Diflucan Side Effects

Generic name: fluconazole

Medically reviewed by Drugs.com. Last updated on Oct 15, 2024.

Note: This document provides detailed information about Diflucan.

For healthcare professionals

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

General adverse events

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 Side Effects associated with fluconazole. Some dosage forms listed on this page may not apply specifically to the brand name Diflucan.

For healthcare professionals

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

General adverse events

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

• 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]

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]

Gastrointestinal

• 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]

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

• 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]

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

Hypersensitivity

• Rare (less than 0.1%): Anaphylactic reaction, anaphylaxis
• 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
• Rare (less than 0.1%): Leukopenia, neutropenia, agranulocytosis, thrombocytopenia
• 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

• 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]

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

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

Insomnia has also been reported during postmarketing experience.

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 (the active ingredient contained in Diflucan) 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

• Uncommon (0.1% to 1%): Pharyngitis
• Frequency not reported: Respiratory disorders^[Ref]

Ocular

• Uncommon (0.1% to 1%): Abnormal vision

Frequently asked questions

• Does fluconazole flush out yeast/discharge?
• How long does fluconazole take to work?
• 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'm having a reaction after taking fluconazole, is this normal?

Further information

Diflucan side effects can vary depending on the individual. 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.

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