Side Effects Of Diflucan

Contents

Very common (10% or more): Increased ALT, increased AST

Diflucan Side Effects Center

Diflucan (fluconazole) is an antifungal medication prescribed to treat Candida fungal infections of the mouth, vagina, esophagus, lungs, urinary tract, abdomen, and other organs. Diflucan is also used to treat fungal meningitis and may be prescribed to ward off fungal infections in patients being treated with chemotherapy or radiation before a bone marrow transplant. Diflucan is available as a generic drug.

What Are Side Effects of Diflucan?

Diflucan may cause serious side effects including:

fast or pounding heartbeat
flutter in your chest
shortness of breath
sudden dizziness
fever
chills
body aches
flu symptoms
easy bruising or bleeding
unusual weakness
seizure (convulsions)
skin rash or lesions
loss of appetite
upper stomach pain
dark urine
clay-colored stool
yellowing of eyes or skin (jaundice)

Get medical help right away, if you have any of the symptoms listed above.

Common side effects of Diflucan include:

headache,
dizziness,
drowsiness,
stomach or abdominal pain,
upset stomach,
diarrhea,
heartburn,
loss of appetite, and
allergic reactions including skin inflammation, itching, rash, and unusual or unpleasant taste in your mouth.

Seek medical care or call 911 at once if you have the following serious side effects:

Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Diflucan

Diflucan is available in several strengths and comes as a tablet (50, 100, 150 and 200 mg strength), liquid (350 or 1400 mg strength), or injection (2 mg per ml). Diflucan is taken once a day and may be taken for several weeks depending on the condition being treated.

What Drugs, Substances, or Supplements Interact with Diflucan?

Drug interactions may occur with certain antibiotics, blood thinners, diuretics, sedatives, antiseizure drugs, and other medications. Warnings may apply to individuals who have liver disease. In rare cases, patients treated with Diflucan may develop dangerous heart rhythm abnormalities or serious allergic reactions.

Diflucan During Pregnancy and Breastfeeding

Diflucan is not usually recommended for pregnant women or nursing mothers. Diflucan has been used in the pediatric population, but its dose is determined by pediatric patient weight ranges and a mg/Kg sliding scale.

Additional Information

Our Diflucan 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

Diflucan Consumer Information

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Call your doctor at once if you have:

fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);
seizure (convulsions);
skin rash or skin lesions; or
liver problems–loss of appetite, stomach pain (upper right side), dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

nausea, stomach pain, diarrhea, upset stomach;
headache;
dizziness; or
changes in your sense of taste.

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.

QUESTION

Diflucan Professional Information

SIDE EFFECTS

DIFLUCAN is generally well tolerated.

In some patients, particularly those with serious underlying diseases such as AIDS and cancer, changes in renal and hematological function test results and hepatic abnormalities have been observed during treatment with fluconazole and comparative agents, but the clinical significance and relationship to treatment is uncertain.

In Patients Receiving A Single Dose For Vaginal Candidiasis

During comparative clinical studies conducted in the United States, 448 patients with vaginal candidiasis were treated with DIFLUCAN, 150 mg single dose. The overall incidence of side effects possibly related to DIFLUCAN was 26%. In 422 patients receiving active comparative agents, the incidence was 16%. The most common treatment-related adverse events reported in the patients who received 150 mg single dose fluconazole for vaginitis were headache (13%), nausea (7%), and abdominal pain (6%). Other side effects reported with an incidence equal to or greater than 1% included diarrhea (3%), dyspepsia (1%), dizziness (1%), and taste perversion (1%). Most of the reported side effects were mild to moderate in severity. Rarely, angioedema and anaphylactic reaction have been reported in marketing experience.

In Patients Receiving Multiple Doses For Other Infections

Sixteen percent of over 4000 patients treated with DIFLUCAN (fluconazole) in clinical trials of 7 days or more experienced adverse events. Treatment was discontinued in 1.5% of patients due to adverse clinical events and in 1.3% of patients due to laboratory test abnormalities.

Clinical adverse events were reported more frequently in HIV infected patients (21%) than in non-HIV infected patients (13%); however, the patterns in HIV infected and non-HIV infected patients were similar. The proportions of patients discontinuing therapy due to clinical adverse events were similar in the two groups (1.5%).

The following treatment-related clinical adverse events occurred at an incidence of 1% or greater in 4048 patients receiving DIFLUCAN for 7 or more days in clinical trials: nausea 3.7%, headache 1.9%, skin rash 1.8%, vomiting 1.7%, abdominal pain 1.7%, and diarrhea 1.5%.

Hepato-Biliary

In combined clinical trials and marketing experience, there have been rare cases of serious hepatic reactions during treatment with DIFLUCAN. (See WARNINGS.) The spectrum of these hepatic reactions has ranged from mild transient elevations in transaminases to clinical hepatitis, cholestasis and fulminant hepatic failure, including fatalities. Instances of fatal hepatic reactions were noted to occur primarily in patients with serious underlying medical conditions (predominantly AIDS or malignancy) and often while taking multiple concomitant medications. Transient hepatic reactions, including hepatitis and jaundice, have occurred among patients with no other identifiable risk factors. In each of these cases, liver function returned to baseline on discontinuation of DIFLUCAN.

