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 at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

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; dizziness; headache; nausea; stomach pain.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); diarrhea; scaly, red skin over a large portion of the body; swollen or tender abdomen; vomiting; yellowing of the skin or eyes.

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; nausea; stomach pain; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark urine; diarrhea; fever; hoarseness; irregular heartbeat; scaly, red skin over a large portion of the body; seizures; sore throat; swelling of your hands; unusual or severe stomach pain; unusual tiredness; yellowing of the eyes or skin.

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; dizziness; headache; nausea; stomach pain.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); diarrhea; pain or redness at the injection site; scaly, red skin over a large portion of the body; swollen or tender abdomen; vomiting; yellowing of the skin or eyes.

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; dizziness; headache; nausea; stomach pain.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); diarrhea; scaly, red skin over a large portion of the body; swollen or tender abdomen; vomiting; yellowing of the skin or eyes.

Fluconazole Side Effects - for the Professional

Fluconazole

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.

Postmarketing Experience

In addition, the following adverse events have occurred during postmarketing experience.

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

Cardiovascular: QT prolongation, torsade de pointes.

Central Nervous System: Seizures, dizziness.

Dermatologic: Exfoliative skin disorders including Stevens-Johnson syndrome and toxic epidermal necrolysis, alopecia.

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

Metabolic: Hypercholesterolemia, hypertriglyceridemia, hypokalemia.

Gastrointestinal: Dyspepsia, vomiting.

Other Senses: Taste perversion.

Adverse Reactions in Children:

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.

Side Effects by Body System

General

Fluconazole is generally well tolerated. In clinical trials, adverse events were reported more frequently in HIV patients than in non-HIV patients (21% vs. 13%).

Gastrointestinal

Gastrointestinal side effects were among the most common complaints. Nausea, vomiting, anorexia, general abdominal discomfort, and diarrhea occurred in 1% to 10% of all patients.

Hepatic

Hepatic side effects including transient, asymptomatic elevations of liver function tests occurred in up to 12% of patients. Hepatitis, cholestasis, and fatal hepatic necrosis have been reported rarely.

Rare cases of cholestatic jaundice, hepatitis and fulminant hepatic failure associated with fluconazole therapy have been reported, although some of these patients were on other potentially hepatotoxic medications or had severe underlying disease. Fatal hepatic toxicities have occurred primarily in patients with 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. Less than 1% of patients experience an eight-fold increase in liver function tests.

Dermatologic

Dermatologic side effects have been reported. Reversible alopecia has been associated with long-term (2 months or longer) therapy. Sweating has also been reported.

Nervous system

Nervous system side effects including headache, dizziness, and dysesthesias have been reported in 1% to 3% of treated patients. 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. Insomnia has also been reported.

Hypersensitivity

Hypersensitivity reactions have been reported rarely and usually manifested as a rash. Rashes have occurred in approximately 2% of patients. 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 Stevens-Johnson syndrome have been reported. At least one case of a fixed drug eruption has also been reported.

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.

Hematologic

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

Hematologic side effects have been rarely reported. Thrombocytopenia and eosinophilia have been the most frequently encountered, usually in patients with AIDS, although a causal relationship is not clear. Anemia, leukopenia, and neutropenia have also been reported.

Musculoskeletal

Musculoskeletal side effects including back and joint pain have been reported. Finger stiffness has been reported, although an association to therapy is questionable.

Cardiovascular

Cardiovascular side effects including prolongation of the QT interval and Torsades de Pointes ventricular tachycardia have been reported. Palpitations have also been reported.

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.

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.

Renal side effects including at least one case of membranous nephropathy have been reported.

Respiratory

Respiratory side effects including respiratory disorders have been reported.

Other

Other side effects including fever have been reported.

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