DIFLUCAN® TABLET, SUSPENSION (Fluconazole TABLET, SUSPENSION) WARNINGS

(Fluconazole TABLET, SUSPENSION)

Prescribing Information

WARNINGS

(1) Hepatic injury: DIFLUCAN should be administered with caution to patients with liver dysfunction. DIFLUCAN has been associated with rare cases of serious hepatic toxicity, including fatalities primarily in patients with serious underlying medical conditions. In cases of DIFLUCAN-associated hepatotoxicity, no obvious relationship to total daily dose, duration of therapy, sex, or age of the patient has been observed. DIFLUCAN hepatotoxicity has usually, but not always, been reversible on discontinuation of therapy. Patients who develop abnormal liver function tests during DIFLUCAN therapy should be monitored for the development of more severe hepatic injury. DIFLUCAN should be discontinued if clinical signs and symptoms consistent with liver disease develop that may be attributable to DIFLUCAN.

(2) Anaphylaxis: In rare cases, anaphylaxis has been reported.

(3) Dermatologic: Exfoliative skin disorders during treatment with DIFLUCAN have been reported. Fatal outcomes have been reported in patients with serious underlying diseases. Patients with deep seated fungal infections who develop rashes during treatment with DIFLUCAN should be monitored closely and the drug discontinued if lesions progress. Fluconazole should be discontinued in patients treated for superficial fungal infection who develop a rash that may be attributed to fluconazole.

(4) Potential for fetal harm: There are no adequate and well-controlled clinical trials of DIFLUCAN in pregnant women. Case reports describe a pattern of distinct congenital anomalies in infants exposed in utero to high dose maternal fluconazole (400 to 800 mg/day) during most or all of the first trimester. These reported anomalies are similar to those seen in animal studies. If DIFLUCAN is used during pregnancy or if the patient becomes pregnant while taking the drug, the patient should be informed of the potential hazard to the fetus. Effective contraceptive measures should be considered in women of child-bearing potential who are being treated with DIFLUCAN 400 to 800 mg/day and should continue throughout the treatment period and for approximately 1 week (5 to 6 half-lives) after the final dose. Epidemiological studies suggest a potential risk of spontaneous abortion and congenital abnormalities in infants whose mothers were treated with 150 mg of fluconazole as a single or repeated dose in the first trimester, but these epidemiological studies have limitations and these findings have not been confirmed in controlled clinical trials. (See PRECAUTIONS: Pregnancy.)