In two comparative trials evaluating the efficacy of DIFLUCAN for the suppression of relapse of cryptococcal meningitis, a statistically significant increase was observed in median AST (SGOT) levels from a baseline value of 30 IU/L to 41 IU/L in one trial and 34 IU/L to 66 IU/L in the other. The overall rate of serum transaminase elevations of more than 8 times the upper limit of normal was approximately 1% in fluconazole-treated patients in clinical trials. These elevations occurred in patients with severe underlying disease, predominantly AIDS or malignancies, most of whom were receiving multiple concomitant medications, including many known to be hepatotoxic. The incidence of abnormally elevated serum transaminases was greater in patients taking DIFLUCAN concomitantly with one or more of the following medications: rifampin, phenytoin, isoniazid, valproic acid, or oral sulfonylurea hypoglycemic agents.

Post-Marketing Experience

In addition, the following adverse events have occurred during post-marketing experience.

Immunologic: In rare cases, anaphylaxis (including angioedema, face edema and pruritus) has been reported.

Body as a Whole: Asthenia, fatigue, fever, malaise.

Cardiovascular: QT prolongation, torsade de pointes. (See PRECAUTIONS.)

Central Nervous System: Seizures, dizziness.

Hematopoietic and Lymphatic: Leukopenia, including neutropenia and agranulocytosis, thrombocytopenia.

Metabolic: Hypercholesterolemia, hypertriglyceridemia, hypokalemia.

Gastrointestinal: Cholestasis, dry mouth, hepatocellular damage, dyspepsia, vomiting.

Other Senses: Taste perversion.

Musculoskeletal System: myalgia.

Nervous System: Insomnia, paresthesia, somnolence, tremor, vertigo.

Skin and Appendages: Acute generalized exanthematous pustulosis, drug eruption including fixed drug eruption, increased sweating, exfoliative skin disorders including Stevens-Johnson syndrome and toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) (See WARNINGS), alopecia.

Adverse Reactions In Children

The pattern and incidence of adverse events and laboratory abnormalities recorded during pediatric clinical trials are comparable to those seen in adults.

In Phase II/III clinical trials conducted in the United States and in Europe, 577 pediatric patients, ages 1 day to 17 years were treated with DIFLUCAN at doses up to 15 mg/kg/day for up to 1,616 days. Thirteen percent of children experienced treatment-related adverse events. The most commonly reported events were vomiting (5%), abdominal pain (3%), nausea (2%), and diarrhea (2%). Treatment was discontinued in 2.3% of patients due to adverse clinical events and in 1.4% of patients due to laboratory test abnormalities. The majority of treatment-related laboratory abnormalities were elevations of transaminases or alkaline phosphatase.

Percentage Of Patients With Treatment-Related Side Effects

Fluconazole (N=577)	Comparative Agents (N=451)
With any side effect	13.0	9.3
Vomiting	5.4	5.1
Abdominal pain	2.8	1.6
Nausea	2.3	1.6
Diarrhea	2.1	2.2

DRUG INTERACTIONS

(See CONTRAINDICATIONS.) Fluconazole is a moderate CYP2C9 and CYP3A4 inhibitor. Fluconazole is also a strong inhibitor of CYP2C19. Patients treated with DIFLUCAN, who are also concomitantly treated with drugs with a narrow therapeutic window metabolized through CYP2C9 and CYP3A4, should be monitored for adverse reactions associated with the concomitantly administered drugs. In addition to the observed /documented interactions mentioned below, there is a risk of increased plasma concentration of other compounds metabolized by CYP2C9, CYP2C19, and CYP3A4 coadministered with fluconazole. Therefore, caution should be exercised when using these combinations and the patients should be carefully monitored. The enzyme inhibiting effect of fluconazole persists 4 to 5 days after discontinuation of fluconazole treatment due to the long half-life of fluconazole. Clinically or potentially significant drug interactions between DIFLUCAN and the following agents/classes have been observed and are described in greater detail below:

Alfentanil

A study observed a reduction in clearance and distribution volume as well as prolongation of t½ of alfentanil following concomitant treatment with fluconazole. A possible mechanism of action is fluconazole’s inhibition of CYP3A4. Dosage adjustment of alfentanil may be necessary.

Amiodarone

Concomitant administration of fluconazole with amiodarone may increase QT prolongation. Caution must be exercised if the concomitant use of fluconazole and amiodarone is necessary, notably with high-dose fluconazole (800 mg).

Amitriptyline, Nortriptyline

Fluconazole increases the effect of amitriptyline and nortriptyline. 5-Nortriptyline and/or S-amitriptyline may be measured at initiation of the combination therapy and after 1 week. Dosage of amitriptyline/nortriptyline should be adjusted, if necessary.

Amphotericin B

Concurrent administration of fluconazole and amphotericin B in infected normal and immunosuppressed mice showed the following results: a small additive antifungal effect in systemic infection with Candida albicans, no interaction in intracranial infection with Cryptococcus neoformans, and antagonism of the two drugs in systemic infection with A. fumigatus. The clinical significance of results obtained in these studies is unknown.

Azithromycin

An open-label, randomized, three-way crossover study in 18 healthy subjects assessed the effect of a single 1200 mg oral dose of azithromycin on the pharmacokinetics of a single 800 mg oral dose of fluconazole as well as the effects of fluconazole on the pharmacokinetics of azithromycin. There was no significant pharmacokinetic interaction between fluconazole and azithromycin.

