematous pustulosis, drug eruption, increased sweating, exfoliative skin disorders (including Stevens-Johnson syndrome and toxic epidermal necrolysis), and alopecia have been reported during postmarketing experience.

Reversible alopecia has been associated with long-term (2 months or longer) therapy.

In patients with serious underlying diseases (primarily AIDS and malignancy), exfoliative skin disorders have rarely resulted in a fatal outcome.

Hypersensitivity

A 52-year-old female experienced a fixed drug eruption (FDE) when administered a single oral 400 mg dose of fluconazole (the active ingredient contained in Diflucan) therapy for extensive pityriasis versicolor. Within a 12-hour period, she noticed 3 oval, painful, eroded, pigmented patches over her trunk with diameters of 3 cm to 4 cm and erythematous halos. A clinical diagnosis of FDE caused by fluconazole therapy was made. The FDE was confirmed when the patient was rechallenged with an oral dose of fluconazole 25 mg.

Hypersensitivity side effects have rarely included angioedema and anaphylactic reaction. Rare cases of exfoliative dermatitis and ulcerative eruptions consistent with Stevens-Johnson syndrome have been reported in association with hypersensitivity reactions to fluconazole. Anaphylaxis, generalized edema, stridor, hypotension, and fixed drug eruption have been reported. In rare cases, anaphylaxis (including angioedema, face edema, and pruritus) has been reported during postmarketing experience.

Cardiovascular

Most reports of QT interval prolongation and torsades de pointes involved seriously ill patients with multiple confounding risk factors, such as structural heart disease, electrolyte abnormalities, and concomitant medications that may have been contributory.

An 11-year-old male with neurofibromatosis-1 presented to the hospital in septic shock secondary to a perforated gastric volvulus. After initial stabilization, the patient underwent total gastrectomy and multiple peritoneal lavages. Culture of peritoneal fluid showed infection with Candida albicans. Therapy was initiated with fluconazole (the active ingredient contained in Diflucan) 150 mg intravenously every 12 hours. After initiating fluconazole therapy, the patient developed QT prolongation and complex ventricular arrhythmia. Fluconazole was discontinued. Over the subsequent 36-hours, the patient remained in sinus rhythm except for one brief run of ventricular bigeminy. An ECG recorded 5 months after admission (and approximately 4 months after cessation of all QT-prolonging medications) showed sinus rhythm with normal heart rate and corrected QT interval.

Cardiovascular side effects have included prolongation of the QT interval on the electrocardiogram (ECG) and palpitations. QT prolongation and torsades de pointes have been reported during postmarketing experience.

Hematologic

Anemia, eosinophilia, leukopenia, neutropenia, and thrombocytopenia have been reported, often in patients with severe deep fungal infections or underlying disease.

Spontaneous reports of anemia were more frequent in patients 65 years of age or older than in those between 12 and 65 years of age; however, there is a natural increase in the incidence of anemia in the elderly. A causal relationship to drug exposure could not be determined.

Hematologic side effects have included anemia, leukopenia, neutropenia, agranulocytosis, and thrombocytopenia during postmarketing experience. Eosinophilia has been reported.

Renal

A 58-year-old female with a history of hypertension and cervical cancer experienced membranous nephropathy coincident with fluconazole (the active ingredient contained in Diflucan) therapy. The patient presented with increasing generalized edema accompanied by nausea and indigestion for 3 weeks. Clinical findings showed the patient had stage I membranous nephropathy. At initial presentation, the patient's medication history included amlodipine, hydrochlorothiazide, metoclopramide, and levosulpiride. She did not admit to taking fluconazole therapy. Five months after the initial presentation, the patient returned with reports of increasing pedal edema. At that point, the patient admitted to taking fluconazole once weekly for tinea pedis. Off fluconazole, the patient went into complete remission.

Spontaneous reports of acute renal failure were more frequent in patients 65 years of age or older than in those between 12 and 65 years of age; however, there is a natural increase in the incidence of renal failure in the elderly. A causal relationship to drug exposure could not be determined.

Renal side effects have included at least one case of membranous nephropathy. Acute renal failure has been reported during postmarketing experience.

Metabolic

Metabolic side effects have included hypercholesterolemia, hypertriglyceridemia, and hypokalemia during postmarketing experience.

Other

Other side effects have included fever, asthenia, fatigue, and malaise during postmarketing experience.

Respiratory

Respiratory side effects have included respiratory disorders.

Musculoskeletal

Musculoskeletal side effects have included back and joint pain. Finger stiffness has been reported, although the association to therapy was questionable. Myalgia has been reported during postmarketing experience.