Fluconazole Side Effects

Brand Names: Diflucan

Please note - some side effects for Fluconazole may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Fluconazole - for the Consumer

Fluconazole

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Fluconazole:

Changes in taste; diarrhea; dizziness; headache; indigestion; mild stomach pain; nausea; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Fluconazole:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness; wheezing); burning, numbness, or tingling; dark urine; fever, chills, or persistent sore throat; irregular heartbeat; loss of appetite; muscle pain, weakness, or cramping; pale stools; red, swollen, blistered, or peeling skin; seizures; severe or persistent diarrhea, nausea, or vomiting; swelling of the hands; unusual bruising or bleeding; unusual or severe stomach pain; unusual tiredness; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Fluconazole Single-Dose Tablets

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Fluconazole Single-Dose Tablets:

Changes in taste; diarrhea; dizziness; headache; indigestion; mild stomach pain; nausea; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Fluconazole Single-Dose Tablets:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness; wheezing); burning, numbness, or tingling; dark urine; fever, chills, or persistent sore throat; irregular heartbeat; loss of appetite; muscle pain, weakness, or cramping; pale stools; red, swollen, blistered, or peeling skin; seizures; severe or persistent diarrhea, nausea, or vomiting; swelling of the hands; unusual bruising or bleeding; unusual or severe stomach pain; unusual tiredness; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Fluconazole Solution

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Fluconazole Solution:

Changes in taste; diarrhea; dizziness; headache; indigestion; mild stomach pain; nausea; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Fluconazole Solution:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness; wheezing); burning, numbness, or tingling; dark urine; fever, chills, or persistent sore throat; irregular heartbeat; loss of appetite; muscle pain, weakness, or cramping; pale stools; red, swollen, blistered, or peeling skin; seizures; severe or persistent diarrhea, nausea, or vomiting; swelling of the hands; unusual bruising or bleeding; unusual or severe stomach pain; unusual tiredness; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Fluconazole Suspension

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Fluconazole Suspension:

Changes in taste; diarrhea; dizziness; headache; indigestion; mild stomach pain; nausea; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Fluconazole Suspension:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness; wheezing); burning, numbness, or tingling; dark urine; fever, chills, or persistent sore throat; irregular heartbeat; loss of appetite; muscle pain, weakness, or cramping; pale stools; red, swollen, blistered, or peeling skin; seizures; severe or persistent diarrhea, nausea, or vomiting; swelling of the hands; unusual bruising or bleeding; unusual or severe stomach pain; unusual tiredness; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Fluconazole Side Effects - for the Professional

Fluconazole

Fluconazole 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 Fluconazole, 150 mg single dose. The overall incidence of side effects possibly related to Fluconazole 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 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 Fluconazole 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%.

Hepatobiliary

In combined clinical trials and marketing experience, there have been rare cases of serious hepatic reactions during treatment with Fluconazole. 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 Fluconazole.

In two comparative trials evaluating the efficacy of Fluconazole 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 Fluconazole 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.

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, increased sweating, exfoliative skin disorders including Stevens-Johnson syndrome and toxic epidermal necrolysis, 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 Fluconazole 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	Comparative Agents
	(N=577)	(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

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Side Effects by Body System - for Healthcare Professionals

General

Fluconazole is generally well tolerated. Changes in renal and hematological function test results and hepatic abnormalities have been reported during treatment with fluconazole 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 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 at least one case of a 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 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 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.

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