Calcium Channel Blockers

Certain calcium channel antagonists (nifedipine, isradipine, amlodipine, verapamil, and felodipine) are metabolized by CYP3A4. Fluconazole has the potential to increase the systemic exposure of the calcium channel antagonists. Frequent monitoring for adverse events is recommended.

Carbamazepine

Fluconazole inhibits the metabolism of carbamazepine and an increase in serum carbamazepine of 30% has been observed. There is a risk of developing carbamazepine toxicity. Dosage adjustment of carbamazepine may be necessary depending on concentration measurements/effect.

Celecoxib

During concomitant treatment with fluconazole (200 mg daily) and celecoxib (200 mg), the celecoxib Cmax and AUC increased by 68% and 134%, respectively. Half of the celecoxib dose may be necessary when combined with fluconazole.

Coumarin-Type Anticoagulants

Prothrombin time may be increased in patients receiving concomitant DIFLUCAN and coumarin-type anticoagulants. In post-marketing experience, as with other azole antifungals, bleeding events (bruising, epistaxis, gastrointestinal bleeding, hematuria, and melena) have been reported in association with increases in prothrombin time in patients receiving fluconazole concurrently with warfarin. Careful monitoring of prothrombin time in patients receiving DIFLUCAN and coumarin-type anticoagulants is recommended. Dose adjustment of warfarin may be necessary. (See CLINICAL PHARMACOLOGY: Drug Interaction Studies.)

Cyclophosphamide

Combination therapy with cyclophosphamide and fluconazole results in an increase in serum bilirubin and serum creatinine. The combination may be used while taking increased consideration to the risk of increased serum bilirubin and serum creatinine.

Cyclosporine

DIFLUCAN significantly increases cyclosporine levels in renal transplant patients with or without renal impairment. Careful monitoring of cyclosporine concentrations and serum creatinine is recommended in patients receiving DIFLUCAN and cyclosporine. (See CLINICAL PHARMACOLOGY: Drug Interaction Studies.) This combination may be used by reducing the dosage of cyclosporine depending on cyclosporine concentration.

Fentanyl

One fatal case of possible fentanyl-fluconazole interaction was reported. The author judged that the patient died from fentanyl intoxication. Furthermore, in a randomized crossover study with 12 healthy volunteers, it was shown that fluconazole delayed the elimination of fentanyl significantly. Elevated fentanyl concentration may lead to respiratory depression.

HMG-CoA Reductase Inhibitors

The risk of myopathy and rhabdomyolysis increases when fluconazole is coadministered with HMG-CoA reductase inhibitors metabolized through CYP3A4, such as atorvastatin and simvastatin, or through CYP2C9, such as fluvastatin. If concomitant therapy is necessary, the patient should be observed for symptoms of myopathy and rhabdomyolysis and creatinine kinase should be monitored. HMG-CoA reductase inhibitors should be discontinued if a marked increase in creatinine kinase is observed or myopathy/rhabdomyolysis is diagnosed or suspected.

Hydrochlorothiazide

In a pharmacokinetic interaction study, coadministration of multiple-dose hydrochlorothiazide to healthy volunteers receiving fluconazole increased plasma concentrations of fluconazole by 40%. An effect of this magnitude should not necessitate a change in the fluconazole dose regimen in subjects receiving concomitant diuretics.

Ibrutinib

Moderate inhibitors of CYP3A4 such as fluconazole may increase plasma ibrutinib concentrations and increase risk of adverse reactions associated with ibrutinib. If ibrutinib and fluconazole are concomitantly administered, reduce the dose of ibrutinib as instructed in ibrutinib prescribing information and the patient should be frequently monitored for any adverse reactions associated with ibrutinib.

Lemborexant

Concomitant administration of fluconazole increased lemborexant Cmax and AUC by approximately 1.6- and 4.2-fold, respectively which is expected to increase risk of adverse reactions, such as somnolence. Avoid concomitant use of DIFLUCAN with lemborexant.

Losartan

Fluconazole inhibits the metabolism of losartan to its active metabolite (E-31 74) which is responsible for most of the angiotensin Il-receptor antagonism which occurs during treatment with losartan. Patients should have their blood pressure monitored continuously.

Methadone

Fluconazole may enhance the serum concentration of methadone. Dosage adjustment of methadone may be necessary.

Non-Steroidal Anti-Inflammatory Drugs

The Cmax and AUC of flurbiprofen were increased by 23% and 81%, respectively, when coadministered with fluconazole compared to administration of flurbiprofen alone. Similarly, the Cmax and AUC of the pharmacologically active isomer [S-(+)-ibuprofen] were increased by 15% and 82%, respectively, when fluconazole was coadministered with racemic ibuprofen (400 mg) compared to administration of racemic ibuprofen alone.

Although not specifically studied, fluconazole has the potential to increase the systemic exposure of other non-steroidal anti-inflammatory drugs (NSAIDs) that are metabolized by CYP2C9 (e.g., naproxen, lornoxicam, meloxicam, diclofenac). Frequent monitoring for adverse events and toxicity related to NSAIDs is recommended. Adjustment of dosage of NSAIDs may be needed.