Medication Guide

MEDICATION GUIDE

PATIENT INFORMATION DIFLUCAN® (dye-FLEW-kan) (fluconazole) Tablets
This leaflet contains important information about DIFLUCAN. It is not meant to take the place of your healthcare provider's instructions. Read this information carefully before you take DIFLUCAN. Ask your healthcare provider if you do not understand any of this information or if you want to know more about DIFLUCAN.
What is DIFLUCAN? DIFLUCAN is a prescription medicine used to treat vaginal yeast infections caused by a yeast called Candida. DIFLUCAN helps stop too much yeast from growing in the vagina so the yeast infection goes away. DIFLUCAN is different from other treatments for vaginal yeast infections because it is a tablet taken by mouth. DIFLUCAN is also used for other conditions. However, this leaflet is only about using DIFLUCAN for vaginal yeast infections. For information about using DIFLUCAN for other reasons, ask your healthcare provider. See the section of this leaflet for information about vaginal yeast infections.
What is a vaginal yeast infection? It is normal for a certain amount of yeast to be found in the vagina. Sometimes too much yeast starts to grow in the vagina and this can cause a yeast infection. Vaginal yeast infections are common. About three out of every four adult women will have at least one vaginal yeast infection during their life. Some medicines and medical conditions can increase your chance of getting a yeast infection. If you are pregnant, have diabetes, use birth control pills, or take antibiotics you may get yeast infections more often than other women. Personal hygiene and certain types of clothing may increase your chances of getting a yeast infection. Ask your healthcare provider for tips on what you can do to help prevent vaginal yeast infections. If you get a vaginal yeast infection, you may have any of the following symptoms: • itching • a burning feeling when you urinate • redness • soreness • a thick white vaginal discharge that looks like cottage cheese
Do not take DIFLUCAN if you. • take the following medicines: o quinidine o erythromycin o pimozide o are allergic to fluconazole, the active ingredient in DIFLUCAN, or any of the ingredients in DIFLUCAN. See the end of this Patient Information leaflet for a complete list of ingredients in DIFLUCAN.
Before you take DIFLUCAN, tell your healthcare provider about all of your medical conditions, if you: • have liver problems • have kidney problems • have heart problems including heart arrythmias • have hypokalemia (low potassium) • are pregnant or plan to become pregnant. Tell your healthcare provider right away if you become pregnant while taking DIFLUCAN. You and your healthcare provider will decide if DIFLUCAN is right for you. If you may become pregnant you should use a birth-control (contraceptive) method while taking DIFLUCAN and for 1 week after your final dose. • are breastfeeding or plan to breastfeed. DIFLUCAN can pass into your breastmilk. Talk to your healthcare provider about the best way to feed your baby while you are taking DIFLUCAN. Before you start taking DIFLUCAN, tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take: • diabetes medicines such as glyburide, tolbutamide, glipizide • blood pressure medicines like hydrochlorothiazide, losartan, amlodipine, verapamil, nifedipine or felodipine • blood thinners such as warfarin • cyclosporine, tacrolimus or sirolimus (used to prevent rejection of organ transplants) • rifampin or rifabutin for tuberculosis • phenytoin or carbamazepine to control seizures • theophylline to control asthma • quinidine (used to correct disturbances in heart rhythm) • amiodarone (used for treating uneven heartbeats 'arrhythmias') • amitriptyline or nortriptyline for depression • pimozide for psychiatric illness • amphotericin B or voriconazole for fungal infections • erythromycin for bacterial infections • olaparib, cyclophosphamide or vinca alkaloids such as vincristine or vinblastine for treatment of cancer • fentanyl, alfentanil or methadone for chronic pain • ibrutinib used for treating blood cancer • ivacaftor or ivacaftor combinations, such as tezacaftor/ivacaftor and ivacaftor/tezacaftor/elexacaftor, used to treat cystic fibrosis • lurasidone used to treat schizophrenia or depression • lemborexant, used for the treatment of insomnia • lipid lowering drugs such as atorvastatin, simvastatin, and fluvastatin • non-steroidal anti-inflammatory drugs including celecoxib, ibuprofen, and naproxen • prednisone, a steroid used to treat skin, gastrointestinal, hematological or respiratory disorders • antiviral medications used to treat HIV like saquinavir or zidovudine • tofacitinib for rheumatoid arthritis • abrocitinib (used to treat atopic dermatitis, also known as eczema) • vitamin A nutritional supplement • tolvaptan used to treat hyponatremia (low levels of sodium in your blood) or to slow kidney function decline Since there are many brand names for these medicines, check with your healthcare provider or pharmacist if you have any questions.
How should I take DIFLUCAN? • Take DIFLUCAN exactly as your healthcare provider tells you to. • Take DIFLUCAN by mouth with or without food. • If you take too much DIFLUCAN, call your healthcare provider or go to the nearest emergency room right away.
What should I avoid while taking DIFLUCAN? DIFLUCAN can cause dizziness and seizures. Do not drive or operate machinery until you know how DIFLUCAN affects you.
What are the possible side effects of DIFLUCAN? DIFLUCAN may cause serious side effects including: • serious liver problems. Some people with serious medical problems have developed serious liver problems that became life-threatening or caused death while taking DIFLUCAN. Sometimes these liver problems can be reversed when you stop taking DIFLUCAN. Tell your healthcare provider right away if you have symptoms of serious liver problems including:
	• dark colored urine • severe skin itching • yellowing of the skin and eyes (jaundice)	• light-colored stools • tiredness	• vomiting • loss of appetite
• serious allergic reactions: Serious allergic reactions (anaphylaxis) have happened while taking DIFLUCAN. Stop taking DIFLUCAN, call your healthcare provider or go to the nearest hospital emergency room right away if you get any signs or symptoms of an allergic reaction including:
	• shortness of breath • fever • swelling of the eyelids	• coughing • skin rash, hives, blisters or skin peeling • face, mouth, neck, or any other part of the body	• wheezing • throbbing of the heart or ears • chills
• serious skin problems. Some people with serious medical problems have developed serious skin problems that have caused death while taking DIFLUCAN. Tell your healthcare provider right away if you develop a rash while taking DIFLUCAN. The most common side effects of DIFLUCAN include:
	• headache • dizziness	• diarrhea • stomach pain	• nausea or upset stomach • changes in the way food tastes
Other side effects include: • adrenal insufficiency: Some people who have taken DIFLUCAN developed adrenal insufficiency that was reversible. Tell your healthcare provider right away if you have symptoms of adrenal insufficiency including:
	• long lasting fatigue	• muscle weakness	• loss of appetite
	• weight loss	• stomach pain	• dizziness
	• nausea	• vomiting
• dizziness or seizures.
These are not all the possible side effects of DIFLUCAN. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store DIFLUCAN? Store DIFLUCAN tablets below 86°F (30°C). Keep DIFLUCAN and all medicines out of the reach of children.
General information about the safe and effective use of DIFLUCAN. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use DIFLUCAN for a condition for which it was not prescribed. Do not give DIFLUCAN to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider for information about DIFLUCAN that is written for health professionals.
What are the ingredients in DIFLUCAN? Active ingredient: fluconazole Inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, povidone, croscarmellose sodium, FD&C Red No. 40 aluminum lake dye, and magnesium stearate.
For Medical Information about DIFLUCAN, please visit www.pfizermedinfo.com or call 1-800-438-1985.
This Patient Information has been approved by the U.S. Food and Drug Administration				Revised: 3/2025

LAB-0380-16.0

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