Olaparib

Moderate inhibitors of CYP3A4 such as fluconazole increase olaparib plasma concentrations; concomitant use is not recommended. If the combination cannot be avoided, reduce the dose of olaparib as instructed in the LYNPARZA® (Olaparib) Prescribing Information.

Oral Contraceptives

Two pharmacokinetic studies with a combined oral contraceptive have been performed using multiple doses of fluconazole. There were no relevant effects on hormone level in the 50 mg fluconazole study, while at 200 mg daily, the AUCs of ethinyl estradiol and levonorgestrel were increased 40% and 24%, respectively. Thus, multiple-dose use of fluconazole at these doses is unlikely to have an effect on the efficacy of the combined oral contraceptive.

Oral Hypoglycemics

Clinically significant hypoglycemia may be precipitated by the use of DIFLUCAN with oral hypoglycemic agents; one fatality has been reported from hypoglycemia in association with combined DIFLUCAN and glyburide use. DIFLUCAN reduces the metabolism of tolbutamide, glyburide, and glipizide and increases the plasma concentration of these agents. When DIFLUCAN is used concomitantly with these or other sulfonylurea oral hypoglycemic agents, blood glucose concentrations should be carefully monitored and the dose of the sulfonylurea should be adjusted as necessary. (See CLINICAL PHARMACOLOGY: Drug Interaction Studies.)

Phenytoin

DIFLUCAN increases the plasma concentrations of phenytoin. Careful monitoring of phenytoin concentrations in patients receiving DIFLUCAN and phenytoin is recommended. (See CLINICAL PHARMACOLOGY: Drug Interaction Studies.)

Pimozide

Although not studied in vitro or in vivo, concomitant administration of fluconazole with pimozide may result in inhibition of pimozide metabolism. Increased pimozide plasma concentrations can lead to QT prolongation and rare occurrences of torsade de pointes. Coadministration of fluconazole and pimozide is contraindicated.

Prednisone

There was a case report that a liver-transplanted patient treated with prednisone developed acute adrenal cortex insufficiency when a 3 month therapy with fluconazole was discontinued. The discontinuation of fluconazole presumably caused an enhanced CYP3A4 activity which led to increased metabolism of prednisone. Patients on long-term treatment with fluconazole and prednisone should be carefully monitored for adrenal cortex insufficiency when fluconazole is discontinued.

Quinidine

Although not studied in vitro or in vivo, concomitant administration of fluconazole with quinidine may result in inhibition of quinidine metabolism. Use of quinidine has been associated with QT prolongation and rare occurrences of torsade de pointes. Coadministration of fluconazole and quinidine is contraindicated. (See CONTRAINDICATIONS.)

Rifabutin

There have been reports that an interaction exists when fluconazole is administered concomitantly with rifabutin, leading to increased serum levels of rifabutin up to 80%. There have been reports of uveitis in patients to whom fluconazole and rifabutin were coadministered. Patients receiving rifabutin and fluconazole concomitantly should be carefully monitored. (See CLINICAL PHARMACOLOGY: Drug Interaction Studies.)

Rifampin

Rifampin enhances the metabolism of concurrently administered DIFLUCAN. Depending on clinical circumstances, consideration should be given to increasing the dose of DIFLUCAN when it is administered with rifampin. (See CLINICAL PHARMACOLOGY: Drug Interaction Studies.)

Saquinavir

Fluconazole increases the AUC of saquinavir by approximately 50%, Cmax by approximately 55%, and decreases the clearance of saquinavir by approximately 50% due to inhibition of saquinavir’s hepatic metabolism by CYP3A4 and inhibition of P-glycoprotein. Dosage adjustment of saquinavir may be necessary.

Short-Acting Benzodiazepines

Following oral administration of midazolam, fluconazole resulted in substantial increases in midazolam concentrations and psychomotor effects. This effect on midazolam appears to be more pronounced following oral administration of fluconazole than with fluconazole administered intravenously. If short-acting benzodiazepines, which are metabolized by the cytochrome P450 system, are concomitantly administered with fluconazole, consideration should be given to decreasing the benzodiazepine dosage, and the patients should be appropriately monitored. (See CLINICAL PHARMACOLOGY: Drug Interaction Studies.)

Sirolimus

Fluconazole increases plasma concentrations of sirolimus presumably by inhibiting the metabolism of sirolimus via CYP3A4 and P-glycoprotein. This combination may be used with a dosage adjustment of sirolimus depending on the effect/concentration measurements.

Tacrolimus

Fluconazole may increase the serum concentrations of orally administered tacrolimus up to 5 times due to inhibition of tacrolimus metabolism through CYP3A4 in the intestines. No significant pharmacokinetic changes have been observed when tacrolimus is given intravenously. Increased tacrolimus levels have been associated with nephrotoxicity. Dosage of orally administered tacrolimus should be decreased depending on tacrolimus concentration. (See CLINICAL PHARMACOLOGY: Drug Interaction Studies.)

Theophylline

DIFLUCAN increases the serum concentrations of theophylline. Careful monitoring of serum theophylline concentrations in patients receiving DIFLUCAN and theophylline is recommended. (See CLINICAL PHARMACOLOGY: Drug Interaction Studies.)

Tofacitinib

Systemic exposure to tofacitinib is increased when tofacitinib is coadministered with fluconazole. Reduce the dose of tofacitinib when given concomitantly with fluconazole (i.e., from 5 mg twice daily to 5 mg once daily as instructed in the XELJANZ [tofacitinib] label). (See CLINICAL PHARMACOLOGY: Drug Interaction Studies.)

Tolvaptan

Plasma exposure to tolvaptan is significantly increased (200% in AUC; 80% in Cmax) when tolvaptan, a CYP3A4 substrate, is coadministered with fluconazole, a moderate CYP3A4 inhibitor. This interaction may result in the risk of a significant increase in adverse reactions associated with tolvaptan, particularly significant diuresis, dehydration, and acute renal failure. If tolvaptan and fluconazole are concomitantly administered, the tolvaptan dose should be reduced as instructed in the tolvaptan prescribing information and the patient should be frequently monitored for any adverse reactions associated with tolvaptan.

Triazolam

Fluconazole increases the AUC of triazolam (single dose) by approximately 50%, Cmax by 20% to 32%, and increases t½ by 25% to 50 % due to the inhibition of metabolism of triazolam. Dosage adjustments of triazolam may be necessary.

Vinca Alkaloids

Although not studied, fluconazole may increase the plasma levels of the vinca alkaloids (e.g., vincristine and vinblastine) and lead to neurotoxicity, which is possibly due to an inhibitory effect on CYP3A4.

Vitamin A

Based on a case report in one patient receiving combination therapy with all-trans-retinoid acid (an acid form of vitamin A) and fluconazole, central nervous system (CNS) related undesirable effects have developed in the form of pseudotumor cerebri, which disappeared after discontinuation of fluconazole treatment. This combination may be used but the incidence of CNS related undesirable effects should be borne in mind.

Voriconazole

Avoid concomitant administration of voriconazole and fluconazole. Monitoring for adverse events and toxicity related to voriconazole is recommended; especially, if voriconazole is started within 24 h after the last dose of fluconazole. (See CLINICAL PHARMACOLOGY: Drug Interaction Studies.)

Zidovudine

Fluconazole increases the Cmax and AUC of zidovudine by 84% and 74%, respectively, due to an approximately 45% decrease in oral zidovudine clearance. The half-life of zidovudine was likewise prolonged by approximately 128% following combination therapy with fluconazole. Patients receiving this combination should be monitored for the development of zidovudine-related adverse reactions. Dosage reduction of zidovudine may be considered.

Physicians should be aware that interaction studies with medications other than those listed in the CLINICAL PHARMACOLOGY section have not been conducted, but such interactions may occur.

Read the entire FDA prescribing information for Diflucan (Fluconazole)

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Fluconazole Injection Drug Imprint

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Diflucan 100 mg

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Diflucan 150 mg

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Diflucan 200 mg

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Diflucan 50 mg

trapezoid, pink, imprinted with DIFLUCAN 50, ROERIG

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Fluconazole 100 mg-GRE

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Fluconazole 150 mg-GRE

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Fluconazole 150 mg-PAR

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Fluconazole 150 mg-TEV

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Fluconazole 200 mg-GRE

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Fluconazole 200 mg-TAR

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Fluconazole 200 mg-TEV

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Fluconazole 50 mg 551110143

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Fluconazole 50 mg 674050601

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Fluconazole 50 mg-GRE

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Fluconazole 50 mg-TEV

round, peach, imprinted with 50, N 550

Fluconazole Side Effects

Medically reviewed by Drugs.com. Last updated on Nov 8, 2022.

Summary

More frequently reported side effects include: vomiting. Continue reading for a comprehensive list of adverse effects.

Applies to fluconazole: oral powder for suspension, oral tablet. Other dosage forms:

Serious side effects of Fluconazole

Along with its needed effects, fluconazole 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

Chest tightness
chills
clay-colored stools
cough
dark urine
diarrhea
difficulty with swallowing
dizziness
fast heartbeat
fever
headache
hives, itching, or skin rash
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
light-colored stools
loss of appetite
nausea
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
stomach pain, continuing
unpleasant breath odor
unusual tiredness or weakness
upper right abdominal or stomach pain
vomiting
vomiting of blood
yellow eyes and skin

Incidence not known

Black, tarry stools
blistering, peeling, or loosening of the skin
chest pain or discomfort
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 the arms and legs
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
seizures
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

Other side effects of Fluconazole

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

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

For Healthcare Professionals

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

General

This drug was generally well tolerated. Changes in renal and hematological function test results and hepatic abnormalities reported during therapy with this and comparative agents in some patients, primarily those with serious underlying diseases (e.g., AIDS, cancer); clinical significance and relationship to therapy unclear.

During clinical trials of single-dose therapy, side effects possibly related to therapy were reported in 26% of patients using this drug and 16% of patients using active comparative agents. The most common side effects reported in patients receiving a single 150 mg dose of this drug 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. Therapy discontinuation occurred in 1.5% and 1.3% of patients due to adverse clinical events and laboratory test abnormalities, respectively. Clinical side effects were reported more often in HIV-infected patients than in non-HIV-infected patients (21% versus 13%), but the patterns in both groups were similar. [Ref]

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 1 case of seizure following a 100 mg oral dose has been reported.

Seizures, dizziness, paresthesia, somnolence, tremor, and vertigo have also been reported during postmarketing experience. [Ref]

Very common (10% or more): Headache (up to 13%)

Uncommon (0.1% to 1%): Seizures, dizziness, paresthesia, somnolence, vertigo, visual field defect, taste perversion, hyperkinesia, hypertonia

Rare (less than 0.1%): Tremor

Frequency not reported: Dysesthesias [Ref]

Gastrointestinal

Dry mouth, dyspepsia, and vomiting have also been reported during postmarketing experience. [Ref]

Very common (10% or more): Nausea, abdominal pain, diarrhea, vomiting

Common (1% to 10%): Dyspepsia

Uncommon (0.1% to 1%): Constipation, flatulence, loose stools, dry mouth

Frequency not reported: General abdominal discomfort [Ref]

Hepatic

Very common (10% or more): Increased ALT, increased AST

Uncommon (0.1% to 1%): Serum transaminase elevations, cholestasis, jaundice, increased bilirubin

Rare (less than 0.1%): Serious hepatic reactions, hepatic toxicity (including fatalities), hepatic failure, hepatocellular necrosis, hepatitis, hepatocellular damage

Frequency not reported: Hepatic reactions (ranging from mild transient transaminase elevations to clinical hepatitis, fulminant hepatic failure [including fatalities]), transient hepatic reactions (including hepatitis, jaundice), elevated liver function tests (transient and asymptomatic), cholestatic jaundice, fatal hepatic necrosis, increased plasma levels of hepatic enzymes [Ref]

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 about 3 weeks after starting this drug.

Transient hepatic reactions have been reported in patients with no other identifiable risk factors. Liver function returned to baseline after stopping this drug.

Serum transaminase elevations (greater than 8 times the upper limit of normal [8 x ULN]; about 1%) and statistically significant increases in AST have been reported. 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.

Transaminase elevations greater than 2 to 3 x ULN have also been reported.

Cholestasis, hepatocellular damage, and hepatocellular necrosis have also been reported during postmarketing experience. [Ref]

Dermatologic

Very common (10% or more): Rash

Common (1% to 10%): Maculopapular erythema

Uncommon (0.1% to 1%): Pruritus, genital pruritus, erythematous rash, dry skin, abnormal skin odor, urticaria, herpes simplex, drug eruption, increased sweating

Rare (less than 0.1%): Angioedema, exfoliative skin disorders (including Stevens-Johnson syndrome, toxic epidermal necrolysis), alopecia, acute generalized exanthematous pustulosis, exfoliative dermatitis

Frequency not reported: Reversible alopecia, exfoliative skin disorders (including fatalities) [Ref]

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 resulted in a fatal outcome.

Acute generalized exanthematous pustulosis, drug eruption, increased sweating, exfoliative skin disorders (including Stevens-Johnson syndrome, toxic epidermal necrolysis), and alopecia have also been reported during postmarketing experience. [Ref]

Metabolic

Hypercholesterolemia, hypertriglyceridemia, and hypokalemia have also been reported during postmarketing experience. [Ref]

Very common (10% or more): Increased blood alkaline phosphatase

Uncommon (0.1% to 1%): Hypokalemia, anorexia, decreased appetite

Rare (less than 0.1%): Hypercholesterolemia, hypertriglyceridemia [Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity reactions (including generalized edema, stridor, hypotension, exfoliative dermatitis, ulcerative eruptions), fixed drug eruption

Postmarketing reports: Anaphylaxis (including angioedema, face edema, pruritus) [Ref]

Rare cases of exfoliative dermatitis and ulcerative eruptions consistent with Stevens-Johnson syndrome have been reported in association with hypersensitivity reactions.

A 52-year-old female experienced a fixed drug eruption (FDE) when administered a single 400 mg oral dose for extensive pityriasis versicolor. Within 12 hours, she noticed 3 oval, painful, eroded, pigmented patches over her trunk with diameters of 3 to 4 cm and erythematous halos. A clinical diagnosis of FDE due to drug therapy was made. The FDE was confirmed when the patient was rechallenged with a 25 mg oral dose. [Ref]

Cardiovascular

Rare (less than 0.1%): QT prolongation, torsade de pointes

Frequency not reported: Prolongation of the QT interval on the ECG, palpitations, complex ventricular arrhythmia [Ref]

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 started with fluconazole 150 mg IV every 12 hours. After starting this drug, the patient developed QT prolongation and complex ventricular arrhythmia. The drug 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 about 4 months after cessation of all QT-prolonging medications) showed sinus rhythm with normal heart rate and corrected QT interval.

QT prolongation and torsade de pointes have also been reported during postmarketing experience. [Ref]

Hematologic

Uncommon (0.1% to 1%): Anemia

Frequency not reported: Eosinophilia [Ref]

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.

Anemia, leukopenia, neutropenia, agranulocytosis, and thrombocytopenia have also been reported during postmarketing experience. [Ref]

Other

Fever, asthenia, fatigue, and malaise have also been reported during postmarketing experience. [Ref]

Uncommon (0.1% to 1%): Thirst, fatigue, malaise, pain, rigors, asthenia, fever, flushing, hot flushes

Rare (less than 0.1%): Face edema

Frequency not reported: Infection due to resistant microorganisms [Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Back pain, myalgia

Frequency not reported: Joint pain, finger stiffness [Ref]

Myalgia has also been reported during postmarketing experience. [Ref]

Psychiatric

Insomnia has also been reported during postmarketing experience.

Uncommon (0.1% to 1%): Insomnia, nervousness

Renal

Uncommon (0.1% to 1%): Polyuria, renal pain, changes in renal function tests

Frequency not reported: Membranous nephropathy

Postmarketing reports: Acute renal failure [Ref]

A 58-year-old female with a history of hypertension and cervical cancer experienced membranous nephropathy coincident with this drug. 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. Five months after the initial presentation, the patient returned with reports of increasing pedal edema. At that point, the patient admitted to taking this drug once a week for tinea pedis. The patient went into complete remission when the drug was stopped.

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. [Ref]

Genitourinary

Uncommon (0.1% to 1%): Intermenstrual bleeding, dysmenorrhea, leukorrhea, menorrhagia, uterine spasm, vaginal disorders, female sexual dysfunction

Respiratory

Frequency not reported: Respiratory disorders [Ref]

Ocular

Uncommon (0.1% to 1%): Abnormal vision

Frequently asked questions

Fluconazole – How long does it take to work?
Does fluconazole flush out yeast/discharge?
Fluconazole – can you drink alcohol while using one dose of 150mg one time?
What is the dose of fluconazole for tinea? Is it is indicated for tinea infections?
I am having a reaction after taking fluconazole and would like to know if this is normal?

More about fluconazole

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During pregnancy
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Drug class: azole antifungals
Breastfeeding
En español

Patient resources

Drug Information
Fluconazole (Advanced Reading)
Fluconazole Intravenous (Advanced Reading)
Fluconazole Tablets
Fluconazole Injection Solution
Fluconazole Oral Suspension

Other brands

Professional resources

Related treatment guides

Candida Urinary Tract Infection
Candidemia
Blastomycosis
Bone Marrow Transplantation

References

1. Grant SM, Clissold SP “Fluconazole: a review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential in superficial and systemic mycoses.” Drugs 39 (1990): 877-916

2. “Product Information. Diflucan (fluconazole).” Roerig Division (2001):

3. Cerner Multum, Inc. “UK Summary of Product Characteristics.” O 0

4. Cerner Multum, Inc. “Australian Product Information.” O 0

5. Phillips RJ, Watson SA, McKay FF “An open multicentre study of the efficacy and safety of a single dose of fluconazole 150 mg in the treatment of vaginal candidiasis in general practice.” Br J Clin Pract 44 (1990): 219-22

6. Saag MS, Powderly WG, Cloud GA, et al. “Comparison of amphotericin B with fluconazole in the treatment of acute AIDS-associated cryptococcal meningitis.” N Engl J Med 326 (1992): 83-9

7. Robinson PA, Knirsch AK, Joseph JA “Fluconazole for life-threatening fungal infections in patients who cannot be treated with conventional antifungal agents.” Rev Infect Dis 12 (1990): s349-63

8. Inman W, Pearce G, Wilton L “Safety of fluconazole in the treatment of vaginal candidiasis – a prescription-event monitoring study, with special reference to the outcome of pregnancy.” Eur J Clin Pharmacol 46 (1994): 115-8

9. Gupta AK, Ryder JE “The use of oral antifungal agents to treat onychomycosis.” Dermatol Clin 21 (2003): 469-79, vi

10. Thompson GR 3rd, Cadena J, Patterson TF “Overview of antifungal agents.” Clin Chest Med 30 (2009): 203-15, v

11. Ikemoto H “A clinical study of fluconazole for the treatment of deep mycoses.” Diagn Microbiol Infect Dis 12 (1989): s239-47

12. De Wit S, Clumeck N “Fluconazole in the treatment of fungal infections associated with AIDS.” Infection 17 (1989): 121-3

13. Vincent-Ballereau FN, Patey ON, Lafaix C “Fluconazole: review and situation among antifungal drugs in the treatment of opportunistic mycoses of human immuno-deficiency virus infections.” Pharm Weekbl Sci 13 (1990): 45-57

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Diflucan Side Effects

Medically reviewed by Drugs.com. Last updated on Nov 8, 2022.

Note: This document contains side effect information about fluconazole. Some dosage forms listed on this page may not apply to the brand name Diflucan.

Summary

More frequent side effects include: vomiting. Continue reading for a comprehensive list of adverse effects.

Applies to fluconazole: oral powder for suspension, oral tablet. Other dosage forms:

Serious side effects of Diflucan

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

Chest tightness
chills
clay-colored stools
cough
dark urine
diarrhea
difficulty with swallowing
dizziness
fast heartbeat
fever
headache
hives, itching, or skin rash
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
light-colored stools
loss of appetite
nausea
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
stomach pain, continuing
unpleasant breath odor
unusual tiredness or weakness
upper right abdominal or stomach pain
vomiting
vomiting of blood
yellow eyes and skin

Incidence not known

Black, tarry stools
blistering, peeling, or loosening of the skin
chest pain or discomfort
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 the arms and legs
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
seizures
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

Other side effects of Diflucan

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

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

For Healthcare Professionals

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

General

Nervous system

Seizures, dizziness, paresthesia, somnolence, tremor, and vertigo have also been reported during postmarketing experience. [Ref]

Very common (10% or more): Headache (up to 13%)

Uncommon (0.1% to 1%): Seizures, dizziness, paresthesia, somnolence, vertigo, visual field defect, taste perversion, hyperkinesia, hypertonia

Rare (less than 0.1%): Tremor

Frequency not reported: Dysesthesias [Ref]

Gastrointestinal

Dry mouth, dyspepsia, and vomiting have also been reported during postmarketing experience. [Ref]

Very common (10% or more): Nausea, abdominal pain, diarrhea, vomiting

Common (1% to 10%): Dyspepsia

Uncommon (0.1% to 1%): Constipation, flatulence, loose stools, dry mouth

Frequency not reported: General abdominal discomfort [Ref]

Hepatic

Very common (10% or more): Increased ALT, increased AST

Uncommon (0.1% to 1%): Serum transaminase elevations, cholestasis, jaundice, increased bilirubin

Rare (less than 0.1%): Serious hepatic reactions, hepatic toxicity (including fatalities), hepatic failure, hepatocellular necrosis, hepatitis, hepatocellular damage

Transient hepatic reactions have been reported in patients with no other identifiable risk factors. Liver function returned to baseline after stopping this drug.

Transaminase elevations greater than 2 to 3 x ULN have also been reported.

Cholestasis, hepatocellular damage, and hepatocellular necrosis have also been reported during postmarketing experience. [Ref]

Dermatologic

Very common (10% or more): Rash

Common (1% to 10%): Maculopapular erythema

Uncommon (0.1% to 1%): Pruritus, genital pruritus, erythematous rash, dry skin, abnormal skin odor, urticaria, herpes simplex, drug eruption, increased sweating

Frequency not reported: Reversible alopecia, exfoliative skin disorders (including fatalities) [Ref]

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 resulted in a fatal outcome.

Metabolic

Hypercholesterolemia, hypertriglyceridemia, and hypokalemia have also been reported during postmarketing experience. [Ref]

Very common (10% or more): Increased blood alkaline phosphatase

Uncommon (0.1% to 1%): Hypokalemia, anorexia, decreased appetite

Rare (less than 0.1%): Hypercholesterolemia, hypertriglyceridemia [Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity reactions (including generalized edema, stridor, hypotension, exfoliative dermatitis, ulcerative eruptions), fixed drug eruption

Postmarketing reports: Anaphylaxis (including angioedema, face edema, pruritus) [Ref]

Rare cases of exfoliative dermatitis and ulcerative eruptions consistent with Stevens-Johnson syndrome have been reported in association with hypersensitivity reactions.

Cardiovascular

Rare (less than 0.1%): QT prolongation, torsade de pointes

Frequency not reported: Prolongation of the QT interval on the ECG, palpitations, complex ventricular arrhythmia [Ref]

QT prolongation and torsade de pointes have also been reported during postmarketing experience. [Ref]

Hematologic

Uncommon (0.1% to 1%): Anemia

Frequency not reported: Eosinophilia [Ref]

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

Anemia, leukopenia, neutropenia, agranulocytosis, and thrombocytopenia have also been reported during postmarketing experience. [Ref]

Other

Fever, asthenia, fatigue, and malaise have also been reported during postmarketing experience. [Ref]

Uncommon (0.1% to 1%): Thirst, fatigue, malaise, pain, rigors, asthenia, fever, flushing, hot flushes

Rare (less than 0.1%): Face edema

Frequency not reported: Infection due to resistant microorganisms [Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Back pain, myalgia

Frequency not reported: Joint pain, finger stiffness [Ref]

Myalgia has also been reported during postmarketing experience. [Ref]

Psychiatric

Insomnia has also been reported during postmarketing experience.

Uncommon (0.1% to 1%): Insomnia, nervousness

Renal

Uncommon (0.1% to 1%): Polyuria, renal pain, changes in renal function tests

Frequency not reported: Membranous nephropathy

Postmarketing reports: Acute renal failure [Ref]

Genitourinary

Uncommon (0.1% to 1%): Intermenstrual bleeding, dysmenorrhea, leukorrhea, menorrhagia, uterine spasm, vaginal disorders, female sexual dysfunction

Respiratory

Frequency not reported: Respiratory disorders [Ref]

Ocular

Uncommon (0.1% to 1%): Abnormal vision

Frequently asked questions

Fluconazole – How long does it take to work?
Does fluconazole flush out yeast/discharge?
Fluconazole – can you drink alcohol while using one dose of 150mg one time?
What is the dose of fluconazole for tinea? Is it is indicated for tinea infections?
I am having a reaction after taking fluconazole and would like to know if this is normal?

More about Diflucan (fluconazole)

Check interactions
Compare alternatives
Pricing & coupons
Reviews (142)
Drug images
Dosage information
During pregnancy
Generic availability
Support group
Drug class: azole antifungals
Breastfeeding

Patient resources

Drug Information
Diflucan (Advanced Reading)
Diflucan IV (Advanced Reading)
Diflucan Intravenous (Advanced Reading)
Diflucan (Fluconazole Injection Solution)

Professional resources

Related treatment guides

Candida Urinary Tract Infection
Candidemia
Blastomycosis
Bone Marrow Transplantation